At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Position Brand Description: Provides technical leadership for drug product manufacturing processes under development and in commercial production in the Dry Product Network. Key Objectives/Deliverables Serve as Manufacturing TS/MS representative to work with Product Development, CM&C teams, Manufacturing sites, and applicable functional areas to commercialize new dry oral solid drug products Leverage prior experience to anticipate commercial manufacturing challenges for new dry products. Work across Development and Manufacturing site(s) to implement appropriate product control strategies based on anticipated needs. Serve as the Global Molecule Steward for select oral solid dosage form drug products. Collaboratively integrate different disciplines such as engineering and analytical science on technical projects, process performance improvements, or control strategy effectiveness. Provide proficient data analysis and conclusions considering technical, Regulatory and Quality compliance, and business needs. Provide technical leadership for manufacturing process transfers between Lilly and external manufacturing sites as well as additional technical support/guidance for external manufacturing as needed. Drive appropriate shared learning, alignment and improvement across sites and network level activity according to best practices and technical principles. Ensure that experiments and technical work are well designed and appropriately rigorous. Use first principles and theoretical knowledge to define scientific approaches to support technical expectations. Utilize in depth understanding of materials, process, and product to improve product/process robustness, reduce variability, and provide improvement in control strategies across sites and technologies. Collaborate with Project Managers on key product project plans and support timely delivery of milestones with appropriate risk mitigation strategies. Leverage prior experience and knowledge as a Subject Matter Expert to collaborate with Development and manufacturing sites in the optimization of key manufacturing platforms such as continuous manufacturing. Influence Development on new product or platform topics in line with Manufacturing needs. Identify and lead the deployment of other new technology as appropriate. Author technical reports and appropriate sections of regulatory submission and responses as needed. Prepare technical aspects of other Regulatory/Quality based documents and support Regulatory reviews and inspections as needed. Remain current on external pharmaceutical manufacturing trends and innovations. Leverage these to improve strategies and applications for developing and controlling manufacturing processes. Prepare, review, and approve study designs, protocols, technical reports, and other related technical documentation. As a reviewer of technical reports, provide input on the experimental findings and conclusions. Mentor and provide review/coaching to develop other technical resources on scientific approach, technology, as well as business approach and behaviors. Achieve network level results for Lilly's dry products (oral solid dosage forms) that improve the business. Influence global leadership to drive improvements and resolve issues. Basic Requirements: Bachelor's Degree or higher in Chemistry, Engineering, Pharmacy, or related science. Minimum 7-10+ years of direct experience and technical expertise across multiple areas, unit operations, and platforms related to dry products (oral solid dosage forms) development, commercialization & commercial GMP-manufacturing. Additional Preferences: Demonstrated, strong technical leadership and communication skills. Communicates effectively across disciplines and types of audiences (internal and external) to influence and/or drive common understanding and appropriate actions. Ability to work well independently, as well as in teams. Provides partnership and collaboration across multiple disciplines. Ability to lead teams effectively. Demonstrated, strong analytical and problem solving abilities. Effective at integrating multiple technology disciplines to drive programs forward. Flexibility to interact with multiple partners/functions, regions, and cultures. Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
Mar 15, 2024
Full time
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Position Brand Description: Provides technical leadership for drug product manufacturing processes under development and in commercial production in the Dry Product Network. Key Objectives/Deliverables Serve as Manufacturing TS/MS representative to work with Product Development, CM&C teams, Manufacturing sites, and applicable functional areas to commercialize new dry oral solid drug products Leverage prior experience to anticipate commercial manufacturing challenges for new dry products. Work across Development and Manufacturing site(s) to implement appropriate product control strategies based on anticipated needs. Serve as the Global Molecule Steward for select oral solid dosage form drug products. Collaboratively integrate different disciplines such as engineering and analytical science on technical projects, process performance improvements, or control strategy effectiveness. Provide proficient data analysis and conclusions considering technical, Regulatory and Quality compliance, and business needs. Provide technical leadership for manufacturing process transfers between Lilly and external manufacturing sites as well as additional technical support/guidance for external manufacturing as needed. Drive appropriate shared learning, alignment and improvement across sites and network level activity according to best practices and technical principles. Ensure that experiments and technical work are well designed and appropriately rigorous. Use first principles and theoretical knowledge to define scientific approaches to support technical expectations. Utilize in depth understanding of materials, process, and product to improve product/process robustness, reduce variability, and provide improvement in control strategies across sites and technologies. Collaborate with Project Managers on key product project plans and support timely delivery of milestones with appropriate risk mitigation strategies. Leverage prior experience and knowledge as a Subject Matter Expert to collaborate with Development and manufacturing sites in the optimization of key manufacturing platforms such as continuous manufacturing. Influence Development on new product or platform topics in line with Manufacturing needs. Identify and lead the deployment of other new technology as appropriate. Author technical reports and appropriate sections of regulatory submission and responses as needed. Prepare technical aspects of other Regulatory/Quality based documents and support Regulatory reviews and inspections as needed. Remain current on external pharmaceutical manufacturing trends and innovations. Leverage these to improve strategies and applications for developing and controlling manufacturing processes. Prepare, review, and approve study designs, protocols, technical reports, and other related technical documentation. As a reviewer of technical reports, provide input on the experimental findings and conclusions. Mentor and provide review/coaching to develop other technical resources on scientific approach, technology, as well as business approach and behaviors. Achieve network level results for Lilly's dry products (oral solid dosage forms) that improve the business. Influence global leadership to drive improvements and resolve issues. Basic Requirements: Bachelor's Degree or higher in Chemistry, Engineering, Pharmacy, or related science. Minimum 7-10+ years of direct experience and technical expertise across multiple areas, unit operations, and platforms related to dry products (oral solid dosage forms) development, commercialization & commercial GMP-manufacturing. Additional Preferences: Demonstrated, strong technical leadership and communication skills. Communicates effectively across disciplines and types of audiences (internal and external) to influence and/or drive common understanding and appropriate actions. Ability to work well independently, as well as in teams. Provides partnership and collaboration across multiple disciplines. Ability to lead teams effectively. Demonstrated, strong analytical and problem solving abilities. Effective at integrating multiple technology disciplines to drive programs forward. Flexibility to interact with multiple partners/functions, regions, and cultures. Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Organization Overview: At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. Position Description: Senior Principal Associate - QA Site Compliance serves as the site inspection readiness steward to lead the inspection readiness program at the RTP site. The inspection readiness steward will have oversight of the inspection readiness program and processes and provide quality auditing expertise in regulation requirements for all aspects of manufacturing conducted at RTP. Key Objectives/Deliverables: Coordinates and manages regulatory inspections including logistics and data system(s). Implement and Lead the site inspection readiness program Implement and Lead the Quality Oversight program Acts as data steward and trainer for site audit data system(s) Leads inspection readiness huddles Monitor and report on the status and effectiveness of the inspection readiness program and needed improvements Perform local site impact assessments in response to Lilly site external inspection findings and external trendings in accordance with Lilly's regulatory change management program. Ensure awareness of applicable regulatory requirements and quality management system requirements throughout the organization Leads site initiatives related to quality and compliance; supports network initiatives related to quality and compliance for local implementation Serve as a quality and technical mentor/coach for interpretation and application of regulatory and global requirements for individual contributors and management at the site Lead and model behaviors foundational to strong quality culture Performs site self-inspections, as necessary Support site safety initiatives. Basic Requirements: BSc or MSc in scientific/technical discipline: chemistry, biology, microbiology, engineering or equivalent scientific/technical degree 10+ years of experience in pharmaceutical and/or medical device industry Preferred attributes but not required: Extensive knowledge of external Regulations and Lilly Quality System requirements Ability to function in a team environment as a leader and as a team member Demonstrated ability to partner/network with other sites Demonstrated participations in inspections and inspection readiness activities including acting as an audit host. Demonstrated ability to manage projects. Proficiency with computer systems. Multi product facility knowledge including parenteral drug product manufacturing, device assembly and packaging activities Good knowledge of cGMPs, ISO and quality management systems with demonstrated technical proficiency Strong communication and interpersonal skills with ability to influence multiple levels of the organization Strong self-management and organizational skills, ability to prioritize, critical decision-making skills, problem solving, mentorship and coaching skills. Self-motivation, lead the way for ensuring a fair and equitable work environment. Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals Additional Information: US/OUS travel may be required Flex hours possible Site operates 24/7 - overtime may be required Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
Mar 10, 2024
Full time
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Organization Overview: At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. Position Description: Senior Principal Associate - QA Site Compliance serves as the site inspection readiness steward to lead the inspection readiness program at the RTP site. The inspection readiness steward will have oversight of the inspection readiness program and processes and provide quality auditing expertise in regulation requirements for all aspects of manufacturing conducted at RTP. Key Objectives/Deliverables: Coordinates and manages regulatory inspections including logistics and data system(s). Implement and Lead the site inspection readiness program Implement and Lead the Quality Oversight program Acts as data steward and trainer for site audit data system(s) Leads inspection readiness huddles Monitor and report on the status and effectiveness of the inspection readiness program and needed improvements Perform local site impact assessments in response to Lilly site external inspection findings and external trendings in accordance with Lilly's regulatory change management program. Ensure awareness of applicable regulatory requirements and quality management system requirements throughout the organization Leads site initiatives related to quality and compliance; supports network initiatives related to quality and compliance for local implementation Serve as a quality and technical mentor/coach for interpretation and application of regulatory and global requirements for individual contributors and management at the site Lead and model behaviors foundational to strong quality culture Performs site self-inspections, as necessary Support site safety initiatives. Basic Requirements: BSc or MSc in scientific/technical discipline: chemistry, biology, microbiology, engineering or equivalent scientific/technical degree 10+ years of experience in pharmaceutical and/or medical device industry Preferred attributes but not required: Extensive knowledge of external Regulations and Lilly Quality System requirements Ability to function in a team environment as a leader and as a team member Demonstrated ability to partner/network with other sites Demonstrated participations in inspections and inspection readiness activities including acting as an audit host. Demonstrated ability to manage projects. Proficiency with computer systems. Multi product facility knowledge including parenteral drug product manufacturing, device assembly and packaging activities Good knowledge of cGMPs, ISO and quality management systems with demonstrated technical proficiency Strong communication and interpersonal skills with ability to influence multiple levels of the organization Strong self-management and organizational skills, ability to prioritize, critical decision-making skills, problem solving, mentorship and coaching skills. Self-motivation, lead the way for ensuring a fair and equitable work environment. Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals Additional Information: US/OUS travel may be required Flex hours possible Site operates 24/7 - overtime may be required Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Lilly is designing and building a new state of the art Parenteral, Device Assembly, and Packaging Facility located at the Research Triangle Park (RTP) in North Carolina. This is an exciting opportunity to help build and operate a state-of-the-art manufacturing site and Quality System from the ground up. The Sterility Assurance Steward- Technical Services / Manufacturing Science (TS/MS) is a role encompasses technical leadership and advisory roles in all aspects of sterility assurance of parenteral products, including but not limited to formulation, container closure, delivery systems, processing and manufacturing environment. The Sterility Assurance Steward develops and implements a technical agenda with three primary objectives: (1) reliable, compliant manufacturing of the drug product; (2) improvement of the process control strategy, continuous optimization, development and the innovation of technologies; (3) continual deepening of the scientific understanding of sterility assurance. The technical agenda exists throughout the entire product, process and facility lifecycle. A key attribute of this position includes assessment of existing strategies to identify areas for continuous improvement and development of new strategies for sterility assurance programs, including Contamination Control Strategy, Aseptic Process Simulation, Filter Validation, Container Closure Validation, Leaks and Glove Management, Environmental Monitoring, Facility Disinfection, Gowning and Hygiene, and Sterility Assurance Risk Management programs. At the Steward level, the scientist provides leadership and influence across the Parenteral Network. The scope of the role includes syringe filling and device assembly & packaging operations for commercially manufactured products targeted for transfer to the RTP site. Key Objectives / Deliverables: Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals. Understand the scientific principles required for manufacturing parenteral drug products, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems. Use sterility assurance risk management to evaluate existing and proposed manufacturing processes and associated controls with respect to the potential for introduction of microbial, endotoxin and particulate contamination. Lead and / or participate in complex projects associated with sterility assurance programs. Lead and / or assist in the development and execution of process and facility monitoring strategies that focus on areas of highest microbial risk (e.g., disinfectant/sanitizing agent evaluation, resident microflora evaluation, airflow pattern testing, environmental monitoring PQ, aseptic process simulations, etc.) Lead major deviations for root cause analysis related to sterility assurance programs. Remain abreast of external regulatory requirements associated with sterility assurance programs. Influence revision to corporate guidance associated with sterility assurance programs. Identify and implement continuous improvement for sterility assurance programs. Provide design input related to new processes (e.g., facilities, equipment, etc.) for RTP. Represents and defends the site's sterility assurance programs during internal audits and external regulatory inspections. Assists with writing of regulatory submissions for sterility assurance programs. Create, review, approve and provide sterility assurance training for new hires and personnel from other sites. Provide technical mentorship to a less senior scientists within the TS/MS organization. Provide technical mentorship to a less senior cross-functional personnel within RTP. Provide technical consultation across the Parenteral Network. Minimum Requirements: BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline Minimum 10 years' experience in the biopharmaceutical industry Additional Preferences: Masters Degree in Microbiology, Biology or related scientific field (or equivalent work experience) preferred Facility start-up and/or technical transfer experience, including environmental monitoring performance qualification and aseptic process simulations Prior experience in multiple functions associated with manufacture of parenteral products (e.g. operations, environmental monitoring, sterility assurance validation, microbiology laboratory, technical services, quality assurance, etc.) In depth knowledge of risk management and the understanding / ability to use risk assessment tools Ability to analyze complex data and solve problems Strong technical writing and presentation skills Teamwork / interpersonal skills ability to effectively influence Knowledge of microbiology and sterility assurance Other Information: Role is Monday through Friday based. Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.). Occasional extended hour and / or off-hour work may be required. Position will be based out of RTP site with ability to travel to Indianapolis and other global Lilly sites as required Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
Mar 04, 2024
Full time
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Lilly is designing and building a new state of the art Parenteral, Device Assembly, and Packaging Facility located at the Research Triangle Park (RTP) in North Carolina. This is an exciting opportunity to help build and operate a state-of-the-art manufacturing site and Quality System from the ground up. The Sterility Assurance Steward- Technical Services / Manufacturing Science (TS/MS) is a role encompasses technical leadership and advisory roles in all aspects of sterility assurance of parenteral products, including but not limited to formulation, container closure, delivery systems, processing and manufacturing environment. The Sterility Assurance Steward develops and implements a technical agenda with three primary objectives: (1) reliable, compliant manufacturing of the drug product; (2) improvement of the process control strategy, continuous optimization, development and the innovation of technologies; (3) continual deepening of the scientific understanding of sterility assurance. The technical agenda exists throughout the entire product, process and facility lifecycle. A key attribute of this position includes assessment of existing strategies to identify areas for continuous improvement and development of new strategies for sterility assurance programs, including Contamination Control Strategy, Aseptic Process Simulation, Filter Validation, Container Closure Validation, Leaks and Glove Management, Environmental Monitoring, Facility Disinfection, Gowning and Hygiene, and Sterility Assurance Risk Management programs. At the Steward level, the scientist provides leadership and influence across the Parenteral Network. The scope of the role includes syringe filling and device assembly & packaging operations for commercially manufactured products targeted for transfer to the RTP site. Key Objectives / Deliverables: Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals. Understand the scientific principles required for manufacturing parenteral drug products, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems. Use sterility assurance risk management to evaluate existing and proposed manufacturing processes and associated controls with respect to the potential for introduction of microbial, endotoxin and particulate contamination. Lead and / or participate in complex projects associated with sterility assurance programs. Lead and / or assist in the development and execution of process and facility monitoring strategies that focus on areas of highest microbial risk (e.g., disinfectant/sanitizing agent evaluation, resident microflora evaluation, airflow pattern testing, environmental monitoring PQ, aseptic process simulations, etc.) Lead major deviations for root cause analysis related to sterility assurance programs. Remain abreast of external regulatory requirements associated with sterility assurance programs. Influence revision to corporate guidance associated with sterility assurance programs. Identify and implement continuous improvement for sterility assurance programs. Provide design input related to new processes (e.g., facilities, equipment, etc.) for RTP. Represents and defends the site's sterility assurance programs during internal audits and external regulatory inspections. Assists with writing of regulatory submissions for sterility assurance programs. Create, review, approve and provide sterility assurance training for new hires and personnel from other sites. Provide technical mentorship to a less senior scientists within the TS/MS organization. Provide technical mentorship to a less senior cross-functional personnel within RTP. Provide technical consultation across the Parenteral Network. Minimum Requirements: BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline Minimum 10 years' experience in the biopharmaceutical industry Additional Preferences: Masters Degree in Microbiology, Biology or related scientific field (or equivalent work experience) preferred Facility start-up and/or technical transfer experience, including environmental monitoring performance qualification and aseptic process simulations Prior experience in multiple functions associated with manufacture of parenteral products (e.g. operations, environmental monitoring, sterility assurance validation, microbiology laboratory, technical services, quality assurance, etc.) In depth knowledge of risk management and the understanding / ability to use risk assessment tools Ability to analyze complex data and solve problems Strong technical writing and presentation skills Teamwork / interpersonal skills ability to effectively influence Knowledge of microbiology and sterility assurance Other Information: Role is Monday through Friday based. Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.). Occasional extended hour and / or off-hour work may be required. Position will be based out of RTP site with ability to travel to Indianapolis and other global Lilly sites as required Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
Year Round We are looking for people who are passionate about life and what they do. People who love the mountain lifestyle and who want to be at Snowshoe! We seek qualified candidates that exemplify our Core Values of Honoring Authenticity, Embracing Empowerment, Cultivating Collaboration, and Prioritizing Purpose. Our goal at Snowshoe is to provide exceptional mountain experiences for our guests, employees, and community. We do so by embracing authenticity, celebrating our differences, and finding ways we can all connect through our shared passion for the mountain. At Snowshoe everyone is welcome, and we encourage you to be yourself. Simply put, you belong up here and we can't wait to see you on the mountain! Work, Play, Get Paid and Enjoy the Perks: Free skiing + riding privileges with direct to lift access at 14 iconic resorts including: Snowshoe Mountain, Stratton, Palisades Tahoe, Mammoth Mountain, Steamboat and more! 401(k) plan (Available to any employee over the age of 18) 12 Discounted Friends and Family $25 Winter Lift Ticket Vouchers 30% - 45% off Snowshoe food & beverage locations (excludes alcohol) 30% off soft goods and 15% off hard goods at Snowshoe owned retail locations. Pro Deals from some of the industries top brands such as Smartwool, Smith, Dakine and North Face POSITION SUMMARY Join us in bringing a little spice to the mountain life here at Snowshoe as an Outlet Chef at our Sunset Cantina location. Sunset Cantina is centrally located in our main village area, known for delicious house-made margaritas, and serving traditional Southwest dishes with a twist. To provide an expedited and precise food product for Snowshoe Mountain, WV. Number of positions that report directly to this position: up to 30 (varies by outlet). Titles of positions that report directly to this position: Sous Chef/Line Cooks/Utility workers. RESORT OVERVIEW, CULTURE AND VISION Snowshoe is the premier destination for Mid-Atlantic and Southeast winter and summer enthusiasts. We offer 257 acres of skiable terrain, 1500 vertical feet, 61 ski trails and the best snow around. In the summer, our Bike Park is recognized as one of the best in the US. Enjoy our world class events, cool mountain temperatures, beautiful vistas and 11,000 acres of unspoiled wilderness. We hope to see you on the mountain soon. OUR VALUES Our organizational values describe our shared beliefs, the principles important to our organization; how we want to treat each other and our guests. Honoring Authenticity, Embracing Empowerment, Cultivating Collaboration, Prioritizing Purpose PERKS & BENEFITS Free season pass (summer/winter) Friends and family discounts and vouchers Pro deals with top industry brands Retail, lodging, and dining discounts at Snowshoe owned establishments Opportunities to grow your career and professional skills ESSENTIAL DUTIES This position is responsible for the following: Manage all aspects of the kitchen including operational, quality and administrative functions Actively seek verbal feedback from customers on a regular basis and respond to all guest queries in a timely and efficient manner. Ensuring adequate resources are available according to business needs Manage the provision of food to assigned outlet and taking action where necessary to ensure compliance with current legislation Control costs without compromising standards, improving gross profit margins and other departmental and financial targets Ensure team members have an up-to-date knowledge of menu items, special promotions, functions and events Maintain good communication and work relationships in all hotel areas Ensure that staffing levels are maintained to cover business demands Ensure monthly communication meetings are conducted and post-meeting minutes generated Manage staff performance issues in compliance with company policies and procedures Recruit, manage, train and develop the kitchen team Comply with public safety, fire regulations and all health and safety and food safety legislation Ensure maintenance, hygiene and hazard issues are dealt with in a timely manner Manage financial performance of the department so all planning is in line with resort objectives Ensure food control systems are adhered to so margins are on target Regular review of all menus with Executive Chef to confirm offerings are in line with market trends and company objectives Be environmentally aware Perform any other job related duties as assigned This job description is an overview of the scope of responsibilities and is not intended to be an inclusive list of job tasks and expectations. With the evolution of this resort and position, the responsibilities of this position may change. QUALIFICATIONS, KNOWLEDGE, SKILL AND ABILITY REQUIREMENTS Strong knife handling skills Experience with ovens, grills, broilers, saute, fryers and other culinary instruments Knowledge of safe food handling Requires practical knowledge of the principles and practices within the food profession. This includes experiential knowledge required for management of people and/or complex problems and food and beverage management. Leadership skills to motivate and develop staff and to ensure accomplishment of goals. Ability to work effectively under time constraints and deadlines DIRECT EXPERIENCE Education: Two+ years of post-high school education, culinary education is desirable. Resort experience preferred. West Virginia Food Handlers Certificate required. Experience: Five+ years of employment in a related position Experience managing a kitchen and developing staff Experience managing food costs Excellent leadership, interpersonal and communication skills Accountable and resilient Committed to delivering a high level of customer service Ability to work under pressure Intermediate food hygiene qualification Flexibility to respond to a range of different work situations LEADERSHIP Understands business complexities and assumes responsibility for driving change Leads employees or teams of employees to achieve goals Guides employees through periods of change, even during difficult times or in the face of hard business decisions Exhibits honesty, integrity in an environment of mutual respect and trust, core values, reliability ENGAGEMENT Is inquisitive and curious, always asking questions; Seeks new and/or different or ways to improve the business; Thinks outside the box Is recognized by others (internally and externally) as being engaged in their role, and someone who can often see things that others have not Inspires, motivates, develops, energizes, and creates engaged employees, with a solid record of employee retention Demonstrates true passion for the job, the resort, and the company overall Displays rigorous commitment to the environment, financial and safety of self, business, and inherent risks through stewardship. COMMUNICATION Communicates clearly and appropriately - both orally and in writing Responds to questions or requests in a timely manner Conducts regular one-on-one and departmental meetings to ensure a good flow of information Recognizes and rewards the achievement of his/her team and others; Ensures thank-yous are delivered All communication is down home and strives to improve upon a high level of guest service in a friendly manner Proficient in use of technology to include Excel, Word, the Internet, desktop publishing and database management software programs. Is able to learn quickly those applications not known. DELIVERY Achieves high-quality business outcomes for the division as well as delivering good results that help the business overall Delivers highly accurate end-work product personally and through overseeing others Able to analyze numbers and draw conclusions from statistical information Meets or exceeds financial goals, budgets, forecasts Creates successful strategies that produce results, but is also willing to accept responsibility for shortfalls when appropriate Ensures a guest driven atmosphere and improves commitment to a service level that exceed our guests' expectations FLEXIBILITY Adapts and is flexible to changing business circumstances across a season, a fiscal year, and/or multiple years; Exhibits willingness to change Adjusts budgets and reforecasts as needed across the year based on changing business needs Exhibits flexibility in their thinking, will bend when needed, and will lobby others to change when necessary Inspires a unified team through understanding was is required for successful, cooperative and fun team success TRAVEL REQUIREMENTS Any employee or volunteer who operates a company vehicle including cars, trucks, snowcats, snowmobiles, or heavy equipment is required to comply with the Driver's Standards Policy. This policy also applies to employees or volunteers driving their personal vehicles for company business more than four times per month, averaging 30+ miles per trip . click apply for full job details
Mar 28, 2024
Full time
Year Round We are looking for people who are passionate about life and what they do. People who love the mountain lifestyle and who want to be at Snowshoe! We seek qualified candidates that exemplify our Core Values of Honoring Authenticity, Embracing Empowerment, Cultivating Collaboration, and Prioritizing Purpose. Our goal at Snowshoe is to provide exceptional mountain experiences for our guests, employees, and community. We do so by embracing authenticity, celebrating our differences, and finding ways we can all connect through our shared passion for the mountain. At Snowshoe everyone is welcome, and we encourage you to be yourself. Simply put, you belong up here and we can't wait to see you on the mountain! Work, Play, Get Paid and Enjoy the Perks: Free skiing + riding privileges with direct to lift access at 14 iconic resorts including: Snowshoe Mountain, Stratton, Palisades Tahoe, Mammoth Mountain, Steamboat and more! 401(k) plan (Available to any employee over the age of 18) 12 Discounted Friends and Family $25 Winter Lift Ticket Vouchers 30% - 45% off Snowshoe food & beverage locations (excludes alcohol) 30% off soft goods and 15% off hard goods at Snowshoe owned retail locations. Pro Deals from some of the industries top brands such as Smartwool, Smith, Dakine and North Face POSITION SUMMARY Join us in bringing a little spice to the mountain life here at Snowshoe as an Outlet Chef at our Sunset Cantina location. Sunset Cantina is centrally located in our main village area, known for delicious house-made margaritas, and serving traditional Southwest dishes with a twist. To provide an expedited and precise food product for Snowshoe Mountain, WV. Number of positions that report directly to this position: up to 30 (varies by outlet). Titles of positions that report directly to this position: Sous Chef/Line Cooks/Utility workers. RESORT OVERVIEW, CULTURE AND VISION Snowshoe is the premier destination for Mid-Atlantic and Southeast winter and summer enthusiasts. We offer 257 acres of skiable terrain, 1500 vertical feet, 61 ski trails and the best snow around. In the summer, our Bike Park is recognized as one of the best in the US. Enjoy our world class events, cool mountain temperatures, beautiful vistas and 11,000 acres of unspoiled wilderness. We hope to see you on the mountain soon. OUR VALUES Our organizational values describe our shared beliefs, the principles important to our organization; how we want to treat each other and our guests. Honoring Authenticity, Embracing Empowerment, Cultivating Collaboration, Prioritizing Purpose PERKS & BENEFITS Free season pass (summer/winter) Friends and family discounts and vouchers Pro deals with top industry brands Retail, lodging, and dining discounts at Snowshoe owned establishments Opportunities to grow your career and professional skills ESSENTIAL DUTIES This position is responsible for the following: Manage all aspects of the kitchen including operational, quality and administrative functions Actively seek verbal feedback from customers on a regular basis and respond to all guest queries in a timely and efficient manner. Ensuring adequate resources are available according to business needs Manage the provision of food to assigned outlet and taking action where necessary to ensure compliance with current legislation Control costs without compromising standards, improving gross profit margins and other departmental and financial targets Ensure team members have an up-to-date knowledge of menu items, special promotions, functions and events Maintain good communication and work relationships in all hotel areas Ensure that staffing levels are maintained to cover business demands Ensure monthly communication meetings are conducted and post-meeting minutes generated Manage staff performance issues in compliance with company policies and procedures Recruit, manage, train and develop the kitchen team Comply with public safety, fire regulations and all health and safety and food safety legislation Ensure maintenance, hygiene and hazard issues are dealt with in a timely manner Manage financial performance of the department so all planning is in line with resort objectives Ensure food control systems are adhered to so margins are on target Regular review of all menus with Executive Chef to confirm offerings are in line with market trends and company objectives Be environmentally aware Perform any other job related duties as assigned This job description is an overview of the scope of responsibilities and is not intended to be an inclusive list of job tasks and expectations. With the evolution of this resort and position, the responsibilities of this position may change. QUALIFICATIONS, KNOWLEDGE, SKILL AND ABILITY REQUIREMENTS Strong knife handling skills Experience with ovens, grills, broilers, saute, fryers and other culinary instruments Knowledge of safe food handling Requires practical knowledge of the principles and practices within the food profession. This includes experiential knowledge required for management of people and/or complex problems and food and beverage management. Leadership skills to motivate and develop staff and to ensure accomplishment of goals. Ability to work effectively under time constraints and deadlines DIRECT EXPERIENCE Education: Two+ years of post-high school education, culinary education is desirable. Resort experience preferred. West Virginia Food Handlers Certificate required. Experience: Five+ years of employment in a related position Experience managing a kitchen and developing staff Experience managing food costs Excellent leadership, interpersonal and communication skills Accountable and resilient Committed to delivering a high level of customer service Ability to work under pressure Intermediate food hygiene qualification Flexibility to respond to a range of different work situations LEADERSHIP Understands business complexities and assumes responsibility for driving change Leads employees or teams of employees to achieve goals Guides employees through periods of change, even during difficult times or in the face of hard business decisions Exhibits honesty, integrity in an environment of mutual respect and trust, core values, reliability ENGAGEMENT Is inquisitive and curious, always asking questions; Seeks new and/or different or ways to improve the business; Thinks outside the box Is recognized by others (internally and externally) as being engaged in their role, and someone who can often see things that others have not Inspires, motivates, develops, energizes, and creates engaged employees, with a solid record of employee retention Demonstrates true passion for the job, the resort, and the company overall Displays rigorous commitment to the environment, financial and safety of self, business, and inherent risks through stewardship. COMMUNICATION Communicates clearly and appropriately - both orally and in writing Responds to questions or requests in a timely manner Conducts regular one-on-one and departmental meetings to ensure a good flow of information Recognizes and rewards the achievement of his/her team and others; Ensures thank-yous are delivered All communication is down home and strives to improve upon a high level of guest service in a friendly manner Proficient in use of technology to include Excel, Word, the Internet, desktop publishing and database management software programs. Is able to learn quickly those applications not known. DELIVERY Achieves high-quality business outcomes for the division as well as delivering good results that help the business overall Delivers highly accurate end-work product personally and through overseeing others Able to analyze numbers and draw conclusions from statistical information Meets or exceeds financial goals, budgets, forecasts Creates successful strategies that produce results, but is also willing to accept responsibility for shortfalls when appropriate Ensures a guest driven atmosphere and improves commitment to a service level that exceed our guests' expectations FLEXIBILITY Adapts and is flexible to changing business circumstances across a season, a fiscal year, and/or multiple years; Exhibits willingness to change Adjusts budgets and reforecasts as needed across the year based on changing business needs Exhibits flexibility in their thinking, will bend when needed, and will lobby others to change when necessary Inspires a unified team through understanding was is required for successful, cooperative and fun team success TRAVEL REQUIREMENTS Any employee or volunteer who operates a company vehicle including cars, trucks, snowcats, snowmobiles, or heavy equipment is required to comply with the Driver's Standards Policy. This policy also applies to employees or volunteers driving their personal vehicles for company business more than four times per month, averaging 30+ miles per trip . click apply for full job details