Drug Product Manufacturing Associate

  • Rentokil
  • Oct 14, 2020
Full time Other

Job Description

Company InfoTeva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!Located in West Chester, PA, Teva Pharmaceuticals is responsible for the discovery and development of biologic medicines. The rapidly growing staff of Teva Biologics CMC, now nearly one hundred, specializes in the development of innovative biologics, biosimilars, and extended half-life bio-betters. We currently are developing products in various stages of clinical development from IND through BLA filing. Teva combines the financial stability of a large company with a small-company mentality emphasizing scientific-rigor and flexibility within a Regulatory and Quality context.Job DescriptionThe Drug Product Manufacturing Associate is responsible for performing all functions related to the manufacture of sterile drug products.This is a hands-on manufacturing position with excellent growth potential. You will work as part of a small team to deliver clinical batches in a fast-paced, highly innovative R environment. You will have the opportunity to work with the latest state-of-the-art filling technology, as well as collaborate with colleagues across the drug development, analytical, engineering, validation, and quality areas.Sterile drug product manufacture is the closest manufacturing process to the patient, so it is essential that individuals working in this area have the highest level of personal integrity and maturity, as well as a commitment to continuous process improvement.As a Drug Product Manufacturing Associate you will perform all routine production activities needed for the manufacture of sterile DP, including but not limited to: compounding and dilution of bulk biological drug substance, operation of the filling line and isolator systems, isolator glove interventions during operations using aseptic technique, filter integrity testing, preparation of components and supplies, GMP documentation (batch records, logbooks), and cleaning of critical process equipment. In addition you will visually inspect finished drug product units.RESPONSIBILITIES:Production of clinical drug product (DP) batches; directly accountable for right first time quality.Author and update procedures, work instructions, validation protocols, batch records, rationale documents, risk assessments, engineering studies, and other technical and quality documentation required to manufacture clinical DP batches and maintain compliance with all regulatory requirements.Perform quality investigations, validation activities, and change controls as needed.Perform technical troubleshooting of the filling line and related systems. Work collaboratively across multiple support teams (QA, QC, Validation, Maintenance, Product Development) to identify and resolve routine and complex issues.QualificationsMinimum Qualifications:Bachelor's degree in Microbiology, Biology, Engineering, Science or related field of studyMinimum 2 years of drug product manufacturing experience in GMP pharmaceutical environmentVision requirement: Must be 20/20 near vision (with or without correction), and normal color vision is required due to inspection requirements of the position; Mandatory yearly vision assessment will be performedPreferred Qualifications:Experience working in a hands-on cGMP environment manufacturing environment with strong preference given to experience in aseptic processing using isolators and/or RABS technologies.Basic understanding of microbiology, HVAC, and environmental monitoring as they relate to the manufacture of sterile drug products.Experience in technology transfers of drug product processes between R and clinical manufacturing.Experience operating and troubleshooting parenteral filling equipment.Experience in visual inspection of parenteral products.Excellent communication skillsReports ToManager, Drug Product OperationsAlready ?If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.Teva's Equal Employment Opportunity CommitmentTeva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.