1+ months

Drug Product Manufacturing Associate

Company Info

Teva 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 Description

 

The 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&D 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.
Qualifications

 

Minimum Qualifications:

  • Bachelor's degree in Microbiology, Biology, Engineering, Science or related field of study
  • Minimum 2 years of drug product manufacturing experience in GMP pharmaceutical environment
  • Vision 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 performed


 

Preferred 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&D and clinical manufacturing.
  • Experience operating and troubleshooting parenteral filling equipment.
  • Experience in visual inspection of parenteral products.
  • Excellent communication skills
Reports To

Manager, Drug Product Operations

Already Working @TEVA?

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.

Categories

Posted: 2020-09-22 Expires: 2020-11-22

Join us at the forefront of pharmaceutical research and production. With state-of-the-art facilities, highly skilled colleagues, and a high-powered organizational culture, Teva offers you countless possibilities to make a real difference in people's lives and add value to your career.

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Drug Product Manufacturing Associate

Teva Pharmaceuticals

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