The Manufacturing Associate is responsible for performing critical functions related to the manufacture of biological drug products. This is a hands-on manufacturing position. 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.
RESPONSIBILITIES:
• Perform final visual inspection of sterile drug products, including vial and syringe formats.
• Perform raw material weighing and dispensing material to media and buffer formulation group.
• Perform raw material sampling and manage the sampling process in alignment with the Quality Control unit.
• Update procedures, work instructions, validation protocols, batch records, rationale documents, risk assessments, engineering studies, and other technical and quality documentation required to manufacture clinical batches and maintain compliance with all regulatory requirements.
• Perform quality investigations, validation activities, and change controls as needed.
• Associates will also support the manufacturing team as needed to perform all routine production activities needed for the manufacture biologic medicines, including but not limited to: compounding and dilution of bulk biological drug substance, media, and buffers; 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.
REQUIRED QUALIFICATIONS:
• Minimum of 5 years’ experience in a GMP pharmaceutical production environment
• Minimum of 2 years performing manual visual inspection of parenteral drug product in alignment with current industry and health authority standards.
• Ability to perform basic calculations to accurately determine quantities of raw materials to sample and dispense, and record data accurately and completely in batch records.
• Vision requirement: 20/20 near vision (with or without correction), and normal color vision is required.
• Respirator use (full face and/or positive air pressure respirator – PAPR) is required. Ability to obtain medical clearance for respirator use is a mandatory job requirement.
• This is a full-time, 5 days per week on-site manufacturing position; hybrid or remote work is not available for this role. Occasional off-shift and weekend work may be required.
PREFERRED QUALIFICATIONS:
• BS degree in a scientific or technical field relevant to pharmaceutical manufacturing
• Basic understanding of microbiology, HVAC, and environmental monitoring as they relate to the manufacture of biologic drug products.
We are strengthening and adding to our critical teams with great talent and capabilities: Teva, a global organization with a brand of evolving success. Be part of it!
We offer a competitive benefits package, including Medical, Dental, Vision, and Prescription coverage starting on the first day. We also offer Disability and Life Insurance, Paid Time Off, Paid Holidays, 6% match on the 401(k), Employee Stock Purchase Plan, and Tuition Assistance.
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.