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Manufacturing Associate, Downstream Purification

Date: Apr 26, 2021

Location: West Chester, Pennsylvania, US, 19380

Company: Teva Pharmaceuticals

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!


Teva’s Global Research & Development (R&D) organization is devoted to the development of new medicines, devices and combination products that provide meaningful therapeutic benefit to patients worldwide. Combining creativity, scientific rigor and our extensive knowledge on a broad range of technologies, our scientists, engineers, medical doctors and project leaders across the globe use their expertise to innovate novel biologics, biosimilars, small molecule specialty medicines, generics and over-the-counter therapies



Job Description

Reports to: Downstream Purification Management:

Position Responsibilities:

• Operates and maintains production equipment as it relates to purification – including analytical instrumentation to support downstream activities and in-process testing.
• Performs a variety of complex tasks under general guidance and in accordance with cGMPs.
• Responsible for drafting of batch records and SOPs, executing, documenting and reviewing data, and review and approval of manufacturing documents according to cGMP guidelines.
• Maintain records to comply with regulatory requirements.
• Initiates deviations, assesses product quality impact, and proposes, owns and executes Corrective and Preventive Actions (CAPA).
• Change owner for implementation or revision of equipment, documentation, and material specifications.
• Maintains daily work schedule and relevant resource requirements.
• Proposes implementation of improvements to optimize manufacturing processes. Monitor processes and results and suggest methods to ensure process success.
• Develops effective working relationships with both internal and external partners.

General Responsibilities:

• Transparent and adheres to quality standards set by regulations and cGMP policies, procedures and mission.
• Communicates effectively with managers, colleagues and subordinates.
•  Team player in all aspects of cGMP- compliant production activities.


Qualifications/Skills Required:

• Associates degree with a minimum of 2 years of hands-on experience in downstream purification processes for monoclonal antibodies or other biological drugs.
• Knowledge of Purification process steps including Chromatography, normal-flow filtration, virus filtration and UF/DF.
• Experienced with manufacturing of drug substance following SOPs and batch records within a cGMP regulated environment.
• Knowledge of specific product-related operations in downstream purification.
• Skilled in downstream production independently with limited supervision.
• Ability to ensure that plans and resources (people, facilities, supplies etc.) are efficiently utilized to ensure uninterrupted supply of products produced.
• Occasional off shift work and weekend work will be required.
• 1st shift and/or possible swing shift, if necessary to meet manufacturing process schedule.
• On-call required for acknowledging alarms from equipment during off shift hours.


Qualifications/Skills Preferred:

• Preferred BS degree in Chemical Engineering, Biotechnology, Biology, Chemistry or related Engineering discipline with 3-5 years purification process development experience, or MS with at least 2 years’ experience in downstream purification process development in addition to the required manufacturing and supervisory experience.
• Ability to observe technical issues and direct troubleshooting of process and equipment problems.
• Ability to operate with minimal supervision of complex systems and equipment and optimizes their use in manufacturing in accordance with the cGMPs.
• Ability to work on complex assignments of diverse scope and ability to exercise judgment within defined procedures and practices to determine appropriate actions.



Sub Function

Reports To

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Teva’s Equal Employment Opportunity Commitment

Teva 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.


We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to  support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience. 

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