Teva Pharmaceuticals Upstream Manufacturing Associate I in West Chester, Pennsylvania
Upstream Manufacturing Associate I
Date: Apr 8, 2021
Location: West Chester, Pennsylvania, US, 19380
Company: Teva Pharmaceuticals
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
Your new role will report to the Sr Manager, Upstream Manufacturing, Biologics CMC, West Chester
• Responsible for product-related operations in cell culture/fermentation and bioreactor operations. Primarily focused on cell culture activities; secondary focus and small scale inoculum preparation.
• Operates and maintains production equipment as it relates to cell culture – fermentation. Including, but not limited to: calibrations, preventative maintenance, initiating work orders, etc.
• Performs a variety of complex tasks under general guidance and in accordance with current GMPs.
• Experienced with drafting, executing, documenting and reviewing data, and approval of SOP’s and batch records according to GMP guidelines.
• Maintain records to comply with regulatory requirements and performs daily in-process testing.
• Provides detailed observations, analyzes data, and interprets results.
• Initiates deviations, assesses product quality impact, and proposes and executes Corrective and Preventative Actions (CAPA).
• Change owner for implementation or revision of equipment, documentation, and material specifications.
• Maintains daily workload schedule and relevant resource requirements.
• Proposes implementation of production procedures 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.
• Provides training to new personnel in a specific technical process.
• Assisting in audits from internal or external partners.
• Performs other related duties as required.
• Transparent and adheres to quality standards set by regulations and GMP policies, procedures and mission.
• Communicates effectively with managers, colleagues and subordinates.
• Ability to participate effectively as a team player in all aspects of GMP’s.
• Demonstrated administrative leadership with knowledge-based expertise in related areas that can be applied to meeting GMP’s strategic goals.
• Travels as needed.
• Associates degree with a minimum of 2 years’ experience in upstream mammalian cell culture or upstream process development.
• Knowledge of cell culture process steps including cell banking, thaw and expansion, production, and harvest.
• Experienced with manufacturing of bulk drug substance following SOPs and batch records within a cGMP regulated environment.
• Knowledge of specific product-related operations in cell culture/fermentation.
• Ability to ensure plans and resources (people, facilities, supplies etc.) are efficiently utilized to ensure uninterrupted supply of products produced.
• Ability to mentor and train colleagues.
• Weekend work and occasional Holiday work is required
• 1st shift to meet manufacturing process schedule.
• Available for On-call requirements such as; acknowledging alarms, remotely monitoring the process, and physically responding to alarm situations if necessary during off shift hours.
• Preferred BS degree in Chemical Engineering, Biotechnology, Biology, Chemistry or related Engineering discipline with 2-4 years mammalian cell culture experience, or MS with at least 1 years’ experience in upstream mammalian cell culture and cGMP manufacturing.
• Single use bioreactor and single use media preparation experience.
• Ability to observe technical issues and directs 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 GMP’s.
• Ability to work on complex assignments of diverse scope and ability to exercise judgment within defined procedures and practices to determine appropriate actions.
Research & Development
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