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Upstream Manufacturing Associate
Ref No.: 18-08234
Location: West Chester, Pennsylvania
Start Date: 07/09/2018
Position Responsibilities:
  • 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.
General Responsibilities:
  • 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.
Qualifications/Skills Required:
  • Associates degree with a minimum of 5 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.
  • Skill leading upstream production in absence of Associate Manager.
  • 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.
  • Occasional off shift work and weekend work.
  • 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 mammalian cell culture experience, or MS with at least 2 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.