Job Details

Summary:

The position will actively contribute to manufacturing projects at the site. As part of the Cell Culture/Upstream Manufacturing group, you will have opportunities to work on and take ownership of a wide-ranging set of projects for troubleshooting and investigations, system and workflow implementation, and tech transfers of processes into a GMP multi-product manufacturing facility. The role will support process monitoring, GMP readiness, and manufacturing activities. The scope of responsibilities may include but are not limited to document writing (SOPs, Equipment URSs, etc.), batch record testing and review, equipment validation execution support, and single-use assembly design.

Responsibilities:

• Support upstream operations including but not limited to media prep; cell culture thaw, expansion, and cell banking; operation of single-use bioreactors, process monitoring, and harvest operations.
• Performs internal support activities such as maintenance of analytical equipment, stocking of consumables, discarding expired reagents, and material coordination.
• Maintains own training within compliance and trains other GMP associates upon completion of trainer qualification.
• Support in equipment troubleshooting, pilot scale material generation, non-GMP tox material generation and GMP Upstream activities.
• Author/review/approve technical documents such as tech transfer protocols and reports, experimental plans, production batch records, training materials, manufacturing SOPs, and regulatory filing documents per project needs.
• Documents work according to cGMP and cGDP.
• Adheres to established regulations and follows cGMP established by site.
• Maintain cleanroom standards, practices, and housekeeping according to SOPs.
• Recognize any minor issues from the equipment and any affiliated documentation and take appropriate corrective action within scope. Notify leads/managers of issues and discrepancies immediately.
• Assess impact of issues and non-conformities to products and projects as they pertain to product safety and efficacy or project milestones.
• Evaluate new technologies and innovations to improve operational efficiency or expand cell culture capabilities.
• Contributes to quality activities such as investigations and area walk-throughs and support authoring deviations, CAPA, change control.
• MSAT support, Material receipt, and inventory organization.
• Other duties as assigned to ensure appropriate compounding practices.

Working Conditions:

• This position is required to work in a lab/office setting. The role requires walking, standing, stooping, kneeling, and crouching. The employee must occasionally lift and or move up to 20 pounds independently.

Qualifications:

• BS in Engineering, Life Sciences, or related discipline with 1-2 years of relevant experience; AA degree with combination of industry experience and relevant degree; or combination of experience and relevant advanced degree, preferably in biopharma manufacturing role.
• Must have bioreactor operations experience.
• Basic understanding of mammalian cell culture performance is required.
• Experience with process monitoring software and equipment software (AVEVA/Wonderware) is a plus.
• Working knowledge of cGMP compliance as it pertains to procedures, processes, and manufacturing.
• Creative thinker that can identify better and more efficient methods to address issues and gaps.
• Demonstrate ability to work independently and on cross-functional teams.
• Ability to handle more than one task at a time, while maintaining attention to detail and working in a fast-paced environment.
• Strong analytical skills and attention to detail.
• Flexible mindset for a dynamic environment.
• Flexibility with work hours to meet business needs, including weekends and holidays, as needed.