Bioprocess Specialist, Downstream Processing

Job Scope:

The Bioprocess Specialist works within the Downstream Processing group.  The Bioprocess Specialist will perform the following activities while executing downstream operations:

·       Preparation of solutions

·       Filtration

·       Chromatography

·       Tangential flow filtration

·       Homogenizing

·       Drug substance formulation

·       Drug product formulation

·       Drug product vial filling

The incumbent works cross-functionally with internal departments and external resources on gene therapy manufacturing related issues. 

The incumbent supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate. 

Position Information:

Worl Location: Pennington, NJ

Reports to: Senior Manager, Downstream Process

Roles and Responsibilities:

• Executes routine complex manufacturing assignments per written procedures; recognizes deviations from procedures and raises issue to management for resolution.
• Adheres to current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOPs).
• Performs routine microbial and mammalian cell culture using aseptic techniques.  Monitors microbial fermenters and mammalian cell cultures bioreactors.
• Weighs and checks raw materials, assembles process equipment, and monitors processes.
• Completes work instructions and maintains clean room environment to comply with regulatory requirements. Removes red bag waste as required.
• Operates all production equipment in assigned functional area such as disposable fermenters, bioreactors, other disposable Bioprocess equipment, and media preparation equipment as per written procedures.
• Authors solution preparation Master Batch Records (MBRs) by transferring technical information from scientific and development documents.
• Proposes and routes revisions to existing SOP’s for functional area equipment.
• Works to become proficient on common bioprocessing equipment.
• Participates in low risk deviations investigations. Assists in the implementation of Corrective Action / Preventative Actions (CAPA) action items within agreed upon timelines.
• Conducts Safety and GMP self-auditing walkthroughs, documenting observations for assignment and closure dates. Tracks and ensures closure of observations.
• Logs and submits samples in Laboratory Information Management System (LIMS); tracks results and compiles data.
• Reviews own work for completeness on executed Master Batch Records (MBRs).
• Coordinate the tracking and return of executed records to Quality department for review.
• Coordinates with Logistics to ensure needed materials are delivered to the production area timely. Monitors future needs against material supply to alert Logistics of shortfalls.
• Performs other tasks and assignments as needed and specified by management.

Qualifications:

• Bachelor’s degree in science or engineering with a 0 – 5 years relevant experience or an associate’s degree in science or engineering with a minimum of 3 years relevant experience or a high school diploma with a minimum of 7 years relevant experience.
• Demonstrated ability to follow written instructions and procedures.
• Demonstrated ability to pay strict attention to detail.
• Proficiency with Microsoft Office.
• Excellent verbal and written communication and skills.
• Ability to work collaboratively as part of a team, in a fast-paced, matrixed, team environment consisting of internal and external team members. 

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