Bioprocess Specialist-Upstream Processing

Job Scope:

Position Information:

Worl Location: Pennington, NJ

Reports to: Senior Manager, Upstream 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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