Job Scope:

The Technician/Specialist, Bioprocess – Upstream Processing will work within the Upstream Processing group and performs the following activities while executing upstream operations:

• Preparation of stock solutions, buffers and media.
• Filtration of stock solutions, buffers and media.
• Set-up and operate disposable fermenters / bioreactors and other disposable bioprocess equipment including depth filtration.
• Passage and expansion of microbial and mammalian cell lines
• The Technician/Specialist, Bioprocess – Upstream Processing supports relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate. 
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• Essential 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.