BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for an Upstream Supervisor to work for a leading San Diego biotechnology company.
Someone to lead the upstream activities for the manufacturing of clinical and commercial products. Executes pre and post processing activities such as:
- Buffer preparation,
- Set-up, operation, and cleaning the of single-use bioreactors (sizes up to 500L), and
- Harvest and clarify the conditioned medium.
Assist in the writing of SOP, material specifications, and manufacturing batch records. This position is accountable for executing the manufacturing processes in the cGMP Facility.
- Supervision of manufacturing processes and personnel.
- Coordinate with other production personnel to execute production campaigns on-time.
- Ensure batches adhere to established Quality standards.
- Provide daily production updates to management.
- Operate manufacturing equipment in assigned area.
- Ability to work with bioreactor operation and cell culture including aseptic technique.
- Demonstrate ability to perform all process steps upstream and/or support production operations.
- Execute and monitor critical processes supporting mammalian bioprocesses.
- Interpret process trends and data and react appropriately to unexpected outcomes.
- Provide guidance for continuous improvement initiatives with Upstream team.
- Provide suggestions for process optimization and efficiency, where applicable.
- Assist Facilities and Engineering personnel as necessary on equipment maintenance and calibration.
- Represent the department on cross-functional project teams.
- Provide support to cross-functional teams to meet production or timeline demands.
- Ensure the completeness and accuracy of manufacturing documentation per approved procedures.
- Support cGMP batch record review and close-out with the Quality Assurance group.
- Identify and support the implementation of process efficiencies and areas for improvement.
- Provide input for hiring new manufacturing associates and conduct interviews.
- Conduct performance reviews of manufacturing associates.
- BS Degree - Life Sciences or Chemical Engineering and 5 to 7 years in GMP environment with experience in GMP production including aseptic processing.
- Solid experience with the following: autoclaves, single use mixers, and single use bioreactors including the Wave bioreactor systems.
- Good mechanical aptitude. Detail oriented.
- Must be highly motivated, follow oral and written instructions, communicate effectively, think logically, and thrive independently and/or in a fast-paced team environment.
- Must be proficient in Word and Excel.
- Innovative spirit, strong initiative and work ethic, and positive attitude.
- Ability to work flexible hours and inconsistent schedules as necessary to meet production demands and timelines.
- Able to follow written instructions and document work performed.