Technical Group Leader, Upstream Manufacturing - Biologics - Eurofins CDMO Alphora, Inc
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- Mississauga, ON
- Permanent
- Temps-plein
- Serve as the primary technical point of contact for transferring upstream processes from PD into GMP manufacturing.
- Execute and oversee small- and pilot-scale upstream PD experiments, including seed expansion, buffer preparation, and bioreactor operations (benchtop & large-scale SU).
- Lead technology transfer, scale-up designs, experimental protocols, and scientific reporting.
- Operate and maintain key upstream equipment: SU bioreactors, shaker incubators, cell counters, peristaltic pumps, mixers, and more.
- Perform upstream experiments, harvests, depth filtration, and sterile filtration.
- Apply expert aseptic techniques in all cell culture activities.
- Lead authoring of batch records, SOPs, equipment qualifications, and CQV protocols.
- Ensure accurate documentation of all raw data (GDP/GLP), interpret results, and propose next-step experimentation.
- Keep facility and equipment logbooks compliant with SOPs and cGMP standards.
- Lead RCA investigations for process deviations and own CAPA development and execution.
- Drive improvements in process robustness, operational efficiency, and data quality.
- Partner closely with QA, QC, DS Processing, and other Biologics teams to ensure smooth material flow and testing.
- Support downstream operations, buffer prep, and other groups as needed.
- Oversee GMP upstream manufacturing activities and supervise floor operations.
- Act as the suite's safety officer, ensuring safe, compliant equipment handling and PPE/ergonomic standards.
- Maintain an always-inspection-ready environment, serving as an SME during audits and tours.
- Oversee ordering of materials, consumables, and equipment.
- Coordinate calibration, PMs, and equipment readiness for all upstream unit operations.
- Participate in suite cleaning and changeovers per CL2 and cGMP guidelines.
- Strong technical expertise in mammalian cell culture and upstream bioprocessing.
- Experience with scaling processes from benchtop to pilot/GMP manufacturing.
- Excellent problem-solving, documentation, and leadership abilities.
- Passion for hands-on science and guiding team members through complex activities.
- MSc or BSc in chemical/biochemical/bioprocess engineering or similar with minimum of five (5) years of industry experience is required.
- Demonstrated experience in upstream bioprocessing (in biologics).
- Experience in managing, supervising, and/or leading a team of technologists is a requirement.
- Experience in technology transfer is a requirement.
- Experience in SOP drafting and previous involvement in GMP runs is a requirement.
- Strong interpersonal skills and ability to work collaboratively as a member of a cross-functional team.
- Excellent communication, GMP documentation, and organizational skills.
- Strong problem-solving skills