Technical Group Leader, Upstream Manufacturing - Biologics - Eurofins CDMO Alphora, Inc.

Drive Innovation. Lead Science. Shape the Future of Biologics.

Are you ready to lead upstream innovation that directly drives successful GMP manufacturing? As our Technical Group Leader – Upstream, you will play a pivotal technical and leadership role within our Biologics Business Unit, guiding upstream process development from small-scale experiments to pilot-scale operations and technology transfer into GMP.

In this hands-on, high-impact role, you will mentor and lead technical activities, oversee cell culture operations, design scale‑up strategies, and ensure seamless transition of processes into the manufacturing suite. If you thrive at the intersection of science, operations, and leadership—this is your opportunity to make a measurable difference.

The Technical Group Leader-Upstream is accountable for executing and reporting on upstream activities, including execution of small/pilot scale PD and scale-up experiments within the Biologics Business Unit to meet the business objectives. Our carefully selected candidate will play a crucial role for cell culture PD, which includes handling of various mammalian cell lines during seed expansion, operation of benchtop and large-scale single use (SU) bioreactors, and conducting harvesting for both depth and sterile filtration systems. In addition to hands-on laboratory activities, the ideal candidate will be involved in technology transfer, scale-up design, and writing experimental reports/protocols.

At Eurofins CDMO Alphora Inc., our mission is to harness the power of biotechnology and bioprocessing to create innovative complex medicines that will improve the lives of patients worldwide. With a dedicated team of experienced scientists, motivated technologists, and state-of-the-art process development (PD) facility, we are thrilled to be at the forefront of the biopharmaceutical CDMO industry in Canada. Join us on this exciting journey as we push the boundaries of scientific research and provide hope to our most vulnerable

 What You’ll Lead & Deliver

You will drive upstream activities that support process innovation, operational excellence, and successful clinical/commercial production and you will take ownership of:

Technical Leadership & Process Development

• 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.

Hands-On Upstream Operations

• 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.

Documentation, Compliance & Technical Writing

• 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.

Investigation & Continuous Improvement

• Lead RCA investigations for process deviations and own CAPA development and execution.
• Drive improvements in process robustness, operational efficiency, and data quality.

Cross-Functional Collaboration

• 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.

GMP Operations & Suite Leadership

• 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.

Materials, Equipment & Suite Readiness

• 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.

What Makes You a Great Fit

• 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.

Why This Role Matters

Your leadership will directly influence the success of upstream process development and the transition of life‑changing biologics into GMP manufacturing. This is a unique opportunity to combine scientific depth, operational leadership, and cross-functional impact.