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

We are searching for an experienced and hands‑on Technical Group Leader, Downstream Manufacturing to join our growing Manufacturing Operations team. Reporting to the Manager, Downstream Processing, you will play a critical role in ensuring operational readiness and ongoing compliance of our cGMP manufacturing suites.

In this leadership-focused, highly technical role, you will guide the execution of downstream unit operations—chromatography, UF/DF, filtration, and protein bioconjugation—while driving the successful transfer of processes from Development into GMP manufacturing.

The ideal candidate thrives in a fast‑paced environment, excels at mentoring and directing manufacturing teams, and has deep expertise in downstream biologics processing, equipment operation, and GMP principles. You will be instrumental in enabling the production of high‑quality clinical and commercial materials.

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 Do

As the Downstream Manufacturing Technical Lead, you will combine hands-on execution with strategic oversight to ensure flawless cGMP operations:

Technical & Operational Leadership

• Serve as the primary technical point of contact for transitioning processes from Process Development (PD) into the GMP manufacturing suite.
• Oversee and lead all downstream GMP activities, including floor supervision during manufacturing operations.
• Plan, stage, and execute downstream experiments and manufacturing runs with precision and efficiency.
• Lead technical investigations, perform root‑cause analysis, and author comprehensive deviation reports and CAPA plans.
• Ensure downstream areas are inspection‑ready at all times and act as an SME during internal audits and regulatory inspections.

Downstream Processing Expertise

• Execute core downstream operations:
  • Chromatography (AKTA, skid systems)
  • Tangential Flow Filtration (TFF/UF‑DF)
  • Depth and nanofiltration
  • Chemical conjugation of proteins
  • Buffer preparation
• Operate and maintain chromatography skids, TFF skids, filtration systems, and related equipment.
• Perform in‑process sampling and basic analytical testing.
• Apply strong aseptic technique throughout all processing steps.

Documentation, Compliance & Quality

• Write, review, and support authoring of batch records, SOPs, and equipment qualification documents.
• Lead or support commissioning, qualification, and validation (CQV) protocol authoring and execution.
• Ensure all data and documentation follow GDP/GLP standards with meticulous accuracy.
• Maintain complete facility and equipment logbooks in accordance with SOPs.

Cross‑Functional Collaboration & Leadership

• Coordinate closely with Upstream Processing, QA, QC, and Raw Materials teams for seamless material handoffs and timely testing.
• Order raw materials, consumables, and equipment; oversee equipment calibrations and preventative maintenance.
• Participate in suite cleaning and changeovers to maintain CL2 and cGMP standards.
• Serve as the primary safety officer in the suite, ensuring proper PPE, ergonomics, and biohazard waste handling.
• Train, mentor, and support junior manufacturing staff by modeling best practices and providing clear direction.

Why Work Here

Joining our team means stepping into a leadership role where your expertise has direct, meaningful impact on producing life‑changing therapeutics. Here’s what sets this opportunity apart:

⭐ Lead High‑Impact GMP Operations

You’ll be at the center of downstream manufacturing for cutting‑edge biologics—playing a pivotal role in delivering high‑quality clinical materials.

⭐ Shape the Future of Bioprocessing

From tech transfer to CQV to process scale‑up, you will influence how new processes are implemented and optimized.

⭐ Work With Advanced Technologies

You’ll operate state‑of‑the‑art purification and filtration systems while gaining exposure to innovative protein bioconjugation workflows.

⭐ Grow as a Technical Leader

This role offers mentorship opportunities, SME responsibilities, and direct involvement in investigations and regulatory interactions.

⭐ Collaborative, Science‑Driven Culture

Work alongside experienced scientists and engineers who value teamwork, continuous improvement, and operational excellence.

⭐ A Commitment to Quality & Compliance

You’ll be part of an organization that prioritizes safety, data integrity, and accountability—creating a strong foundation for success.