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

We are searching for an experienced and handson 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 operationschromatography UF/DF filtration and protein bioconjugationwhile driving the successful transfer of processes from Development into GMP manufacturing.

The ideal candidate thrives in a fastpaced 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 highquality 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 Youll 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 rootcause analysis and author comprehensive deviation reports and CAPA plans.
• Ensure downstream areas are inspectionready 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/UFDF)
  • Depth and nanofiltration
  • Chemical conjugation of proteins
  • Buffer preparation
• Operate and maintain chromatography skids TFF skids filtration systems and related equipment.
• Perform inprocess 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.

CrossFunctional 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 lifechanging therapeutics. Heres what sets this opportunity apart:

Lead HighImpact GMP Operations

Youll be at the center of downstream manufacturing for cuttingedge biologicsplaying a pivotal role in delivering highquality clinical materials.

Shape the Future of Bioprocessing

From tech transfer to CQV to process scaleup you will influence how new processes are implemented and optimized.

Work With Advanced Technologies

Youll operate stateoftheart 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 ScienceDriven Culture

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

A Commitment to Quality & Compliance

Youll be part of an organization that prioritizes safety data integrity and accountabilitycreating a strong foundation for success.

Qualifications :

• MSc or BSc in chemical/biochemical/bioprocess engineering or similar with minimum of five (5) years of industry experience is required.
• Strong working knowledge of FDA Health Canada and ICH guidelines that pertain to cGMP manufacturing.
• Experience in SOP drafting and previous involvement in GMP runs is a requirement.
• Demonstrated experience in downstream bioprocessing (in biologics) in a lead capacity along with demonstrated ability to troubleshoot common downstream process steps.
• Experience in managing supervising and/or leading a team of technologists is a requirement.
• Experience in technology transfer as well as commissioning qualification and validation activities 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.

The starting annual base compensation for this position is $95000 CAD. The actual offer reflecting the total compensation package plus benefits will be determined by a number of factors which include but are not limited to the applicants experience knowledge skills and abilities.

Disclaimer: Salary information posted on sites other than the official careers page does not reflect the organizations compensation and may represent estimated ranges provided by third-party job boards. The organization offers competitive wages and a comprehensive total rewards package which will be discussed during the interview process.

At Eurofins CDMO Alphora we leverage artificial intelligence (AI) technology to support our recruitment process including preliminary screening of applications and resumes. All hiring decisions are made by human reviewers.

This posting is for a current vacancy and the successful candidate will start as soon as possible.

Additional Information :

At Eurofins we offer excellent full-time benefits including health & dental coverage life and disability insurance RRSP with 3% company match paid holidays paid time off.

Accommodation: Persons with disabilities who need accommodation in the application process or those needing job postings in an alternative format may e-mail a request via the website at .

As a Eurofins employee you will become part of a company that has received international recognition as a great place to work. To learn more about Eurofins please explore our website at 

We thank all applicants within commuting distance of GTA Ontario for showing an interest in this position. Only those selected for an interview will be contacted.

NO AGENCIES CALLS OR EMAILS PLEASE

Remote Work :

No

Employment Type :

Full-time