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

Eurofins Voir toutes les offres

  • Mississauga, ON
  • Permanent
  • Temps-plein
  • Il y a 1 mois
Company DescriptionEurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.In over 35 years, Eurofins has grown from one laboratory in Nantes, France to 61,000 staff across a decentralised and entrepreneurial network of ca. 900 laboratories in 61 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.In 2025, Eurofins generated total revenues of EUR 7.296 billion, and has been among the best performing stocks in Europe over the past 20 years.Eurofins CDMO Alphora Inc. develops and manufactures new therapeutics to improve the lives and health of patients. Eurofins CDMO Alphora provides contract research & development services to global pharmaceutical and biotech companies, developing their processes and manufacturing their bulk drug substances (Active Pharmaceutical Ingredients -“API's”) as well as finished dosage products (tablets, capsules, suspensions) for supply to clinical trials and commercial requirements. Eurofins CDMO Alphora provides a rich and technologically challenging environment with a continuing flow of interesting projects. Our employees work in close concert with clients throughout the development process to achieve their program objectives. Eurofins CDMO Alphora Inc. is growing its state-of-the-art organization, with continued investments in modern facilities, equipment, and instrumentation while providing a rich environment for employees to develop their technical skills and careers paths.Job DescriptionWe 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 DoAs 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 HereJoining 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 OperationsYou'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 BioprocessingFrom tech transfer to CQV to process scale-up, you will influence how new processes are implemented and optimized.⭐ Work With Advanced TechnologiesYou'll operate state-of-the-art purification and filtration systems while gaining exposure to innovative protein bioconjugation workflows.⭐ Grow as a Technical LeaderThis role offers mentorship opportunities, SME responsibilities, and direct involvement in investigations and regulatory interactions.⭐ Collaborative, Science-Driven CultureWork alongside experienced scientists and engineers who value teamwork, continuous improvement, and operational excellence.⭐ A Commitment to Quality & ComplianceYou'll be part of an organization that prioritizes safety, data integrity, and accountability-creating 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 $95,000 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 applicant's experience, knowledge, skills, and abilities.Disclaimer: Salary information posted on sites other than the official careers page does not reflect the organization's 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 InformationAt 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 atWe 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

Eurofins