Technical Group Leader, Downstream Manufacturing - Biologics - Eurofins CDMO Alphora, Inc.
Eurofins CDMO Alphora Inc. is seeking an experienced and hands-on Technical Group Leader for Downstream Manufacturing to join our growing Manufacturing Operations team. Reporting to the Manager of Downstream Processing, this role is pivotal in ensuring the operational readiness and compliance of our cGMP manufacturing suites. Eurofins CDMO Alphora Inc. specializes in developing and manufacturing new therapeutics to improve patient health, offering contract research and development services to global pharmaceutical and biotech companies.
The Technical Group Leader will oversee and lead all downstream GMP activities, including floor supervision during manufacturing operations. Key responsibilities include planning, staging, and executing downstream experiments and manufacturing runs with precision and efficiency. The role also involves leading technical investigations, performing root-cause analyses, and authoring comprehensive deviation reports and CAPA plans. Ensuring that downstream areas are inspection-ready at all times and acting as a subject matter expert during internal audits and regulatory inspections are also critical aspects of this position.
Candidates must possess an MSc or BSc in chemical, biochemical, or bioprocess engineering, or a similar field, with a minimum of five years of industry experience. A strong working knowledge of FDA, Health Canada, and ICH guidelines related to cGMP manufacturing is essential. Experience in drafting standard operating procedures (SOPs) and previous involvement in GMP runs are required. Demonstrated experience in downstream bioprocessing within biologics, particularly in a leadership capacity, along with the ability to troubleshoot common downstream process steps, is crucial. Experience in managing, supervising, or leading a team of technologists, as well as in technology transfer and commissioning, qualification, and validation activities, is also required.
The starting annual base compensation for this position is $95,000 CAD. Eurofins offers excellent full-time benefits, including health and dental coverage, life and disability insurance, an RRSP with a 3% company match, paid holidays, and paid time off.
Joining Eurofins CDMO Alphora Inc. means becoming part of a company that values continuous investment in modern facilities, equipment, and instrumentation, providing a rich environment for employees to develop their technical skills and career paths. Our employees work closely with clients throughout the development process to achieve program objectives, fostering a collaborative and technologically challenging environment.