HyperMabs Inc. is a fast-growing biotechnology company focused on research and development of novel treatments for diseases with high unmet medical need. The team uses cutting-edge protein engineering technologies to achieve its mission of discovering new medicines with transformative potential.
The Director of Process Development will organize and oversee the strategic planning, optimization, and scaling of upstream and downstream manufacturing for recombinant protein-based therapeutics. This role involves managing and mentoring a team of professionals responsible for the operation of an R&D laboratory exploiting CHO cell culture and purification sciences platform to support process development for the production of clinical-stage recombinant protein candidates. The Director will also guide the technology transfer process to selected CDMOs operating under cGMP, ensuring the implementation of robust, scalable processes, aligned with Quality by Design (QbD) principles and regulatory standards. The incumbent will utilize the best scientific, industrial, and regulatory practices to promote platform and process innovation, support regulatory submissions, and facilitate successful clinical manufacturing campaigns.
This full-time position reports to the VP of Manufacturing and is based in Montreal, QC, Canada.
Key Responsibilities:
- Organize, manage and mentor a team of professionals responsible for conducting process development, process technology transfer to and scale up at CDMOs in support of the production of recombinant proteins to supply non-clinical and clinical studies.
- Lead the strategic design and optimization of seasoned manufacturing processes, including CHO cell line development, ensuring alignment with company strategy, cost of goods (COGS), Quality by Design (QbD) principles and regulatory expectations.
- Oversee the planning and approval of experimental designs and study protocols, ensuring scientific rigour and alignment with organizational goals.
- Provide leadership, mentoring and guidance for protocol execution, data analysis, and technical reporting, ensuring consistency, accuracy, and timely delivery across the process development team.
- Ensure operational excellence in manufacturing sciences, including oversight of equipment maintenance, capital planning, and resource allocation.
- Direct technology transfer and scale-up activities to cGMP contract development & manufacturing organizations (CDMOs), ensuring seamless knowledge transfer ensuring process fidelity.
- Promote timely process improvement initiatives, focusing on robustness, control strategies, comparability and cost of goods (COGs) optimization.
- Review and approve manufacturing documentation and regulatory submissions to ensure technical accuracy and strategic alignment with regulatory requirements.
- Provide cross-functional technical leadership during manufacturing, including oversight of investigations on non-conformities and implementation of corrective actions.
Qualifications:
- Advanced degree (Ph.D. or M.Sc.) in Biochemistry, Biotechnology, Biochemical Engineering, or related discipline; exceptional candidates with a B.Sc. and extensive leadership experience may be considered.
- Minimum 10+ years of experience in biopharmaceutical process development and production, with a strong focus on recombinant protein production and clinical-stage programs supply.
- Proven leadership in upstream and downstream process development, scale-up and technology transfer, including CHO cell line development, bioreactor operations from bench to cGMP commercial scales.
- Experience with scale-down models, design of experiments (DOE), and statistical analysis tools to support process characterization and validation.
- Experience with the design of viral clearance studies in accordance with ICH guidelines.
- Deep understanding of GMP and global regulatory requirements (e.g., Health Canada, FDA, EMA, MHRA) for manufacturing of biologics API.
- Expertise in industrial expression systems and upstream technologies, including perfusion and fed-batch strategies for recombinant protein production.
- Expertise in Downstream process technologies (e.g., chromatography, depth filtration, nanofiltration, tangential flow filtration) for recombinant protein production.
- Demonstrated ability to lead cross-functional teams and collaborate effectively with internal stakeholders and external partners (e.g.: CDMOs).
- Strong problem-solving and decision-making skills, with a track record of resolving complex technical challenges in development and manufacturing environments.
- Excellent communication and leadership skills, with the ability to influence strategy, mentor teams, and represent the company in regulatory and partner interactions.
Contact
Please send your CV and cover letter outlining your motivation and relevant experience for the role to [email protected] quoting “HyperMabs Posting DPD0506” in the subject line – we are looking forward to hearing from you!
HyperMabs Inc. is an equal opportunity employer and encourages applications from persons of any race, religion, ethnicity, gender identity, sexual orientation, age, immigration status, disability, or other legally protected characteristics.
We thank all applicants for their interest, however, only those under consideration will be contacted.
Benefits:
- Commuter benefits
- Dental care
- Disability insurance
- Employee assistance program
- Extended health care
- Flexible schedule
- Life insurance
- Paid time off
- Vision care
- Wellness program
Experience:
- biopharmaceutical process development and production: 10 years (required)
Location:
- Montréal, QC H2Y 2Z4 (preferred)
Work Location: In person
