Senior Director of Manufacturing Operations
3 weeks ago
AbCellera is a global company that discovers and develops antibody-based medicines to help people live longer, happier, and more productive lives. We are seeking a motivated leader to join our team as the Senior Director, Manufacturing Operations (GMP). This role will be responsible for building a team and designing facilities to meet an audacious goal: to go from discovery to fill-finish in a year.
Key Responsibilities:- Design, construction, qualification, and operation of a new GMP manufacturing facility for the production of antibody therapeutics.
- Serving as the senior manufacturing operations leader for the design, construction, and start-up of a new GMP Manufacturing facility.
- Ensuring the facility is designed for the future, including the ability to implement innovative manufacturing approaches, add additional capacity, and/or extend into other competency areas.
- Working closely with site leadership and quality peers to develop and implement all GMP systems with an emphasis on paperless eSystems.
- Working closely with TechOps peers in process & analytical development to establish a paradigm for efficient process transfer and for SME technical support to manufacturing.
- Ensuring the schedules of the people, facility, equipment, materials, and documents are established and maintained to support the throughput of the facility.
- Identifying and mitigating risks in manufacturing operations that could negatively impact delivery of safe and effective therapies to patients.
- Providing senior leadership to ensure the facility and operation is prepared for all quality audits by AbCellera partners and regulatory inspections by global regulatory agencies and that any findings are addressed promptly.
- Reviewing and approving controlled master documents including standard operating procedures, batch records, material specifications, and validation protocols.
- Budgeting and planning including working closely with the Business Development team to support establishment of global partnerships for antibody discovery-through-GMP.
- BS/MS/PhD in biological sciences, engineering or relevant scientific discipline.
- 12-15+ years of experience in manufacturing of biologics in a GMP setting.
- 6+ years of experience in a leadership role managing technical operations, process development, and/or GMP manufacturing operations.
- Outstanding technical acumen, operational understanding, and GMP compliance in building and managing the new GMP facility.
- Experience leading a site through quality audits and/or regulatory inspections and also have experience with CMC regulatory filings.
- CAD $190,000 - $235,000 annually, commensurate with your education and job-related knowledge, skills, and experience.
- Equity, annual bonus dependent on team and company performance, and a 6% (non-match) RRSP contribution.
- CAD $1,500 annual Active Lifestyle Allowance, annual vacation, professional development opportunities, and comprehensive health benefits.
- Scientific and technical mentorship is a priority.
- And you'll find we prioritize teams and social groups to build community and connections across AbCellera.
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Senior Director of Manufacturing Operations
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Vancouver, British Columbia, Canada AbCellera Full timeAbout the RoleAbCellera is seeking a highly skilled and experienced Senior Director, Manufacturing Operations to lead the design, construction, and start-up of a new GMP manufacturing facility for the production of antibody therapeutics.This is a unique opportunity to join a dynamic team and make a lasting impact on the company's success. As a Senior...
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Senior Director of Manufacturing Operations
4 weeks ago
Vancouver, British Columbia, Canada AbCellera Full timeAbout the RoleAbCellera is seeking a highly skilled and experienced Senior Director, Manufacturing Operations to lead the design, construction, and start-up of a new GMP manufacturing facility for the production of antibody therapeutics.This is a unique opportunity to join a dynamic team and make a lasting impact on the company's success. As a Senior...
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