Senior Director, Manufacturing Operations Lead

1 month ago

Vancouver, British Columbia, Canada https:www.energyjobline.comsitemap Full time
About the Role

We are seeking a highly experienced Senior Director, Manufacturing Operations to lead the design, construction, and operation of a new GMP manufacturing facility for the production of antibody therapeutics. As a key member of our team, you will be responsible for building a team and designing facilities to meet our audacious goal of going from discovery to fill-finish in a year.

You will be given the freedom to innovate and move at lightning speed to create a legacy in our industry. Your expertise in manufacturing operations, process development, and GMP compliance will be essential in building and managing the new GMP facility.

Key Responsibilities
  1. Providing exceptional leadership to the organization, including hiring, mentoring, and developing staff.
  2. Serving as the senior manufacturing operations leader for the design, construction, and start-up of a new GMP Manufacturing facility for the production of antibody therapeutics.
  3. Working closely with site leadership and quality peers to develop and implement all GMP systems with an emphasis on paperless eSystems.
  4. Working closely with TechOps peers in process & analytical development to establish a paradigm for efficient process transfer and for SME technical support to manufacturing.
  5. Ensuring the schedules of the people, facility, equipment, materials, and documents are established and maintained to support the throughput of the facility.
  6. Identifying and mitigating risks in manufacturing operations that could negatively impact delivery of safe and effective therapies to patients.
  7. 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.
  8. Reviewing and approving controlled master documents including standard operating procedures, batch records, material specifications, and validation protocols.
  9. Budgeting and planning including working closely with the Business Development team to support establishment of global partnerships for antibody discovery-through-GMP.
Requirements
  1. You are strongly self-motivated and are able to identify project needs and follow that up with building and implementing solutions.
  2. You are passionate about building dynamic new teams and capabilities that accomplish important goals.
  3. You have a BS/MS/PhD in biological sciences, engineering or relevant scientific discipline and 12-15+ years of experience in manufacturing of biologics in a GMP setting.
  4. You have 6+ years of experience in a leadership role managing technical operations, process development, and/or GMP manufacturing operations.
  5. You have outstanding technical acumen, operational understanding, and GMP compliance in building and managing the new GMP facility.
  6. You have the passion to build, lead, and mentor a team with the opportunity to leave a lasting legacy on the team, the organization, and the country.
  7. You have a desire to innovate and push to do things differently.
  8. You are enthusiastic about applying your expertise in manufacturing operations.
  9. You are an outstanding communicator and teammate.
  10. You have experience leading a site through quality audits and/or regulatory inspections and also have experience with CMC regulatory filings.
What We Offer

AbCellera's hiring range for this role is CAD $190,000 - $235,000 annually, commensurate with your education and job-related knowledge, skills, and experience. In addition to base salary, we offer equity, annual bonus dependent on team and company performance, and a 6% (non-match) RRSP contribution.

You will have a 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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