Pilot Plant Senior Manager

2 weeks ago

Vancouver, British Columbia, Canada AbCellera Full time
About the Role

We are seeking a highly motivated and experienced professional to join our team as a Pilot Plant Senior Manager. In this role, you will provide technical and strategic leadership as we design, implement and operationalize a 200L scale pilot manufacturing facility to generate material for CMC development.

This will involve providing technical and scientific expertise and leadership for process optimization, scale-up, technology transfer and troubleshooting. You will also provide scientific leadership and project management for multiple early stage development projects.

Key Responsibilities
  • Provide strategic, technical and tactical leadership within the manufacturing, science & technology team through oversight of a 200L scale pilot manufacturing facility
  • Provide technical and scientific expertise and leadership for process optimization, scale-up, technology transfer and troubleshooting
  • Provide scientific leadership and project management for multiple early stage development projects
  • Champion high safety standards within the pilot plant
  • Detailed planning, coordination, implementation, tracking and communication to ensure material delivery whilst maintaining the production schedule for all technical pilot plant operations
  • Taking ownership and responsibility for the successful completion (as measured by product yield, quality & consistency, and the achievement of project timelines) of manufacturing campaigns
  • Provide a science-based approach for the evaluation and testing of new technologies / equipment to reduce cost of goods and streamline process development and manufacturing
  • Implement and oversee a robust equipment management and maintenance system, including oversight of and interaction with the site based support functions including the facility engineering and metrology teams
  • Oversee supply chain needs of the pilot plant, including working with materials management on ensuring critical supplies are available and in stock as well as, being the point person for new equipment or supplies required for new technology transfers into the pilot plant
Requirements
  • 8-12 years of industrial experience in process development, manufacturing, and/or MSAT, ideally working with antibodies, and a minimum of 4 years in a leadership role
  • Bachelor's or Master's education in biotechnology, chemical/biochemical engineering, or another relevant life-science discipline
  • Experience in scale-up, technology transfer, batch documentation and data management
  • Demonstrated experience in leadership and managing direct reports including, developing and training teams to operate pilot scale manufacturing equipment
  • Strong pilot-scale process and product data analysis skills, and practical experience for the establishment of processes and procedures for driving new investigational medicinal products forward
  • Familiarity with regulatory requirements as it pertains to CMC activities for biologics (FDA, EMA, ICH, etc). Experience authoring regulatory filings such as INDs, BLAs, IMPDs etc. would be advantageous
  • Passion for developing people and teams, and a proven track record establishing process development and/or manufacturing capabilities
  • Thrives in a fast-paced environment with a high level of urgency and evolving priorities, and applies pragmatic, risk-based decision making to process development and manufacturing
About AbCellera

AbCellera is a global company that discovers and develops antibody-based medicines that help people live longer, happier, and more productive lives. We are focused on bringing innovative medicines to patients, both by advancing our internal pipeline of programs and partnering with companies that have novel science or innovative technology.

We look for people with drive and energy. Idealists. People we love and people we trust. This may be unconventional, but it is the key to our success.

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