Purification Process Expert
1 week ago
AbCellera is seeking a highly skilled and experienced Senior Manager, Downstream Site Operations to join our team. As a subject matter expert in purification processes, you will play a key role in process and facility design, driving technology transfer, process controls, recipe and batch record development, technical troubleshooting, and successful batch production in our new GMP manufacturing facility.
Key Responsibilities- Provide technical leadership as the subject matter expert for the purification of monoclonal and/or bispecific antibodies.
- Act as the key receiver during technology transfer of new processes from process development and pilot plant operations, enabling scale-up, risk management, recipe development, batch record development, and overall engineering run and drug substance success.
- Work closely with the 200L scale pilot plant operations team to prepare process risk assessments, raw material risk assessments, control strategies, and technology transfer documentation.
- Contribute to process and facility design to enable best practices by design.
- Provide technical support to enable bioprocessing decisions in manufacturing, championing best for process principles together with quality and manufacturing.
- Design manufacturing systems that are technically sound, promoting effective and efficient operations, and compliance with cGMP requirements.
- Identify opportunities in GMP appropriate technologies with a vision of improving processing time, yield, cost of goods, and operational complexity.
- 8+ years of industry experience in the development and manufacturing of monoclonal and/or bispecific antibodies and a bachelor's degree in biotechnology, biochemistry, chemical engineering, molecular biology, or a similar discipline.
- Outstanding technical acumen in purification processes, including chromatography, tangential flow filtration, depth filtration, mixing, column packing and maintenance, viral inactivation, and viral filtration.
- Significant knowledge of downstream processing methods to support pre-clinical and clinical programs, and a strong understanding of GMP compliance.
- Experience in technology transfer and scale of monoclonal antibody processes from pilot to GMP scale.
- Passionate about building dynamic new teams and capabilities that accomplish important goals.
- Creative and innovative thinker, with the ability to identify potential issues before they arise.
- Strong sense of operational acumen and risk management, and can prioritize science and engineering approaches to prevent process downtime.
AbCellera's hiring range for this role is CAD $92,000 - $115,000 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, opportunity for flexible work arrangements, 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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