(Senior) QC Analyst
AbCellera is an energetic, and rapidly growing tech company with an amazing team that searches, decodes, and analyzes natural immune systems to find antibodies that its partners can develop into drugs to prevent and treat disease. Working at the interface of computation, engineering, and biology, AbCellera is rebuilding the front-end process of how drugs are discovered with a discovery platform that integrates modern technologies from engineering, microfluidics, single-cell analysis, high-throughput genomics, machine learning, and hyper-scale data science. With over 600 AbCellerites and growing, we’re expanding our capabilities to include Process Development and Clinical Manufacturing of antibodies to bring therapies from idea to patients, faster.
As a part of our newly created CMC organization, you will support our new process development platform from the ground up, all while leveraging cutting-edge technologies. You will be part of a team with an audacious goal: to go from discovery to fill-finish in a year.
We are seeking a highly skilled and experienced analytical biochemist to join our quality control team as a (Senior) QC Analyst. You will be responsible for lab start up procedures, executing experiments, conducting analyses, troubleshooting methods, and ensuring compliance with regulatory requirements.
We’d love to hear from you if
- You are an innovator and ready to help new approaches to the discovery and development of therapeutics
- You have a strong desire to support early antibody discovery work by developing ways to improve and speed up the discovery to CMC development to GMP manufacturing paradigm
- You have a strong background in separation techniques and purity analysis
- You have strong knowledge of analytical chemistry principles and methods
- You are highly motivated and excited about the opportunity to work with an inspired team on challenging problems that matter
How you might spend your days
- Supporting and leading lab start up procedures including but not limited to; equipment selection/qualification, material/reagent selection, method development/review, documentation, training and process development
- Performing and overseeing, with a high level of accuracy and precision, various analyses such as UPLC, CE-SDS, icIEF, SEC and other separation and compendial techniques in accordance with FDA, USP, ICH and internal SOPs
- Developing and optimizing GxP methods to analyze drug substance (DS) and drug product (DP) samples, ensuring they meet required specifications and regulatory standards
- Troubleshooting and resolving issues that arise during analysis, identify true root cause and implement corrective actions
- Supporting maintenance and calibration laboratory instruments and equipment, ensuring their proper functioning and adherence to standard operating procedures
- Collaborating with cross-functional teams, including formulation, upstream manufacturing, process development, and regulatory affairs, to support the development and release of high-quality therapeutics
- Participating in method transfers, method validations, method comparisons, and stability studies
- Ensuring compliance with all relevant health, safety, and environmental regulations, as well as Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) guidelines
- Assisting in training and mentoring junior analysts, providing guidance on separation techniques and laboratory procedures
Required qualifications and experience
- Bachelor’s or Master’s Degree in Chemistry, Biochemistry Pharmaceutical Sciences, or a related field
- 4-5+ years experience working in GMP QC Laboratory with a focus on some or all of the following analytical techniques:
- High Performance Liquid Chromatography (HPLC) or Ultra Performance Liquid Chromatography (UPLC) with Empower.
- Purity analysis (SEC, icIEF, CE-SDS).
- UV Spectroscopy.
- N-glycans analysis.
- Peptide Mapping.
- Proven experience working in a DP/DS quality control laboratory, preferably in a GMP regulated environment (pharmaceutical, biotechnology, or related industry)
- Strong knowledge of analytical chemistry principles, instrument operation, and data interpretation
- Experience with compendial testing such as pH, Osmolality, Turbidity, Appearance in accordance with current USP/JP/EP
- Hands-on experience with method development, method validation, and method transfers
- Experience with authoring/reviewing non-conformances such as quality events, deviations, OOS/OOT investigations and associated CAPA’s
- Familiarity with regulatory guidelines, including ICH and FDA guidelines.
- Strong experience with various software/databases such as, but not limited to MES, eQMS and LIMS
- Experience with QC lab/manufacturing facility start-up is an advantage
What we offer
A generous compensation package including an equity stake in AbCellera’s success. Our headquarters are nestled in the heart of Vancouver, Canada - we’ll support you and your family in every way we can to relocate if you haven't had the joy of living in this beautiful area!
At AbCellera, we find the next generation of therapeutic antibodies. To succeed, we have created innovative solutions at every step - custom antigen preparation and immunizations, microfluidics, high-throughput imaging, genomics, computation, machine learning and laboratory automation - leaving no stone unturned and revolutionizing how scientists can explore natural antibody diversity and the scale at which they can do it. You’ll join a diverse and multi-disciplinary team of biologists, biochemists, engineers, bioinformaticians, computer scientists and physicists - all working together to bring better therapies to patients. This is life-changing research and you could be a part of it.
We’re a growing company with state-of-the-art discovery tools and the drive to be the best in the industry. This isn’t just about having the best technology. We know we need a world-class team of innovators working together to solve the toughest problems. 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. We’re looking for someone like you to support and organize our efforts along the way.