Associate Scientist, Formulation Development

AbCellera•Vancouver, BC

2d•CA$64,000 - CA$80,000

About The Position

We are looking for an Associate Scientist to join our Formulation and Drug Product Development (FDPD) team within Pharmaceutical Science at AbCellera, to help us shape how our antibody therapies move from the bench toward patients. In this role, you will get hands-on exposure across the full FDPD landscape, from drug substance (DS) and drug product (DP) development to technical transfer support. You’ll play a direct role in building out our internal DP development capabilities for monoclonal antibody formulations, and design the workflows and documentation that make successful fill-finish operations possible.

Requirements

The equivalent of 2+ years of industry experience, in addition to a Bachelor’s or Master’s degree
Experience with protein formulation, stability, and biophysical characterization for liquid or lyophilized drug products
A strong understanding of how process parameters, equipment, raw materials, scale, site differences, and process-related stresses can impact product quality
Familiarity with various analytical techniques for characterizing biopharmaceuticals (e.g., liquid chromatography, capillary electrophoresis, and/or spectroscopy-based methods)
A working knowledge of electronic lab notebooks (e.g., Benchling), and with 21 CFR Part 11 compliance requirements
Strong organizational, data management, and time management skills, with excellent attention to detail

Responsibilities

Supporting pre-formulation and formulation development studies for antibody-based drug products, including buffer preparation, sample handling, and testing
Performing forced degradation, thermal, freeze-thaw, agitation, and photostability studies to assess formulation robustness and identify degradation pathways
Drafting standard operating procedures, work instructions, and preparing study protocols
Designing, executing, and monitoring stability studies, including sample preparation and pulling per protocol, coordinating testing, compiling and trending data, and supporting investigation of atypical or out-of-trend results
Supporting small-scale fill-finish activities, including fill volume and overfill determination, filtration and mixing studies, and in-process sampling
Conducting and interpreting biophysical and analytical characterization studies using a range of analytical methods, including SEC, IEX CE-SDS, DSC, DLS, UV-Vis concentration, sub-visible particles, turbidity and appearance, viscosity, osmolality, pH
Compiling data into reports or presentations and effectively communicating technical results clearly to diverse audiences
Maintaining accurate, contemporaneous records in ELNs in accordance with data integrity expectations and Good Documentation Practices
Performing routine laboratory operations: instrument qualification support, calibration and maintenance, reagent and buffer preparation, inventory management, and lab safety compliance