QC Analyst II

Performing analytical testing with a high level of accuracy and precision, using techniques such as UPLC, CE-SDS, icIEF, ELISA, qPCR, UV-Vis, and other separation, immunochemical, and compendial methods, in accordance with GMP requirements, compendial standards, and internal SOPs

Planning and executing release, stability, in-process, and raw material testing, including time-critical samples and raw material sampling, in alignment with manufacturing and program timelines

Developing, optimizing, verifying, and supporting qualification of GxP analytical methods for drug substance (DS) and drug product (DP) samples, ensuring methods are fit for purpose and meet specifications and regulatory expectations

Participating in method transfers, qualifications and validations, method comparisons, and stability studies, including protocol execution, data review, and report support

Evaluating and reviewing analytical data for conformance to approved methods, specifications, and acceptance criteria, and escalating suspect or atypical results

Troubleshooting analytical and laboratory issues, supporting investigations, identifying root cause, and implementing corrective and preventive actions

Supporting equipment and reagent selection, qualification, maintenance, and calibration, and contributing to ongoing GMP facility readiness and laboratory process development

Authoring and revising work instructions, SOPs, test methods, protocols, reports, and other controlled QC documentation

Collaborating with formulation development, analytical development, process development, manufacturing, quality assurance, and regulatory affairs to support the development, manufacture, release, and stability of high-quality therapeutics

Assisting in training and mentoring junior analysts on analytical techniques, laboratory procedures, data integrity, and GMP expectations

You have a Bachelor's degree with 5+ years of QC experience, or a Master's degree in a relevant scientific discipline with 3+ years of QC experience

You have strong knowledge of GMPs, data integrity expectations, analytical QC testing, and method qualification/validation requirements

You have hands-on experience with analytical techniques such as UPLC, CE-SDS, icIEF, qPCR, UV-Vis, and related compendial or physicochemical methods, as well as immunochemical methods such as ELISA (experience with cell-based methods is an asset)

You have experience working with laboratory data systems such as LIMS and chromatography data systems (experience with Empower is an asset)

You troubleshoot analytical methods and instruments with confidence, evaluating atypical results and applying sound scientific judgment and root cause analysis

You are detail-oriented, organized, and methodical, and you work well both independently and as part of a team

You communicate clearly in writing and in conversation, and you are comfortable authoring controlled GMP documentation and working across functions

We are a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology, women’s health, immunology, and oncology. We have built a platform for advancing antibody drug programs from target to clinic, and we are using it to build our internal pipeline. Today, our pipeline includes two drug candidates in clinical development, two preclinical development candidates (DCs) in Investigational New Drug (IND)-enabling activities, and more than 20 active discovery programs across multiple modalities and indications.

We believe that when tenacious people share a vision and work together, they can truly have a positive impact. That’s why we hire for character and intelligence, not just for CVs or experience.

We look for people with drive and energy. People we trust. People who need to know their days are being well spent. That their work really matters. In the end, our success will be measured by the impact of our medicines.

Please submit your application through our website and refer to Job ID 23410 in your cover letter. We receive a large volume of applications and are only able to contact those who are selected for an interview. All communication from our Talent Discovery team will come from an @abcellera.com email address.