QC Scientist II/III
Abzena Inc.
Summary
The Scientist III is an experienced analytical scientist who independently executes complex method development, qualification, and analytical testing activities. This role contributes significantly to technical problem-solving and provides mentorship to junior team members.
Job description
Responsibilities
- Independently design and execute complex analytical methods within the assigned platform(s).
- Lead method qualification activities and prepare qualification protocols and reports.
- Perform routine and non-routine analytical testing in support of ongoing projects; analyze, interpret, and present data.
- Author and review SOPs, test methods, and technical/qualification documentation; maintain accurate GMP records.
- Support OOS investigations and contribute to CAPA implementation.
- Provide guidance and mentorship to Scientist I/II and Associate staff; collaborate cross-functionally and communicate technical updates.
- Independently perform and coordinate routine/non-routine GMP and stability testing; verify method, sample, and instrument readiness and escalate atypical results or testing-window risks.
Qualifications
- Bachelor's or Master's degree in Analytical Chemistry, Biochemistry, or related field.
- 5–7+ years of experience in analytical method development and testing.
- Strong background in the assigned platform(s) (HPLC, CE, GC, or compendial assays).
- Experience working in a GMP environment; track record of independently leading method development or qualification activities.
- Stability testing: Independently executes stability timepoints according to approved protocols and testing windows, confirms sample and method readiness, reviews data for consistency/trends, and promptly escalates atypical or potentially reportable results.
- Method lifecycle and investigations: Leads defined qualification activities, authors protocols/reports and test methods, supports transfers and method changes, and provides substantive technical input to OOS/Laboratory Investigations and CAPAs.
Requirements
- Bachelor's or Master's degree in Analytical Chemistry, Biochemistry, or related field
- 5–7+ years of experience in analytical method development and testing
- Strong background in assigned platform(s): HPLC, CE, GC, or compendial assays
- Experience working in a GMP environment
- Track record of independently leading method development or qualification activities
- Stability testing execution and data review
- Method lifecycle and investigations experience (OOS/Laboratory Investigations, CAPAs)
Company overview
Abzena Inc. is a leading biopharmaceutical Contract Development and Manufacturing Organization (CDMO) and Contract Research Organization (CRO) specializing in complex biologics and bioconjugates. Founded in 2001, the company provides fully integrated, end-to-end services spanning from discovery through commercial launch, with a particular focus on antibody-drug conjugates (ADCs), antibody-oligonucleotide conjugates (AOCs), and radionuclide-drug conjugates (RDCs). With over 20 years of scientific expertise, Abzena operates state-of-the-art research, development, and cGMP manufacturing facilities across strategic locations in San Diego, California; Bristol, Pennsylvania; and Cambridge, United Kingdom. The company employs 501-1,000 professionals and has developed proprietary technologies including ThioBridge™ conjugation technology, EpiScreen® immunogenicity assessment platform, AbZelectPRO™ cell line development system, and Composite Human Antibody™ deimmunization platform. Abzena serves biotech and biopharma companies by offering tailored solutions designed to de-risk and streamline drug development, accelerating the path to market for life-changing therapies while maintaining rigorous quality standards and regulatory compliance.