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 HPLC, CE, GC, or compendial assays.
Experience in a GMP environment with a proven ability to lead method development or qualification activities.
Proficient in executing stability testing and managing data consistency.
Expertise in method lifecycle management and supporting investigations.
Responsibilities
Design and execute complex analytical methods independently.
Lead method qualification activities and prepare necessary documentation.
Conduct routine and non-routine analytical testing, analyzing and presenting data.
Author and review SOPs and maintain accurate GMP records.
Support OOS investigations and contribute to CAPA implementation.
Mentor junior scientists and collaborate across teams to communicate updates.
Coordinate GMP and stability testing, ensuring readiness and addressing atypical results.
Benefits
Mentorship opportunities for career growth.
Collaborative work environment with cross-functional teams.
Engagement in complex problem-solving activities.
Exposure to a variety of analytical platforms and methodologies.
Full Job Description
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.
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.
FLSA: Exempt
About Abzena plc
Abzena is a life sciences group with headquarters in Cambridge, UK and offices in the US and Japan. The company provides technologies and complementary services to enable the development and manufacture of biopharmaceutical products. Abzena's services and technologies are used by a range of companies and academic organisations across the pharmaceutical industry, including small biotech to large pharmaceutical companies. The company's proprietary technologies include composite human antibodies and site-specific conjugation technologies, which enable the development of antibody drug conjugates (ADCs) and other biotherapeutics. Abzena's services include antibody discovery and engineering, immunology services, bioassays, cell line development, and biomanufacturing. The company has a range of partnerships and collaborations with pharmaceutical companies and academic institutions, and has a number of products in clinical development.
