Analytical Development Analyst
Location: San Diego, CA
Abzena San Diego is seeking a talented individual to join our Analytical Development group in San Diego, CA. As a member of the Analytical Development team, this role will support product development programs at Abzena. Specifically, the individual will provide a technical support in developing and optimization of analytical methods to support process development, product pre – formulation studies, material release and in-process monitoring; draft analytical test methods, product specifications, method qualification/validation protocols and reports.
- Provide technical support in developing and optimization of analytical methods to support process development, product pre – formulation studies, material release and in-process monitoring.
- Experienced/proficient at least three of the following methods: HPLC, CE, PCR, SDS-PAGE, ELISA, DLS, DSC, HIAC and functional assays.
- Support assays qualification and transfer to Quality Control lab, generate assay qualification and validation protocols and reports.
- Perform assay troubleshooting and improve analytical methods as needed. Data interpretation and analysis.
- Author and review Quality Control Standard Operating Procedures (SOPs), Assay Qualification and Stability Protocols.
- Author and review documents such as Standard Test Methods, Technical Reports.
- Support continuous improvement of lab processes for increased efficiency.
- Interact closely with Quality Control and R&D Departments.
- Maintain Analytical lab equipment, follow the schedules for the appropriate calibration and maintenance activities. Provide assistance as needed during IQ/OQ.
- Provide assistance as needed to maintain functioning Analytical Laboratory, including material ordering, inventory control and other duties.
- Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results with a customer driven focus.
- Safely operate laboratory equipment in accordance with established practices.
- Operates to the highest ethical and moral standards.
- Complies with Abzena’s policies and procedures.
- Adheres to quality standards set by regulations and Abzena’s policies, procedures and mission.
- Communicates effectively with supervisors, colleagues and subordinates.
- Ability to participate effectively as a team player in all aspects of Abzena business.
- Demonstrated administrative leadership with knowledge-based expertise in related areas that can be applied to meeting Abzena’s strategic goals.
- BS degree in a relevant discipline, (e.g., chemistry, biochemistry, biological sciences, bioengineering, etc.).
- Minimum three (3) years’ experience.
- Required experience in optimization, development and qualification of analytical methods.
- Experience with three or more of the analytical methods such as HPLC, CE, DLS, DSC, HIAC and molecular biology techniques (PCR, immunoassays, SDS-PAGE, ELISA and functional assays) is required.
- Experience with understanding basic principles of HPLC and plate based assays such as ELISAs.
- Knowledge of and experience in GMP, following STM’s, or willingness to become GMP proficient.
- Skill to accurately and precisely document and record laboratory activities, results, and conclusions.
- Ability to use routine laboratory equipment including, but not limited to, HPLCs, plate readers and electrophoresis equipment.
- Ability to work well under pressure, multi-task, be organized and have good communication skills.