Sr. Scientist Analytical Method Development
Location: San Diego, CA
The Sr. Scientist Analytical Method Development will develop direct execute and document Scientific development projects in support or product development programs at Abzena San Diego. Specifically, the individual will develop and optimize analytical methods to support process development, in-process monitoring, drug substance and drug product testing, specifications, method qualification/validation protocols and reports.
Typical Duties Include
- Develops and conducts independently and/or collaboratively all aspects of analytical methods to support process development, product pre – formulation studies, in in-process monitoring, drug substance and drug product testing.
- Expertise in the following methods HPLC separations, HPLC-MS, Capillary Electrophoresis, ELISA Immunoassays, Western blots, Protein Titer (HPLC, ELISA and SPR) and other analytical protein characterization methods.
- Performs method pre-qualification, author analytical test methods, qualification protocols/reports, reviews stability protocol/reports, leads method transfer to Quality Control laboratory.
- Acts as an intellectual resource for his/her area of expertise by supporting assay troubleshooting and improve analytical methods as needed. Data interpretation and statistical analysis.
- Acts as an effective team player achieving corporate objectives through active participation in project teams and initiation and maintenance of effective interactions with clients and Abzena sites.
- Participates in strategic thinking, planning and communicates scientific data and concepts effectively
- Maintains and demonstrates knowledge of the drug development process from development through commercial manufacturing including regulatory requirements and guidance.
- 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.
- Serves as mentor and trains junior personnel.
- BS degree ≥10 year, MS with ≥5 years or PhD with experience post degree ≥3 years in a relevant discipline, (e.g., chemistry, biochemistry, biological sciences, bioengineering, etc.).
- Required experience in method development/optimization, qualification and validation of analytical methods.
- Required knowledge and application of analytical technologies involving primarily HPLC separations, HPLC-MS, Capillary Electrophoresis, Western blots, Immunoassays (ELISA, bioassay) other analytical protein characterization methods.
- Knowledge and experience in cGMP, ICH guidelines, USP, EP following STM’s.
- Ability to work well under pressure, multi-task, be organized and have good communication skills.
- Good oral and written communication skills.
- Ability to work both independently and collaboratively.