Analytical Development Scientist
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 lead analytical efforts on designated projects in alignment with other functions Product Development, Toxicology, Regulatory and Quality. The role will include management of a small group, in addition to providing independent contributions as dictated by project needs. The ability to develop novel and creative solutions to overcome project obstacles and make significant conceptual contributions to project teams are criteria for success.
- Provide technical support in developing and optimization of analytical methods to support process development, product pre – formulation studies, material release and in-process monitoring.
- Serve as the direct contact with clients and effectively communicate critical analytical issues and solutions.
- Set and justify drug substance and drug product specifications with the understanding of clinical study design and GMP processes.
- Understand process and formulation development to identify and document critical factors that impact method performance and/or analytical development activities.
- Develop, qualify and transfer (as applicable) analytical methods, suitable for progressive stages of product and process development. Generate assay qualification protocols and reports.
- Design assay qualification studies that are in compliance with ICH and FDA guidelines, and identify critical factors that may not be mandated by the guidelines but are essential for qualifying the methods for their intended use.
- Design stability studies for drug substance and drug product.
- Develop, review, and approve source documents for client’s regulatory submissions.
- Perform assay troubleshooting and improve analytical methods as needed. Data interpretation and analysis.
- Author and review Standard Test Methods and client’s product specific Analytical Test Methods.
- Support continuous improvement of lab processes for increased efficiency.
- Interact closely with Quality Control and PD Departments.
- Maintain Analytical lab equipment, follow the schedules for the appropriate calibration and maintenance activities. Provide assistance as needed during IQ/OQ of lab equipment.
- 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.
- MS degree in a relevant discipline, PhD is preferable (e.g., chemistry, biochemistry, biological sciences, bioengineering, etc.).
- Minimum seven (7) years of experience in analytical assay development/optimization.
- Required experience in optimization, development and qualification of analytical methods.
- Experience with the analytical methods such as HPLC , CE, DLS, DSC, HIAC and molecular biology techniques (PCR, immunoassays, SDS-PAGE, ELISA and functional assays) is required.
- Practical understanding of phase-appropriate analytical assay development and qualification
- 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.
- Ability to participate effectively as a team player in all aspects of Abzena business.
- Demonstrate sense of urgency; ability to recognize time sensitivity.
- Flexible and adaptable style with an eagerness to take on challenges.
- Problem solver who not only identifies issues but leads efforts to resolve them.
- Experience in working in GMP environments performing QC release tests.
- Leadership and motivational capabilities.
- Ability to supervise and manage employees as needed.