Downstream/Purification Associate Scientist
Location: San Diego, CA
Area: Manufacturing / Protein Purification
- Provides technical competency in support of daily operations through research in diverse biological processes.
- Uses current scientific literature with the technical capability to select methods and techniques for obtaining solutions within broadly defined practices and procedures.
- Produces purified proteins to support lead generation/optimization and preclinical studies.
- Produces purified proteins under cGMP standards and with cGMP standards and regulations in consideration for production of clinical trial materials.
- Participate in technical transfer of downstream manufacturing processes from clients and between Development and Manufacturing groups.
- May lead client projects including the planning, execution, and wrap up.
- Exercises technical discretion in design, execution and interpretation of manufacturing and production that contributes to project goals.
- Provides detailed observations, analyzes data, and interprets results.
- Act as a Subject Matter Expert (SME) to train others in areas of expertise. Assists and offers guidance to the Process Development group and Manufacturing group as necessary.
- Assists in monitoring production or purification schedules, materials, equipment and manpower requirements.
- Maintains records to comply with regulatory requirements and assists with in-process testing, as needed.
- Prepares or orders media and buffer components. Operates, and assists in maintaining production equipment as it relates to protein purification.
- Learns to initiate deviations, assess product quality impact, and propose Corrective and Preventative Actions (CAPA), as needed.
- Sets up and performs scale down models to assist with process validations, viral clearance studies, and manufacturing investigations, providing analysis as needed.
- Drafts technical reports, summaries, protocols, batch records and quantitative analyses.
- Uses professional concepts in accordance with company objectives to solve simple to moderately-complex problems in creative and effective ways.
- Organizes own daily workload schedule and relevant resource requirements.
- Operates with minimal supervision on complex systems and equipment.
- May lead and direct the work of junior personnel in the field.
- Supports project teams on multiple projects simultaneously.
- Represents departmental activities as needed, including project teams, task forces, audits and business or technical meetings with outside groups.
- Develops effective working relationships with both internal and external partners.
- Performs other related duties as required.
- Operates to the highest ethical and moral standards.
- Complies with Abzena’s policies and procedures.
- Adheres to quality standards set by regulations and Abzena policies, procedures and mission.
- Communicates effectively with supervisors, colleagues and subordinates.
- Ability to participate effectively as a team player in all aspects of Abzena’s business.
- Demonstrates administrative leadership with knowledge-based expertise in related areas that can be applied to meeting Abzena’s strategic goals.
- Travels as needed.
- Minimum BS degree in an applicable scientific field, plus a minimum of eight (8) years directly related experience; or, MS degree in an applicable scientific field with a minimum of three (3) years industrial experience in process development and cGMP manufacturing.
- Ability to apply principles, theories and concepts in specialized area of responsibility, together with working knowledge of related disciplines.
- Knowledge of purification process steps, including depth filtration, tangential flow filtration, chromatography, and viral filtration.
- Knowledge of products manufacturing following SOPs, batch records and working within a cGMP regulated environment.
- Ability to observe technical issues with troubleshooting knowledge of process and equipment problems.
- Ability to operate complex systems and equipment and optimize their use in manufacturing in accordance with defined goals.
- Knowledge of specific product-related operations in protein purification.
- Ability to mentor and train purification associates and leads in process transfer, scale-up, from scientific and engineering perspective.