Senior Associate, Downstream
Location: San Diego, CA
Area: Process Development
- Designs and executes process development experiments to develop a thorough understanding of operating and performance parameters and identifies promising areas for process improvements. Effectively analyses experimental results and designs and executes follow-up experiments that build upon previous results.
- Guides and oversees the work of the Process Development (PD) Associates and junior personnel to support Scientists in the development of scalable and robust processes on accelerated timelines.
- Provides training to new personnel in specific technical processes.
- Leads process development activities for projects and products in collaboration with other individuals and departments.
- Leads the technical transfer of downstream purification processes from clients and between Process Development and other internal groups like Cell Line Development and MSAT/MFG.
- Leads performing scale-up calculations across varying scales of the process — up to cGMP scale.
- Develops buffer formulations and makes buffers accurately according to protocols.
- Documents observations and collects data for analysis. Participates in data management and the identification of trends in data and the notification of scientists of possible impacts to processes and products.
- Conducts activities in support of production schedules and objectives as directed by senior staff.
- Independently writes study protocols, experimental designs, technical transfer reports and development reports.
- Interfaces with clients, as needed, to follow the development of their program from start to finish.
- Oversees junior personnel and works interdepartmentally to ensure PD lab requirements are met. Maintains lab organization and cleanliness by regularly stocking supplies and managing supply inventory.
- Assembles and autoclaves tubing assemblies.
- Maintains cleanliness of specific equipment such as AKTA systems and biosafety cabinets.
- Assists scientists in data review and interpretation. Maintains up-to-date knowledge of quantitative and qualitative analytical methods.
- Represents Process Development and its activities as needed during project team meetings, training, and evaluation of new technologies.
- As needed, assists with protein purification under cGMP standards for clinical trial material.
- Performs other related duties as assigned.
- 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 staff.
- Participates effectively as a team player in all aspects of Abzena’s business.
- Travels as needed between sites, and to attend professional conferences and train on new technologies.
- BS or MS degree in biological sciences, chemistry, chemical engineering, biotechnology, biochemistry or related fields with 6+ or 4+ years’ experience, respectively, in the pharmaceutical or biotechnology fields.
- Advanced knowledge of recombinant protein expression and protein purification strategies using a variety of chromatographic techniques.
- Advanced knowledge in protein chemistry, quantitative and qualitative analytical methods and interpretation of analytical data.
- Strong understanding and extensive hands-on experience with AKTA systems and Unicorn software: GE- Pure, Avant, Pilot, and Ready.
- Strong understanding and extensive hands-on experience with centrifugation, depth filtration, TFF and principles of these operations.
- Knowledge of buffer formulation and preparation.
- Ability to follow instructions with minimal to no supervision and to maintain accurate records and notes to assist in writing detailed development reports.
- Practical experience with cGMP manufacturing operations and fluency of regulatory regulations is desired.
- Ability to organize workload, oversee workload of associates and lab technicians, and manage relevant resource requirements.
- Ability to work effectively in a team environment and motivated to work on multiple and various tasks, when required.
- Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.
- Skill in leadership duties including time management and planning.
- Skill in data management.
- Skill with Microsoft Office suite.
- Skills in problem solving and troubleshooting.
- Ability to safely operate production equipment in accordance with established practices.