Sr Associate, Process Development - Downstream

Abzena•San Diego, CA

About The Position

The Senior Associate, Process Development - Downstream guides and oversees Process Development Associates and junior personnel while supporting Scientists in developing scalable, robust processes on accelerated timelines. The role leads downstream process development and technical transfers, performs scale-up calculations through cGMP scale, and contributes to process understanding, improvement, and data interpretation. It also supports production schedules, client programs, laboratory operations, and, as needed, protein purification and production for clinical trial materials under cGMP standards. The position requires advanced knowledge and hands-on experience in recombinant protein expression and purification, chromatographic techniques, AKTA systems and Unicorn software, centrifugation, depth filtration, and tangential flow filtration (TFF). The Senior Associate prepares buffers, maintains equipment and laboratory organization, documents and reports experimental work, trains personnel, and collaborates with clients and internal teams. The role involves travel between sites and to professional conferences or training as needed.

Requirements

BS degree in biological sciences, chemistry, chemical engineering, biotechnology, biochemistry, or a related field with 6 or more years of experience in the pharmaceutical or biotechnology fields; or an MS degree in one of these fields with 4 or more years of experience.
Advanced knowledge of recombinant protein expression and protein purification strategies using a variety of chromatographic techniques.
Advanced knowledge of 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, including GE Pure, Avant, Pilot, and Ready.
Strong understanding and extensive hands-on experience with centrifugation and depth filtration, TFF, and the principles behind these operations.
Knowledge of buffer formulation and preparation.
Ability to follow instructions with minimal to no supervision and maintain accurate records and notes to support detailed development reports.
Ability to organize workload, oversee associates' and laboratory technicians' workloads, and manage relevant resource requirements.
Ability to work effectively in a team and handle multiple and varied tasks as needed.
Comfort working in a fast-paced environment with minimal direction and adjusting workload as priorities change.
Ability to apply creative, out-of-the-box thinking to day-to-day experimental challenges.
Leadership skills, including time management and planning.
Data management skills.
Proficiency with the Microsoft Office suite.
Problem-solving and troubleshooting skills.
Ability to safely operate production equipment according to established practices.
Ability to stand for 1–2 hours at a time and sit for 2–3 hours at a time.
Ability to frequently lift or move objects weighing up to 30 pounds.
Ability to stand and walk throughout the entire shift.
Ability to use arms, hands, and fingers to handle, feel, or reach.
Ability to climb, balance, stoop, kneel, crouch, or crawl.
Visual abilities including near and far sight, color vision, peripheral vision, depth perception, and ability to focus.

Nice To Haves

Practical experience with cGMP manufacturing operations and fluency with regulatory regulations.

Responsibilities

Design and execute process development experiments to understand operating and performance parameters and identify process improvements.
Analyze experimental results and design and execute follow-up experiments.
Train new personnel in specific technical processes.
Lead process development activities for projects and products in collaboration with individuals and departments.
Lead technical transfers of downstream purification processes from clients and between Process Development and internal groups, including Cell Line Development and MSAT/MFG.
Perform scale-up calculations across process scales, up to cGMP scale.
Develop buffer formulations and prepare buffers according to protocols.
Document observations, collect data, and participate in data management and trend identification; notify scientists of possible impacts to processes and products.
Conduct activities supporting production schedules and objectives as directed by senior staff.
Write study protocols, experimental designs, technical transfer reports, and development reports independently.
Interface with clients as needed throughout the development of their programs.
Oversee junior personnel and work across departments to ensure Process Development laboratory requirements are met.
Maintain laboratory organization and cleanliness, stock supplies, conduct scheduled cleanings, and manage supply inventory.
Assemble and autoclave tubing assemblies.
Maintain the cleanliness of equipment, including AKTA systems and biosafety cabinets.
Assist scientists with data review and interpretation.
Maintain up-to-date knowledge of quantitative and qualitative analytical methods.
Represent Process Development during project team meetings, training, and evaluation of new technologies as needed.
Assist with protein purification and protein production under cGMP standards for clinical trial materials as needed.
Follow ethical standards, company policies and procedures, and applicable quality standards and regulations.
Communicate effectively and participate as a team player across Abzena's business.
Travel between sites and attend professional conferences or training on new technologies as needed.
Perform other duties as assigned.