Sr Associate, Process Development - Downstream

Abzena Inc.•San Diego, CA

About The Position

The Senior Associate guides and oversees the work of Process Development Associates and junior personnel while supporting Scientists in developing scalable, robust processes on accelerated timelines. The role designs and performs downstream process development experiments, analyzes results, identifies process improvements, and leads project activities and technical transfers. It also supports scale-up, buffer preparation, documentation, data review, laboratory operations, and, as needed, protein purification and production under cGMP standards for clinical trial materials. The Senior Associate collaborates with clients and internal departments, represents Process Development in project meetings and training, and helps ensure laboratory requirements, quality standards, and production objectives are met. The role requires maintaining up-to-date knowledge of analytical methods, effective communication and teamwork, and travel between sites or to conferences and training as needed.

Requirements

BS or MS degree in biological sciences, chemistry, chemical engineering, biotechnology, biochemistry, or a related field.
At least 6 years of pharmaceutical or biotechnology experience with a BS, or at least 4 years with an MS.
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 analytical data interpretation.
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, depth filtration, and TFF, including the principles of 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 personal workload, oversee the workload of associates and laboratory technicians, and manage relevant resource requirements.
Ability to work effectively in a team and handle multiple tasks.
Comfort working in a fast-paced environment with minimal direction and adjusting workload as priorities change.
Experience applying creative, out-of-the-box thinking to solve day-to-day experimental challenges.
Leadership skills, including time management and planning.
Data management skills.
Microsoft Office suite skills.
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.
Frequently lift or move objects weighing up to 30 pounds.
Stand or walk for the entire length of the shift.
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 in regulatory regulations is desired.

Responsibilities

Design and execute process development experiments to understand operating and performance parameters, identify process improvements, analyze results, and plan follow-up experiments.
Train new personnel in specific technical processes.
Lead process development activities for projects and products in collaboration with colleagues and other departments.
Lead technical transfer of downstream purification processes from clients and between Process Development and internal groups such as Cell Line Development and MSAT/MFG.
Perform scale-up calculations across process scales, including cGMP scale.
Develop buffer formulations and prepare buffers according to protocols.
Document observations and collect data for analysis; participate in data management, trend identification, and notification of scientists about possible process or product impacts.
Conduct activities supporting production schedules and objectives as directed by senior staff.
Independently write study protocols, experimental designs, technical transfer reports, and development reports.
Interface with clients as needed throughout the development of their programs.
Oversee junior personnel and coordinate across departments to ensure Process Development laboratory requirements are met.
Maintain laboratory organization and cleanliness, stock supplies, perform scheduled cleanings, and manage supply inventory.
Assemble and autoclave tubing assemblies.
Maintain 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 and its activities in project team meetings, training, and evaluation of new technologies as needed.
Assist with protein purification under cGMP standards for clinical trial material as needed.
Assist with protein production under cGMP standards for clinical trial materials as needed.
Operate to high ethical and moral standards and comply with company policies, procedures, quality standards, regulations, and mission.
Communicate effectively with supervisors, colleagues, and staff, and participate as a team player across the business.
Travel between sites and attend professional conferences or training on new technologies as needed.
Perform other duties as assigned.