Downstream Process Development Lead – Biologics

Abzena; San Diego (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Abzena is seeking a Senior Associate to guide Process Development (PD) work, supervising PD Associates and junior staff to support scientists in developing scalable processes on accelerated timelines.

You will lead process development activities, drive tech transfers with Cell Line Development and MSAT/MFG, and contribute to cGMP-scale scale-up while ensuring data quality and client satisfaction.

Qualifications

• BS or MS in biological sciences or related field with 6+ (BS) or 4+ (MS) years in pharma/biotech.
• Advanced knowledge of recombinant protein expression and purification via chromatography.
• Strong knowledge of protein chemistry and analytical methods.
• Hands-on experience with AKTA systems and Unicorn software (GE-Pure, Avant, Pilot, Ready).
• Experience with centrifugation, depth filtration, and tangential flow filtration (TFF).
• Knowledge of buffer formulation.
• Ability to follow instructions with minimal supervision and maintain records.
• Practical experience with cGMP manufacturing operations; regulatory familiarity is valued.
• Leadership, time management, and planning skills.
• Proficiency with MS Office; problem solving and troubleshooting.
• Safe operation of production equipment.

Responsibilities

• Designs and executes process development experiments; analyzes results and plans follow-up tests.
• Provides training to new personnel in technical processes.
• Leads process development activities and collaborates with other departments.
• Leads technical transfer of downstream processes between PD and other groups.
• Performs scale-up calculations up to cGMP scale.
• Develops buffer formulations and prepares buffers per protocols.
• Documents observations and collects data for analysis; writes reports.
• Interfaces with clients to oversee development from start to finish.
• Oversees junior personnel and ensures PD lab requirements are met.
• Travels between sites and to conferences to train on new technologies.
• Assists with protein production under cGMP standards for clinical materials.

Skills

AKTA systems

Unicorn software

Leadership

Data management

Time management

Education

BS or MS in biological sciences/related field

Tools

AKTA systems

Unicorn software (GE-Pure/Avant/Pilot/Ready)

Job description

Abzena is seeking a Senior Associate to guide Process Development (PD) work, supervising PD Associates and junior staff to support scientists in developing scalable processes on accelerated timelines.

You will lead process development activities, drive tech transfers with Cell Line Development and MSAT/MFG, and contribute to cGMP-scale scale-up while ensuring data quality and client satisfaction.