Senior Downstream Process Development Lead (Biologics)

Abzena Inc.; San Diego (CA); Presencial; USD 90.000 - 130.000; Jornada completa

Descripción de la vacante

Abzena Inc. is seeking a Senior Associate in Process Development to guide PD Associates and oversee scalable protein purification and transfer activities. The role supports scientists, develops robust processes, and coordinates with multiple departments to meet accelerated timelines.

Responsibilities include experimental design, data analysis, protocol writing, and client communication. The candidate will help ensure cGMP compliance and maintain laboratory standards across sites.

Formación

• BS or MS in biological sciences, chemistry, chemical engineering, biotechnology, biochemistry or related field with 6+ (BS) or 4+ (MS) years in pharma/biotech.
• Advanced knowledge of recombinant protein expression and purification using chromatographic techniques.
• Strong background in protein chemistry and analytical methods.
• Hands-on experience with AKTA systems and Unicorn software.
• Experience with cGMP manufacturing operations and regulatory knowledge.
• Ability to lead, organize workload, and manage resources.

Responsabilidades

• Designs and executes process development experiments to understand operating parameters and identify improvements.
• Provides training to new personnel on technical processes.
• Leads process development activities across projects in collaboration with other teams.
• Leads technical transfer of downstream purification 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.
• Maintains lab organization and stock of supplies.
• Interacts with clients to follow development through to production.
• Assists with protein production under cGMP standards for clinical trial material.

Conocimientos

Protein expression

Protein purification

AKTA systems

Unicorn software

cGMP manufacturing

Data management

Team leadership

Regulatory knowledge

Problem solving

Educación

BS or MS in biological sciences/chemistry/engineering/biotech/biochemistry

Herramientas

AKTA systems

Unicorn software: GE-Pure/Avant/Pilot/Ready

Microsoft Office

Descripción del empleo

Abzena Inc. is seeking a Senior Associate in Process Development to guide PD Associates and oversee scalable protein purification and transfer activities. The role supports scientists, develops robust processes, and coordinates with multiple departments to meet accelerated timelines.

Responsibilities include experimental design, data analysis, protocol writing, and client communication. The candidate will help ensure cGMP compliance and maintain laboratory standards across sites.