Director, Biologic Downstream Process Development

avidbio; Tustin (CA); On-site; USD 178,000 - 222,000; Full time

Benefits offered by this job

Health insurance

401(k) matching

Paid time off

Job summary

Avid Bioservices in California seeks a Director of Process Development Downstream to lead a team of scientists and engineers in developing robust downstream purification processes for biologics, from early development through scale-up and tech transfer. You will partner with cross-functional teams to ensure quality, manufacturability, and project delivery in a GMP environment.

The role requires a master’s (or PhD preferred) in a related field and 10+ years of biopharma downstream experience,

Qualifications

• Master's degree or equivalent in chemical/biochemical engineering, biochemistry, biotechnology, or pharmaceutical sciences.
• Minimum 10 years in biopharmaceutical process development with downstream purification experience.
• Minimum 5 years leading technical teams or complex downstream programs.
• Experience with downstream unit operations: chromatography, depth filtration, tangential flow filtration, viral inactivation, virus filtration.
• Experience with process scale-up and tech transfer into GMP manufacturing.
• Knowledge of process development, data integrity, GMP expectations, and regulatory principles.
• Ability to communicate complex technical information to clients and senior leadership.

Responsibilities

• Lead ~5 scientists and engineers for downstream process development and client programs.
• Develop and optimize purification processes for biologics and recombinant proteins.
• Provide oversight for chromatography, depth filtration, TFF, viral inactivation, and virus filtration.
• Lead technology transfer from development to Manufacturing and other functions.
• Support scale-up, engineering, validation, and commercial manufacturing activities.
• Represent technical aspects in client meetings, reviews, and proposals.
• Identify gaps and risks; implement mitigation strategies with data-driven plans.
• Review and approve protocols, reports, and transfer packages.

Skills

Process development leadership

Downstream purification

Biopharma GMP

Team leadership

Project management

Communication skills

Education

Master's degree in chemical/biochemical engineering

PhD in related field (preferred)

Tools

Chromatography

Depth filtration

Tangential flow filtration

Viral inactivation

Virus filtration

Job description

Avid Bioservices in California seeks a Director of Process Development Downstream to lead a team of scientists and engineers in developing robust downstream purification processes for biologics, from early development through scale-up and tech transfer. You will partner with cross-functional teams to ensure quality, manufacturability, and project delivery in a GMP environment.

The role requires a master’s (or PhD preferred) in a related field and 10+ years of biopharma downstream experience,