Senior Director, Downstream Process Development

Avid Bioservices; 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 Tustin, CA, is seeking a Director, Process Development Downstream to lead a team of scientists and engineers in developing and scaling downstream purification processes for biologics. The role partners with Manufacturing, MSAT, Analytical Development, Quality, and Project Management to deliver robust, scalable solutions and to transfer technologies to GMP manufacturing.

You will shape technical strategy, drive continuous improvement, manage risks, and ensure quality and

Qualifications

• Master's degree in chemical engineering, biochemical engineering, biochemistry, biotechnology, pharmaceutical sciences, or related field (or equivalent).
• At least 10 years in biopharmaceutical process development, with significant downstream purification experience.
• At least 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 technology transfer into GMP manufacturing.
• Knowledge of phase-appropriate process development, data integrity, GMP expectations, and regulatory principles.
• Experience reviewing and authoring technical protocols, reports, development plans, transfer documents, and client-facing materials.
• Ability to communicate complex technical information to clients, technical teams, cross-functional stakeholders, and senior leaders.

Responsibilities

• Lead, coach, and develop approximately five scientists and engineers for downstream process development and client program delivery.
• Direct development and optimization of purification processes for biologics and recombinant proteins, focusing on robustness and scalability.
• Provide technical oversight for chromatography, depth filtration, tangential flow filtration, viral inactivation, virus filtration, scale-up, and technology transfer.
• Lead the transfer of knowledge from clients and internal teams to Manufacturing and supporting functions.
• Ensure successful scale-up and provide technical support for engineering, clinical, validation, and commercial manufacturing activities where applicable.
• Serve as a senior technical representative in client meetings, reviews, presentations, proposals, scoping, and due diligence.
• Identify gaps and risks, then implement mitigation strategies.
• Review and approve protocols, reports, development plans, and transfer packages within authority.
• Partner with Manufacturing, MSAT, Analytical Development, QA/QC, Supply Chain, Business Development, and Project Management to coordinate execution and resolve issues.
• Set team priorities, resource plans, objectives, and operating practices aligned with commitments, safety, and business needs.
• Lead continuous improvement initiatives to enhance process quality, delivery, cost, productivity, and technical consistency.
• Evaluate new downstream technologies and recommend capabilities aligned with strategy.
• Support budget planning, equipment investments, workforce planning, recruiting, and performance management.
• Provide timely updates to senior leadership on program status, risks, and actions.

Skills

People leadership

Technical communication

Cross-functional collaboration

Project management

Attention to detail

Education

Master's degree in chemical/biochemical engineering or related

Ph.D. in chemical/biochemical engineering or related

Job description

Avid Bioservices in Tustin, CA, is seeking a Director, Process Development Downstream to lead a team of scientists and engineers in developing and scaling downstream purification processes for biologics. The role partners with Manufacturing, MSAT, Analytical Development, Quality, and Project Management to deliver robust, scalable solutions and to transfer technologies to GMP manufacturing.

You will shape technical strategy, drive continuous improvement, manage risks, and ensure quality and