Description

Your Role:
The Director, Process Development Downstream provides technical and people leadership for downstream process development activities supporting biologic products from early development through scale-up, technology transfer, and manufacturing implementation. This role leads approximately five scientists and engineers who develop robust, scalable purification processes for biologic and recombinant protein products expressed in mammalian cell systems. The Director establishes technical strategy, ensures the quality and timely execution of development programs, and proactively addresses risks that may affect process performance, manufacturability, or project delivery. Working closely with clients and cross-functional partners, the role translates process knowledge into successful manufacturing outcomes and advances continuous improvement and emerging downstream capabilities.

Key Responsibilities:

• Lead, coach, and develop approximately five scientists and engineers responsible for downstream process development and client program delivery.
• Direct the development and optimization of purification processes for biologics and recombinant proteins, emphasizing robustness, scalability, product quality, and manufacturability.
• Provide technical oversight for chromatography, depth filtration, tangential flow filtration, viral inactivation, virus filtration, process characterization, scale-up, and technology transfer activities.
• Lead the transfer of downstream process knowledge from clients and internal development teams to Manufacturing and supporting functions.
• Ensure successful scale-up and provide technical support for engineering, clinical, validation, and commercial manufacturing activities, as applicable.
• Serve as a senior technical representative in client meetings, project reviews, technical presentations, proposal development, project scoping, and technical due diligence.
• Identify technical gaps and development risks, then establish and execute scientifically sound mitigation strategies.
• Review and approve technical protocols, reports, development plans, and transfer packages within delegated authority.
• Partner with Manufacturing, MSAT, Analytical Development, Quality Assurance, Quality Control, Supply Chain, Business Development, and Project Management to coordinate execution and resolve technical or operational issues.
• Establish team priorities, resource plans, objectives, and operating practices that support program commitments, quality expectations, safety requirements, and business needs.
• Lead continuous improvement initiatives that enhance process quality, delivery, cost, productivity, and technical consistency.
• Evaluate new and emerging downstream technologies and recommend capabilities that support the organization's technical strategy.
• Support budget planning, equipment and technology investments, workforce planning, recruiting, and performance management.
• Provide clear and timely technical and operational updates to senior leadership, including program status, emerging risks, and recommended actions.

Minimum Qualifications:

• Master's degree in chemical engineering, biochemical engineering, biochemistry, biotechnology, pharmaceutical sciences, or a related discipline, or an equivalent combination of relevant education and experience.
• At least 10 years of relevant experience in biopharmaceutical process development, including significant experience developing downstream purification processes for biologic products.
• At least 5 years of experience leading technical teams, people, or complex downstream process development programs.
• Demonstrated experience with downstream unit operations such as chromatography, depth filtration, tangential flow filtration, viral inactivation, and virus filtration.
• Demonstrated experience with process scale-up and technology transfer into a GMP manufacturing environment.
• Working knowledge of phase-appropriate process development, process characterization, data integrity, GMP expectations, and applicable regulatory principles.
• Experience reviewing and authoring technical protocols, reports, development plans, transfer documents, and client-facing technical materials.
• Ability to communicate complex technical information effectively to clients, technical teams, cross-functional stakeholders, and senior leaders.

Preferred Qualifications:

• Ph.D. in chemical engineering, biochemical engineering, biochemistry, biotechnology, pharmaceutical sciences, or a related discipline.
• Experience in a biologics contract development and manufacturing organization (CDMO).
• Experience supporting monoclonal antibodies, recombinant proteins, or other mammalian-cell-derived biologics through clinical or commercial development.
• Experience with process characterization, validation readiness, viral clearance strategy, and regulatory filing support.
• Experience evaluating or implementing new downstream processing technologies, automation, or platform approaches.

Position Type/Expected Hours of Work:

This role is a full-time onsite position in Tustin, CA. Days and hours of work are Monday through Friday 8:00 a.m. to 5:00 p.m. unless otherwise stated by Supervisor. The employee must also have the ability to work overtime and/or weekends when necessary.

Compensation:

We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.

The compensation range for this role is $177,600 to $222,000 annually depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.

Who you are:

• You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
• Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
• You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
• You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.

Physical Demands & Work Environment:

In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 25 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.