Director, Process Development Downstream

Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes.
Your Role:
The Director, Process Development Downstream provides technical and people leadership for downstream process development, biologics formulation development, and process analytics support activities. The Director will lead a function that enables the tech transfer of our clients’ projects, from initial development runs through scale-up and transfer to manufacturing scale. Reporting to the Chief Technology & Transformation Officer, this role leads a downstream process development organization of approximately 19 scientists, engineers, and research associates, with approximately six direct reports, and is responsible for building a new Formulation Development function. The combined organization is planned to grow to more than 40 employees over the next several years. Together, these teams develop robust, scalable purification processes and stable drug product formulations for biologic and recombinant protein products expressed in mammalian cell systems, supported by in-process analytical testing. The Director establishes an integrated technical strategy across these functions, ensures the quality and timely execution of development programs, and proactively addresses risks that may affect process performance, product stability, manufacturability, or project delivery. Working closely with clients and cross-functional partners, the role translates process and formulation knowledge into successful manufacturing outcomes and scales the downstream and formulation organization in line with the business plan.
Key Responsibilities:
Lead, coach, and develop a downstream process development organization of approximately 19 scientists, engineers, and research associates, including approximately six direct reports who lead the downstream and formulation development teams.
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.
Establish and direct the biologics formulation development, including preformulation and formulation screening, excipient selection, buffer and formulation optimization, and stability study design, to deliver stable and manufacturable drug substance and drug product formulations.
Oversee process analytics supporting downstream and formulation development, including in-process to generate reliable data with quick turnaround times that informs process and formulation decisions.
Integrate downstream purification, formulation, and analytical activities into cohesive development plans and technology transfer packages.
Lead the transfer of downstream process and formulation 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