Job Title: Director of Process Development
Location: Bay Area, CA
Reports to: Vice President of R&D
About our Client:
Our client is an innovative, mid-sized cell therapy company dedicated to developing cutting-edge therapies that address unmet medical needs.
Position Overview:
We are seeking a dynamic and results-driven Director of Process Development to lead and oversee the development and optimization of manufacturing processes for our biopharmaceutical products. This role will be critical in ensuring the scalability, reproducibility, and regulatory compliance of our processes as we advance our pipeline into clinical trials and commercial production. The ideal candidate will have deep expertise in process development, strong leadership skills, and a passion for driving innovation within a fast-paced and growing biotech environment.
Key Responsibilities:
- Oversee and manage the design, optimization, and scale-up of processes for the production of biologic drugs, including cell culture, purification, and formulation development. Ensure processes are robust, reproducible, and meet the regulatory standards for clinical and commercial manufacturing.
- Manage and mentor a cross-functional team of scientists, engineers, and technicians focused on process development activities. Foster a culture of collaboration, continuous learning, and excellence within the team.
- Work closely with R&D, analytical development, quality control, and manufacturing teams to ensure seamless transition from development to clinical manufacturing. Provide process insights and troubleshooting support to manufacturing operations.
- Lead the development of process characterization and validation strategies to ensure processes are scalable and meet GMP requirements. Manage the design and execution of process qualification, stability studies, and process performance qualification.
- Ensure that all process development activities comply with regulatory requirements (e.g., FDA, EMA, ICH guidelines) and internal quality standards. Prepare regulatory filings and documentation related to process development activities.
- Drive continuous process improvement initiatives through the implementation of new technologies, data analytics, and lean methodologies to reduce cost, improve efficiency, and enhance product quality.
- Oversee the process development budget, manage resource allocation, and ensure timely execution of process development milestones.
- Regularly update executive leadership and stakeholders on progress, milestones, risks, and opportunities related to process development.
Qualifications:
- Ph.D. in Biochemistry, Chemical Engineering, Molecular Biology, or a related field.
- Alternatively, M.S. with significant experience (10+ years) in process development for biologics.
- Minimum of 8-10 years of experience in process development within the biotech or biopharmaceutical industry, with at least 3 years in a leadership role.
- Strong hands-on experience with upstream and downstream bioprocessing (e.g., cell culture, protein purification, chromatography).
- In-depth knowledge of GMP manufacturing, process validation, and regulatory requirements.
- Experience with biologic modalities (e.g., monoclonal antibodies, gene therapies, recombinant proteins).
- Proven ability to lead, mentor, and build high-performing teams in a fast-paced environment.
- Strong communication, interpersonal, and project management skills.
- Strong understanding of process scale-up and technology transfer.
- Expertise in the design and implementation of process characterization and process development strategies.
- Familiarity with data-driven approaches, process analytics, and continuous process improvement methodologies (e.g., DoE, Lean, Six Sigma).
- Ability to tackle complex technical challenges and provide creative solutions in a resource-constrained environment.
Compensation
- $220,000-$255,000 base salary dependent on experience. Discretionary bonus and LTIs.
