We are seeking a highly motivated Sr. Process Engineer, Cell and Gene Therapy to support the Manufacturing Sciences and Technology team in leading and supporting internal/ external technology transfers and process support activities. We are looking for a candidate with high-level technical expertise from development into GMP manufacturing. This role will be responsible for overseeing and facilitating the transfer of new processes and technologies from developmental stages to manufacturing scale, ensuring seamless integration and optimal performance. The ideal candidate should be experienced in cell and gene therapy (autologous and allogeneic) processes and cGMP operations, and comfortable working in a fast-paced, entrepreneurial environment with broad responsibilities and opportunities. The candidate must collaborate effectively with cross-functional teams including Manufacturing Sciences and Technology, Supply Chain, QC, PD, AD, and Quality Assurance, as well as the Client to accomplish deliverables for GMP readiness.
This is a full-time, hybrid role for a biotech company in Alameda, CA, requiring onsite presence three times a week.
Key Responsibilities:
Technology Transfer Management:
Lead technology transfer projects, coordinating with cross-functional teams including Process Development and external partners.
Develop and implement technology transfer plans, ensuring adherence to timelines and quality standards.
Conduct risk assessments and development mitigations strategies for technology transfer activities.
Lead technology transfer discussions between sending units (Process Development and external partners) and receiving units (Manufacturing, QA, QC, SC, AD).
Responsible for authoring Manufacturing process descriptions, engineering protocols, technical reports, and material specifications. Reviewing and approving manufacturing batch records and any other relevant document to support successful transfer.
Create feasibility/gap assessments and facility fit analysis for new products and processes.
Process Optimization & Continuous Improvement:
Evaluate manufacturing processes and identify areas for improvement. Propose and implement innovative solutions to enhance process robustness and scalability.
Implement process enhancements to increase efficiency, reduce costs, and improve product quality.
Participate in continuous improvement initiatives within MSAT and Manufacturing departments.
Supervise/conduct lab work to resolve investigations and/or to demonstrate proof-of-concept for proposed changes.
Manufacturing Process Support:
Support process deviation investigations, root cause analyses, and CAPAs.
Train manufacturing staff on new processes and technologies.
Qualifications:
Bachelor's or Masters in a relevant field (e.g., Engineering, Biotechnology, Molecular Biology).
A minimum of 5-7 years of relevant experience in biopharmaceutical process engineering, with a focus on cell and gene therapy.
Proven experience in technology transfer, process development, and GMP manufacturing.
Experience with viral vector manufacturing, cell therapy, and mRNA is a plus.
Strong communication and project management skills, with a commitment to cross functional collaboration.
Knowledge of cGMP and regulatory guidelines (e.g., FDA, EMA) and a track record of ensuring compliance.
Basic understanding of lifecycle management of clinical and commercial manufacturing processes.
Ability to analyze and interpret data and contextualize with the program goals and requirements in a phase-appropriate manner.