Senior MSAT/Process Development/Tech Transfer Engineer (cGMP – Biologics Manufacturing)

Summary:

We are looking for a proven Process Development/Manufacturing resource to join our Life Sciences team in support of a client company supporting tech transfer and scale up activities of biologic molecules for GMP clinical or commercial production. Specific experience with advanced therapies manufacturing i.e. viral vector, RNA, and/or cell processing is preferred.

Roles and Responsibilities:

• Provide leadership within cross-functional teams to achieve facility start-up and technology transfers. This is expected to involve ensuring the facility fit and technical transfer is successful, compliant, and efficient, while maintaining a strong focus on collaboration, communication, and quality.
• Interact with process development teams on process design finalization (and control strategy as applicable) in terms of facility/equipment specifics, manufacturability, capacity and cost analysis, process controllability and robustness.
• Ensure accurate and comprehensive documentation of all steps in the transfer process. This documentation is crucial for regulatory submissions, troubleshooting, and future improvements.
• Execute technical assessments of new equipment, instruments, and single-use technology to identify optimal solutions in a fast-paced environment.
• Owner and author of relevant documents which represent the process for GMP manufacturing including, but not limited to SOPs, process descriptions, master batch records, compounding records, critical raw material lists, bill of materials, part number generation, and sample map.
• Owner and author of process related change controls, deviations and CAPA to ensure events have no impact to process performance and product quality, and recurrence is eliminated.

Position Requirements and Qualifications:

• Minimum of 7 years’ experience with biotech process development, process scale up, tech transfer or manufacturing in the biopharma/biotech industry.
• Prior direct experience in either design, qualification, start-up, or initial licensure of biologics manufacturing facilities preferred.
• Demonstrated evidence of detailed direct experience with process, equipment, single-use technology, automation, validation, and facility fit knowledge.
• Thorough understanding and demonstrated experience with FMEA, risk analysis, process characterization or process validation.
• Knowledge of quality systems, cGMP, regulatory and industry standards at all phases of drug development.
• Experience with statistics in the areas of statistical process control, modeling, and data management.
• Ability to solve complex problems, and a proactive preventative mindset to enable flawless manufacturing.
• Strong interpersonal and communication skills – able to clearly express ideas and point of view both verbally and in writing.

Education:

Bachelors Degree in relevant biotechnology, biological sciences, or chemical engineering fields required.