MSAT Drug Product Lead

Job Description

Manufacturing Science & Technology (MSAT) is a department within the Manufacturing Operations Division. MSAT has responsibility for drug substance and drug product tech transfer and manufacturing readiness, technical oversight, and data analysis of various modalities of viral vector. Drug Product Manufacturing Science and Technology (DP MSAT) is a team within a broader MSAT team at the Center of Breakthrough Medicines. DP MSAT provides technical support for enabling readiness, robustness and GMP compliance of fill/finish manufacturing processes for gene therapy products. MSAT Drug Product Lead ensures that formulation, fill/finish and cryopreservation steps in drug product manufacturing processes are optimized, scalable and compliant through strong collaboration and guidance from Drug Product Process Development, Quality and Manufacturing Operations teams.

Primary Responsibilities:
• Management of a team of scientists and/or engineers
• Work closely with process development and/or client in leading process knowledge transfer to scale-up process for pilot and GMP operations
• Support Process Fit to Plant evaluation
• Author protocols to support GMP manufacturing campaign where applicable
• Provide hands-on technical support during GMP production, as necessary
• Author knowledge transfer documentation for GMP manufacture (e.g., bill of materials, process flow diagrams, and sample plans)
• Partner with manufacturing, engineering, and quality to establish process-specific batch records for GMP manufacture.
• Collaborate with process development scientists and manufacturing to establish technology transfer plan and perform technical risk assessment for the product/process introduction to the GMP facility.
• Provide technical support for process-related issues or investigations.
• Work with outside vendors to expand drug product clinical and commercial capabilities
• Support client regulatory filing as necessary
• Contribute to overarching MSAT goals by ensuring the effective integration of process knowledge into manufacturing operations.
• Responsible for change control impact assessments, investigations, and other quality system deliverables.
• Lead fill/finish manufacturing processes from a technical perspective for early clinical phase through and commercial manufacturing.
• Represent DP MSAT in process control strategy development, including execution of process risk assessment, justification of process parameters range, and criticality analysis.

Education & Experience
• BS (7+ years experience), MS (3+ years experience), or Ph.D. (0-2 years experience) in Chemical Engineering, Biomedical Engineering, Biology, or similar life sciences degree with experience in drug product formulation and filling technologies and demonstrated laboratory proficiency.

Key Competencies:
• Proven experience with equipment and manufacturing processes commonly used for fill/finish of viral vectors (i.e., automated and semi-automated filling equipment, sterile filtration, filter integrity testing, aseptic process simulation, single use systems, etc.) and ability to train junior staff)
• Robust experience in technology transfer from development into a cGMP Manufacturing.
• Direct experience designing and executing APS activities to support GMP manufacturing.
• Direct experience working in quality systems, authoring and review of GMP and technical documents.
• Previous experience in facility commissioning, equipment qualification and maintenance is highly preferred.
• Thorough understanding of GMP requirements and their relation to process operations.
• Demonstrated project management capabilities.
• Self-motivated with strong interpersonal and organizational skills.
• Emotional intelligence to communicate and interact internally and with clients to drive program deliverables.
• Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities
• Commercial drug product experience is preferred

Physical Requirements:
• Prolonged periods of sitting at a desk and working on a computer.
• Must be able to lift up to 15 pounds at times.
• Standing/working in a lab/ GMP setting for more than 4 hours when needed