Sr. Director - Manufacturing and MS&T

Roslin CT US Holdings,LLC • Hopkinton, MA

94d • $237,475 - $260,000

About The Position

Your day-to-day will include applying knowledge and background in manufacturing sciences and engineering of cell therapies to guide the Manufacturing and MS&T team for the tech transfer and production of clinical and commercial cell therapy products. You will interface directly with internal/external partners, develop and lead technology transfer plans, and evaluate and implement process improvement effects. You will coordinate and oversee the execution of production operations and support QC and QA testing and disposition to ensure timely production, testing and release of quality cell therapies, troubleshooting instruments and assays, investigating deviations, and supporting product disposition evaluations. You will lead the manufacturing of client cell therapy products for clinical and commercial supply, oversee the implementation of capable processes for manufacturing, and manage the cell therapy manufacturing facility. Additionally, you will provide leadership oversight and build strong technical Manufacturing and MSAT teams at the Hopkinton manufacturing site and any future manufacturing sites. You will also provide leadership to oversee the operation of all cGMP cell therapy manufacturing suites including process and equipment troubleshooting, forecasting, and capacity management. Support business development efforts through detailed technical assessment, equipment, and resource utilization analysis. Ensure required Manufacturing and MSAT support for maintaining and improving manufacturing success rates through establishment of effective deviation resolution, continuous improvement, and knowledge management systems. Deliver safe, effective, and cGMP-compliant cell product to clients for clinical studies and commercial use according to strict project timelines and budget. Establish phase-appropriate and seamless process and analytical knowledge transfer from partners to Manufacturing and QC, thereby achieving high manufacturing success rates and on-time IND approvals. Identify risks and propel continuous improvements (process, safety, quality, costs) in development and manufacturing process through technological innovation and alignment with regulatory requirements for clinical and commercial cell therapy manufacturing. Build a flexible Manufacturing and MSAT organization and equipment/instrument portfolio that optimally fulfills RoslinCT’s partnership commitments and goals. Identify and establish new capabilities as necessary in areas such as technology transfers, process validation, comparability, new materials, critical raw materials, and advanced analytics. Develop and maintain systems for effective knowledge sharing, internally and with external partners, as well as building process engineering knowledge for cell therapy constructs that are of strategic interest to RoslinCT and its partners. Ensure the requisite technical expertise to support regulatory filings and health authority questions as necessary at all stages of product development. Work collaboratively with and be a thought-partner to manufacturing, quality, operations, finance, and business development leadership to ensure all cross functional goals and responsibilities are effectively met on a regular basis. Exercise technical discretion in the design, execution, and interpretation of experiments that contribute to project strategies and goals. You will supervise 24 subordinates – Managers and Sr. Managers of MSAT and Manufacturing.

Requirements

• Master’s degree in Microbiology and Immunology, Biomedical Engineering, or a related STEM field, or a foreign equivalent plus 2 years post-baccalaureate experience in job offered or any engineering/biomedical engineering related job titles.
• 2 years of experience in cell culture.
• 2 years of experience in cGMP manufacturing operations for commercial operations.
• 2 years of experience in Aseptic processing.
• 2 years of experience in troubleshooting manufacturing processes.
• 2 years of experience in design of experiments.
• 2 years of experience in project management and resource planning for commercial operations.
• 2 years of experience in risk-assessment techniques, including FMEA.
• 2 years of experience in Lean Manufacturing for commercial operations.
• 2 years of experience in statistical analysis and process controls.
• 2 years of experience in technology transfer.

Responsibilities

• Guide the Manufacturing and MS&T team for tech transfer and production of clinical and commercial cell therapy products.
• Interface with internal/external partners and develop technology transfer plans.
• Evaluate and implement process improvement effects.
• Coordinate and oversee production operations and support QC and QA testing.
• Troubleshoot instruments and assays, investigate deviations, and support product disposition evaluations.
• Lead the manufacturing of client cell therapy products for clinical and commercial supply.
• Oversee implementation of capable processes for manufacturing.
• Manage the cell therapy manufacturing facility.
• Build strong technical Manufacturing and MSAT teams.
• Oversee operation of all cGMP cell therapy manufacturing suites.
• Support business development efforts through technical assessment and resource utilization analysis.
• Ensure Manufacturing and MSAT support for improving manufacturing success rates.
• Deliver cGMP-compliant cell products to clients according to project timelines and budget.
• Establish process and analytical knowledge transfer from partners to Manufacturing and QC.
• Identify risks and propel continuous improvements in development and manufacturing processes.
• Build a flexible Manufacturing and MSAT organization.
• Identify and establish new capabilities in technology transfers and process validation.
• Develop systems for effective knowledge sharing internally and with external partners.
• Ensure technical expertise to support regulatory filings and health authority questions.
• Collaborate with cross-functional teams to meet goals and responsibilities.
• Exercise technical discretion in experiments contributing to project strategies.
• Supervise 24 subordinates including Managers and Sr. Managers.

Benefits

• Compensation for position: $237,475-$260,000/year
• 10% domestic and international travel required to partner sites and RoslinCT UK facilities.

What This Job Offers

• Career Level: Senior
• Education Level: Master's degree
• Number of Employees: 251-500 employees