Sr. Director - Manufacturing and MS&T chez None

Job Title: Senior Director of Manufacturing and MS&T

Approved Locations:  97 South Street, Hopkinton, MA 01748

Job Description:

Your day-to-day will include:

Apply 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. Interface directly with internal/external partners, develop and lead technology transfer plans, and evaluate and implement process improvement effects. 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. 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. Provide leadership oversight and build strong technical Manufacturing and MSAT teams at the Hopkinton manufacturing site and any future manufacturing sites. 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. Supervises 24 subordinates – Managers and Sr. Managers of MSAT and Manufacturing

You have the following technical skills and qualifications:

• Requirement - 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.
• Relevant experience - Applicants must possess 2 years of experience in the following: (1) cell culture; (2) cGMP manufacturing operations for commercial operations: (3) Aseptic processing; (4) Troubleshooting Mfg. processes; (5) Design of experiments; (6) project management and resource planning for commercial operations; (7) Risk-assessment techniques, including FMEA; (8) Lean Manufacturing for commercial operations; (9) Statistical Analysis & Process Controls; (10) Technology Transfer. 
• 10% domestic and international travel required to partner sites and RoslinCT UK facilities. 

Compensation for position: $237,475-$260,000/year