Job Title: Sr. Manager

How will you make an impact?
The Manufacturing Sciences and Technology (MST) Senior Manager will be responsible for leading all facets of Process Validation, GMP Manager Floor Support, and Continued Process Verification in accordance with current good manufacturing practices (cGMP) for Viral Vector Services (VVS) Cambridge, MA clinical and commercial facility. He/she will provide strong leadership and scientific oversight to the MST team to ensure robust and reliable production processes are established thru a rigorous tech transfer process all to enable the site to meet and/or exceed client delivery commitments.

This role will drive the planning, execution and customer interaction for the MST function during technology transfer from Process Development (PD) or Process Sciences (PS) through to Commercial manufacturing programs. He/She will be responsible for all aspects of implementing, validating, and monitoring robust and efficient manufacturing processes to produce human clinical trial and commercial products. In addition, this position will develop budgets for labor, operating and capital expenditures.

Location:
Cambridge, MA

What will you do?
• Ensure the safety of assigned areas and work practices in accordance with site and company EHS programs.
• The design and execution of studies, investigation and data analysis of results, and writing/review of technical reports. Must stay current with relevant technologies and forward Provide technical leadership to process engineers, scientists, and associates for late stage clinical and commercial stage products including overseeing thinking to identify new approaches.
• Recruit and develop staff to execute department functions; ensure effective utilization of resources through strong people leadership including consistent performance management, robust employee development and routine rewards and recognitions practices.
• Establish department / individual goals and key performance indicators in alignment with company and operational goals; maintain and report applicable department and delivery metrics.
• Manage Technology Transfer from Process Development, Process Sciences and/or Client to commercial Manufacturing ensuring effective information flow, timeline execution, issue resolution, and documentation in accordance with governing tech transfer quality system requirements while leveraging robust risk management practices.
• Define and implement the procedures, systems, and practices for new product introduction, process validation, and continuous process verification in accordance with cGMP and ICH guidelines and industry best practices.
• Ensure robust strategies and approaches for facility fit and process gap analyses and risk assessments in support of process definition and improvement.
• Represent VVS as an SME during external and internal regulatory compliance inspections. Participate in writing, reviewing and approving CMC sections of US and international clinical trial applications, regulatory question responses, supplemental biologics license applications and international variations
• Proactively develop and sustain strong relationships with clients and services suppliers. Partner with internal stakeholders and cross-functional / cross site teams to facilitate successful customer management.
• Represent MST in daily Cambridge Site Cross-Functional leadership meetings.
• Partner with Finance to develop and maintain the Cambridge Site MST Budget for labor, operating and capital expenditures.

How will you get here?
Education
• Bachelor's degree in Biochemical Engineering or Biological Sciences, or related field – required.

Experience
• 7+ yrs. hands on experience in Manufacturing Sciences of vaccines and/or biologics, preferably with cell therapy and/or gene therapy product experience.
• 5+ years leading sciences / technology groups in a fast-paced production environment.
• Preferred experience in building, implementing, and managing a Manufacturing Sciences function.
• Expertise in cell culture-based manufacturing, tech transfer, investigations, and process validation of commercial-scale human therapeutics.
• Experience managing internal and external customers (i.e. Clients) including demonstrated rational persuasion.

Knowledge, Skills, Abilities
• Demonstrated people management and organizational skills; ability to prioritize and manage through complex processes/projects.
• Ability to analyze, interpret and compile data, define problems, establish facts, draw valid conclusions and make decisions.
• Ability to deal with abstract and concrete variables in situations with limited standardization.
• Hands-on experience in designing and implementing multi-variable experiments to evaluate processes, analytical methods, and formulations
• Understanding of guidelines required by FDA, EMA, and other regulatory bodies
• Excellent troubleshooting skills and ability to solve complex technical issues
• Strong interpersonal and communication skills, verbal and written

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.