Thermo Fisher Scientific Sr Manager, Manufacturing Sciences in Cambridge, Massachusetts
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.
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?
- Bachelor's degree in Biochemical Engineering or Biological Sciences, or related field - required.
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 is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
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