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Thermo Fisher Scientific Upstream Manager in Plainville, Massachusetts

Job Description

At Viral Vector Services (VVS) a division of Thermo Fisher Scientific we deliver, from process development through commercial supply, we offer the expertise and resources to help clients deliver innovative gene therapies. Placed in the forefront of our leading and groundbreaking Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases.

  • The Upstream MS&T Manager is a professional in technical management and execution for late stage clinical and commercial gene therapy manufacturing from new product introduction through process performance qualification.

  • Upstream MST Managers lead a team responsible for Tech Transfer, Process Validation and Manufacturing support of Clinical and Commercial Programs.

  • Schedule production for the assigned manufacturing areas balancing at best demand and supply.

  • Own and deliver commitments including organic growth, profitability, share gain, and bookings for a sophisticated global business.

  • Responsible Quality oversight across 4+ Sites based on the interpersonal design that spans multiple countries.

  • Be responsible for and drive strategy for data management and analysis.

  • Author GMP documentation, such as, Master Batch Records, Protocols, Standard Operating Procedures, Risk Assessments, etc, to support technology transfer and commercial production.

  • Identify and drive large and sophisticated continuous improvement projects as part pf the PPI initiative.

  • Success in this role means that patients will receive an entire new generation lifesaving gene therapy medication!

How you will make an impact!

  • Provide technical leadership to process engineers, scientists, and associates for late stage clinical, process validation and commercial stage gene therapy products.

  • Lead a team of process and manufacturing engineers to define and establish the manufacturing processes & production line

  • Minimum of 15+ years of progressive career growth and experience leading Engineering, or Process Development in a heavily regulated environment.

  • Guide technical documentation including tech transfer, investigations, and data analysis to support deviations and change controls.

  • Collaborate with partners to drive program success.

  • Be an authority in environment, health & safety.

The successful candidate will possess the following combination of education and experience:

Possesses a highly developed quality, regulatory and production mentality including an appreciation for contract manufacturing. Outstanding Good Manufacturing Practices knowledge. Proven decision-making capabilities. Well organized and detail oriented. Strong leadership and conflict resolution skills. Ability to balance/maintain conflicting goals, responsibilities, and priorities of the organization. Excellent interpersonal skills as well as the ability to motivate and lead. Experience with Microsoft Word and Excel. Proficiency in the English Language. Outstanding attention to detail and organizational skills. Self-starter, independent and diligent. Ability to work in a fast paced environment. Effective time management and prioritization skills. Very high degree of interpersonal skills to establish and maintain effective working relationships with employees and the public, including tact to handle critical matters. Highly effective verbal and written communication skills.

Education and Experience:

  • Bachelor’s degree in Engineering or equivalent (Electrical Engineering or Systems Engineering preferred) and a minimum of 2 years of related experience is required.

  • B.S. in Bioengineering, Biotechnology, Engineering or related field with 1+ years’ experience in system engineering or related field is preferred.

  • Experience to include 4+ years directly in FDA and EMA regulated manufacturing. Experience in manufacturing operations, engineering, MST roles is highly valued.

  • Ability to lead multiple technical requests with excellent communication to internal and external teams

  • Highly developed project management skills including shown ability to lead large matrix teams to deliver projects.

  • Confirmed leadership aptitude with excellent people management and organizational skills; ability to prioritize and manage through complex processes/projects.

  • Authority in Viral Vector or Biologics manufacturing including advanced technical topics in Upstream.

  • Extensive experience in FDA, EMA oversight including investigations, CAPA, Audits.

  • Must work well on a team and be able to trouble shoot and problem solve in a multi-functional team setting.

  • Great teammate with strong desire to success and result oriented.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.