Thermo Fisher Scientific Job - 30693904 | CareerArc
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Company: Thermo Fisher Scientific
Location: Cambridge, MA
Career Level: Director
Industries: Healthcare, Pharmaceutical, Biotech

Description

Job Description

Position Summary:

Reporting to the GM/VP Viral Vector Services (VVS), the Director of Drug Product (DP) will oversee fill/finish operations across the VVS business unit, including Alachua (FL), Cambridge (MA), Lexington (MA), and future expansion spaces. The qualified individual will be responsible for optimizing and standardizing Fill/Finish-Drug Product operations to meet current/emerging regulatory expectations while building differentiating expertise across the network and executing client programs to meet their clinical and commercial needs.

In partnership with site GMs, the qualified person will oversee Drug Product for VVS and actively lead a growing team of employees in Florida and Massachusetts. The qualified individual will provide strong leadership and guidance, along with operational and scientific oversight to the Drug Product teams. The Director DP works closely with the site GM's to enhance fill/finish operations and will develop and drive the innovation agenda. In addition, he/she will collaborate with clients and the process development team to ensure the processes employed maximize yield/purity of the final drug product.

This executive is responsible for setting and delivering the DP strategy for VVS and meeting revenue/profitability targets and forecasts. The individual is responsible for all aspects of designing, developing and implementing scalable/reproducible fill/finish processes for viral vectors and ensuring these are suitable for use in clinical trials and commercial production. In addition, this position develops budgets for labor and capital expenditures, assigns experts to capital project teams, and approves, from a delivery perspective, early to late phase/commercial DP proposals being made to customers.

The Director, DP frequently partners with the VVS leadership team particularly around Manufacturing, Quality, EHS, Commercial Ops, and Client Program Management. In addition, this leader interacts directly with our clients and potential clients providing expertise and guidance on programs and helping to resolve escalation issues.

Key Responsibilities:

  • Oversee Drug Product operations for VVS, ensuring operations are safe, compliant and efficiently managed
  • Responsible for the development of the DP strategy across VVS, program timelines, and budgets
  • Works closely with leadership to identify and prioritize opportunities and drive business results
  • Change agent: encourages new ideas, processes and approaches. Champions and enables a culture of technical excellence, multidisciplinary problem solving, teamwork, consistency, flexibility, execution, quality and effective communication
  • Embraces and implements practical process improvement (PPI) initiatives.
  • Engages with and leverages expertise and experience from Drug Product divisions in the Pharma Services Group.
  • Hire and develop leaders & employees within the department in support of multi-site objectives. Assign work, provide feedback and coaching, shifting priorities and resources, as needed
  • Responsible for providing technical leadership to principal scientists, process engineers, scientists, and associates in the laboratories for clinical and commercial stage products.
  • Coordinate technology transfers (from clients, and within and from other VVS sites) to ensure effective information flow, timeline execution, issue resolution, and documentation for cross-functional teams
  • Make decisions, based on the professional judgment, experience, budget, cGMP regulations, and the ethical guidelines of good business practices.
  • Represents or assigns a subject matter expert on CMC teams and sub-teams to coordinate multi-functional activities for clinical and commercial programs
  • Proactively develop and sustain strong relationships with current customer accounts and contractual services suppliers to the unit
  • Work with internal stakeholders in Manufacturing, Quality, Client Program Management, etc. to facilitate successful customer management
  • Collaborate with Quality Head to ensure GMP practices, and implementation of controls
  • Must stay current with relevant technologies and forward thinking to identify new approaches. Implement as appropriate. Is expected to present at relevant conferences and meetings.

Minimum Requirements/Qualifications:

  • B.Sc. in Engineering or Science discipline, preferably with an advanced degree
  • A minimum of 15+ years of experience in commercial Drug Product operations engaged in the manufacture of parenteral biologics, preferably with gene therapy/viral vector product experience.
  • 5+ years in a leadership role overseeing complex operations; experience in commercializing a biologic product; tech transfer, PPQ and CQV.
  • Strong interpersonal and communication skills, verbal and written.
  • 30%+ Travel Required.

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.



If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here for further assistance.

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.


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