Viral Vector Services, Thermo Fisher Scientific

At Viral Vector Services (VVS), a division of Thermo Fisher Scientific, we deliver from process development through commercial supply, and we offer the expertise and resources necessary to help clients deliver innovative gene therapies. VVS is an experienced viral vector CDMO focused on process and analytical development. With more than a decade of experience, our 500-strong, highly skilled team has managed over 100 client projects delivering first-in-human clinical materials to accelerate our client's products from the laboratory to patients in need.
Location: Cambridge

How will you make an impact?
This position is responsible for leading the Cambridge site’s Drug Product (DP) Manufacturing operation inclusive of fill finish production, equipment prep and visual inspection as well as indirect operational / suite support activities including production scheduling, deviation investigation, change management, document management, and training all according to current good manufacturing practices (cGMP) in support of late stage clinical and commercial production. Reporting to the Site Head, he/she provides the leadership, strategic thinking, and results focus to reliably meet and/or exceed the site’s production targets while achieving high levels of quality and driving a strong safety culture. The DP Manufacturing head will define and deploy operational excellence tools and systems that empower cross functional production flow / value stream teams. This position requires an individual capable of partnering across the organization to manage a fast-paced production environment and deliver exceptional service to our clients.

You will provide the cross functional leadership, operations acumen, and results focus to reliably meet and/or exceed product supply targets while achieving high levels of quality. You will partner across the site to implement robust business processes to support the successful planning, production, testing, and release of product in a fast-paced production environment.

What will you do?

• Ensure the safety of assigned areas and work practices in accordance with site and company EHS programs.
• Provide daily management oversight for all DP production activities at Cambridge site ensuring processes and practices are compliant with global current good manufacturing practices (cGMP).
• Partner with clients, manufacturing sciences, and program managers to facilitate technical transfer of client processes to manufacturing including management of change controls, development / revision of batch records and procedures, and establishing process and equipment training programs.
• 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.
• Drive continuous improvement and Operational Excellence culture thru self-detecting and self-correcting processes and systems and instilling strong ownership and accountability.
• Develop and manage department’s annual operating budgets; partner with Finance to analyze variances and implement adjustments.
• Proactively identify, assess, and mitigate quality, operational, and organizational risks; escalate key risks and issues.

  How will you get here?

Ensuring high levels of communication with cross functional teams, and engaging in proactive relationships with client, including representing VVS’s operational interests in both tactical and strategic meetings.

Education

• Bachelor's degree and 6-8 years of related work experience or Master’s degree and 4-6 years of work experience. Minimum of 5 years in management / leadership positions.

  Experience

• Demonstrated ability to operate with minimal supervision in a fast paced environment.
• Demonstrated ability to present ideas persuasively and negotiate effectively.
• Minimum of 3 years leading cGMP manufacturing / operations teams in fast paced production environment.
• Demonstrated ability to manage cross-functional teams and collaborate across the business.

Knowledge, Skills, Abilities

• Strong analytical and problem-solving skills; great attention to detail and excellent decision-making process.
• Excellent written and oral communication skills

At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Apply today! http://jobs.thermofisher.com

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.