Manager, Upstream Manufacturing - Nights

Location: Lexington, MA

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 necessary to help clients deliver innovative gene therapies. Placed in the forefront of our leading and cutting edge Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases.

The Manufacturing Manager will manage and lead a team of manufacturing Supervisors and their associated teams in the Upstream Manufacturing Group for cGMP viral vector production operations. The successful candidate will ensure that the department maintains proper training and compliance to cGMP standards and ensure production schedule adherence. Manager will ensure conduct and performance of direct reports to Thermo Fisher Scientific corporate standards. A typical work week will be Monday through Friday evening hours to manage GMP manufacturing operations.

How will you make an impact?

The successful candidate will provide leadership and oversite of their respective department as well as the manufacturing process operations including discrete critical process steps. The manager will be expected to coach and mentor staff in all aspects of their job performance and career development including training, performance management and feedback, rewarding excellence, and taking disciplinary action when necessary. The manager will be expected to support and facilitate technical transfer of client processes for GMP manufacturing.

What will you do?

• Provide leadership and oversite for phase III and commercial manufacturing upstream operations that include cell passages along with suspension and adherent bioreactor systems.
• Establish goals for department and individuals and monitor performance via regular 1:1 meetings and regular performance review cycles.
• The Manager will initiate, review and approve deviations, initiate and review and approve CAPAs, act as area and equipment owner for change controls and support development and writing of operational SOP’s and Production Batch Records.
• Other responsibilities include managing projects and technology transfers and working closely with related functional areas to achieve production goals and timelines.
• Review and approve batch records, SOP’s and associated documentation in support of campaign start up.
• Develop work plans, assign tasks and manage a large team or multiple small teams
• Participate in developing site metrics

How will you get here?

• Ability to function in a fast paced, dynamic environment with multiple priorities simultaneously
• Strong planning, organization and multitasking skills
• Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.
• Ability to make decisions and work with minimal to moderate supervision.
• Able to provide effective written or verbal communication to peers, senior associates, and area management within their operational groups in support of investigations, project updates and team performance

Education

• HS Diploma or equivalent - required.
• Bachelor’s Degree in Business or Life Sciences- preferred. A combination of education and experience will be considered.

Experience

• Minimum of 8 years’ industry experience in pharmaceuticals manufacturing
• Minimum of 2 years of management and people leadership experience preferred

Knowledge, Skills, Abilities

• Demonstrated ability to motivate non-exempt employees and demonstrated management skills, (i.e., business knowledge, leadership, communication, ability to analyze technical issues, conflict resolution).
• Thorough knowledge of cGMPs.
• Strong interpersonal and communications skills; written and oral
• Ability to function in a fast paced, dynamic environment with multiple priorities simultaneously
• Strong planning, organization and multitasking skills
• Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.
• Ability to make decisions and work with minimal supervision.
• Able to provide effective written or verbal communication to peers, senior associates, and area management within their operational groups in support of investigations, project updates and team performance

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.