Downstream Manufacturing Manager at Thermo Fisher Scientific in Lexington, MA

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.

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.

Location:

Lexington, MA - Viral Vector Services Group

How will you make an impact?

The successful candidate will provide leadership and oversite of the Downstream Manufacturing Group 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 technology transfer of client processes for GMP manufacturing.

What will you do?

• Manage Downstream Process operations that include chromatography, tangential flow filtration, depth filtration and aseptic processing operations.

• 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

How will you get here?

Education

• High School Diploma or equivalent - required.

• Bachelor's Degree in Business or Life Sciences - preferred.

Experience

• Minimum of 8 years industry experience in aseptic processing, chromatography, tangential flow filtration and other purification processes.

• Minimum of 2 years of management and people leadership experiencepreferred

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).

• Manage teams consisting of multiple levels of exempt and non-exempt employees

• 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

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon.