Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materials

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner, and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Location/Division Specific Information:

This position will be site based in Plainville, MA and will support our Viral Vector Services (VVS Plainville) business unit of Thermo Fisher Scientific At Viral Vector Services (VVS) a division of Thermo Fisher Scientific, we offer an outstanding opportunity to work in our world-class Cell and Gene Therapy business.

Discover Impactful Work: 

The role encompasses various responsibilities, including production scheduling, investigating deviations, managing changes, handling documents, and providing training. The main objective is to ensure compliance with cGMP for late-stage clinical and commercial production. The position reports to the Sr. Manager Downstream, and requires a leadership approach that emphasizes critical thinking and achieving results, while maintaining high quality and safety standards.

The Manager, Downstream Manufacturing will implement operational excellence tools and systems to optimize cross-functional production flow and quality culture. The role requires collaboration across the organization to manage a fast-paced project and production environment and deliver excellent service to clients. You will lead cross-functional efforts, ensure operational efficiency, and support robust business processes for successful product planning, production, testing, and release.

A Day in the Life:

Safety & Compliance: Ensure the safety of all assigned areas, embedding strong safety practices in alignment with site and company Environmental Health & Safety (EHS) programs.

Quality Culture: Champion a culture of quality by maintaining compliance with global cGMP standards and accountability at all levels.

Production Coordination: Coordinate daily downstream production activities, ensuring efficient operations, compliance, and delivery of production schedules.

Collaborate with clients, manufacturing sciences, and program managers to ensure smooth technical transfer of client processes. This includes managing change controls, revising batch records and procedures, and establishing effective training programs.

Team Development: Recruit, onboard, and develop a high-performing team. Drive employee engagement through development plans, consistent performance management, and recognition programs.

Goal Setting & Metrics: Establish and monitor departmental goals and important metrics that are in alignment with company objectives. Regularly supervise and provide reports on progress.

Continuous Improvement: Lead initiatives to cultivate an Operational Excellence mentality, encouraging self-detecting and self-correcting processes. Persistently seek opportunities for improvement and innovation.

Risk Mitigation: Proactively identify and address quality, operational, and organizational risks, raising critical concerns as needed.

Keys to Success:

Education

Bachelor’s degree required, and a master's degree is preferred.

Experience:

4 years in management/leadership roles required.

3 years experience leading cGMP manufacturing/operations teams.

Requires 4-6 years of related experience working in a highly regulated enviroment with BS degree, or 2-4 years of experience accepted with a master’s degree.

Knowledge, Skills, Abilities:

Consistent track record to operate autonomously in a dynamic environment.

Strong analytical and problem-solving skills with outstanding attention to detail.

Demonstrated capability in cross-functional collaboration and team management.

Effective communication and negotiation skills, with the ability to present ideas persuasively.

Proficient in identifying and implementing process improvements.

Physical Requirements / Work Environment / Schedule

Ability to gown aseptically and/or sterile gown as required.

Capability to read, write, and review detailed documentation for extended periods.

Specific vision requirements: close vision, distance vision, color vision, peripheral vision, depth perception, and focus adjustment.

Occasionally required to lift, walk, use hands to handle or feel, reach with arms, and stoop or crouch.

The role currently follows a Monday through Friday schedule. However, we need candidates who are flexible and open to transitioning to a 12-hour rotating shift schedule in the future, based on evolving business needs.

Benefits

We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.