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Thermo Fisher Scientific Manufacturing Responsible System Owner (technical writer) Supervisor in Cambridge, Massachusetts

When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.

How will you make an impact?

The Supervisor oversees specialists who are responsible for multiple manufacturing systems. Supervisors manage the scope, capacity, and workload of their direct reports. Will have strong interpersonal, communication and collaboration skills responsible for implementation of manufacturing documentation including Master production records, standard operating procedures, work instructions, job aids, and learning documents. Oversees group support of operational readiness projects for support drug substance manufacturing. Specialist supervisors must have detailed technical knowledge of cell and gene therapy manufacturing.

What will you do?

  • Promote a culture of safe operations and implement safety improvements across manufacturing systems.

  • Author, review, and/or edit procedures and technical documents to support manufacturing process including standard operating procedures, work instructions, and batch records.

  • Participate in improvement plan for deviation reductions, CAPA implementation and promote Compliance.

  • Promote a culture of visibility and accuracy of the project schedule and update dashboards accordingly to highlight project status to critical milestones.

  • Actively participate on cross-functional manufacturing teams to advance projects goals and deliverables.

  • Coach new trainees to build skills so toward becoming effective system owners.

  • Owner/accountable for 2+ group systems (eg. scheduling, workflows, templates, etc.)

  • Owner/accountable for team scope, workload, and timelines

  • Client-facing review session coordinator. Management delegate for JLT as appropriate.

  • Technical and operational SME in multiple systems (eg. upstream or downstream)

  • Support and coordinate critical and non-routine operations.

How will you get here?

Education:

  • Minimum required education: Bachelor's degree with 6+ years of experience or Master's degree with 4+ years of experience

  • Preferred educational background in STEM field

Experience:

  • Minimum two-year relevant work experience in GMP environment

  • Technical writing experience

  • Experience working in two or more functional areas within pharmaceutical manufacturing or other highly regulated field preferred.

Knowledge, Skills, Abilities:

  • Demonstrated written and verbal communications skills

  • Ability to foster a collaborative work environment

  • Ability to learn new software and tools quickly.

  • Demonstrated leadership, interpersonal, technical aptitude, and problem-solving skills

  • Ability to function in a dynamic environment and balance multiple priorities simultaneously.

  • Ability to learn new software and tools quickly.

  • Ability to make decisions and work with minimal supervision.

  • Ability to aseptically gown and/or sterile gown.

At Thermo Fisher Scientific, each one of our 80,000 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.

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

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