Formulations Manufacturing Manager

Thermo Fisher Scientific•Cincinnati, OH

About The Position

As part of Thermo Fisher Scientific, the Formulations Manufacturing Manager guides a collaborative team producing high-quality pharmaceutical and diagnostic products while ensuring compliance with cGMP standards and regulatory requirements. The role supports operational excellence through effective resource management, process optimization, and continuous improvement. It involves collaborating across teams to meet production goals, maintain quality standards, and deliver products on time, while fostering a culture of safety, quality, and innovation and developing team members’ capabilities and engagement. The position is based in a manufacturing environment that may include cleanroom conditions, loud equipment, rapid flashing lights, strong odors, and hazardous or toxic materials. Work requires adherence to GMP and safety standards and cleanroom gowning restrictions, along with use of personal protective equipment. The stated schedule is standard Monday through Friday, although the requirements note that various shifts, including nights and weekends, may be needed according to business needs. Relocation assistance is unavailable. Applicants must be legally authorized to work in the United States without current or future employer-sponsored work authorization. Employment is contingent on applicable pre-employment requirements, including background and drug screening.

Requirements

  • Advanced degree plus 6 years of experience, or a bachelor’s degree plus 8 years of experience in a cGMP manufacturing environment; pharmaceutical or diagnostic manufacturing experience is preferred.
  • At least 3 years of demonstrated management or leadership experience supervising manufacturing teams.
  • Strong understanding of cGMP regulations, quality systems, and regulatory compliance requirements.
  • Demonstrated success in operational excellence and continuous improvement initiatives.
  • Experience with manufacturing documentation, batch record review, and change control processes.
  • Ability to conduct investigations, implement CAPAs, and support quality improvements.
  • Strong project management and organizational skills to manage multiple priorities.
  • Skill in cross-functional collaboration and stakeholder management.
  • Strong verbal and written communication skills in English.
  • Proficiency with ERP systems, Microsoft Office, and quality management software.
  • Ability to work in cleanroom environments and comply with gowning requirements.
  • Ability to stand for extended periods and occasionally lift up to 25 lbs.
  • Ability to work various shifts, including nights and weekends, as business needs require.
  • Legally authorized to work in the United States without current or future employer-sponsored work authorization.
  • Successful completion of applicable pre-employment requirements, including background check and drug screening.

Nice To Haves

  • Preferred fields of study include Chemistry, Engineering, Life Sciences, or a related scientific or technical field.
  • Experience in pharmaceutical or diagnostic manufacturing.

Responsibilities

  • Guide a collaborative team in manufacturing pharmaceutical and diagnostic products.
  • Ensure compliance with cGMP standards and regulatory requirements.
  • Manage resources effectively and support process optimization and continuous improvement initiatives.
  • Collaborate across teams to meet production goals, maintain quality standards, and deliver products on time.
  • Support a culture of safety, quality, and innovation.
  • Develop team members’ capabilities and foster engagement.
  • Review manufacturing documentation and batch records and support change control processes.
  • Conduct investigations, implement CAPAs, and support quality improvements.
  • Manage multiple priorities and collaborate with stakeholders across functions.
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