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MilliporeSigma · 23 hours ago

Tech Transfer Scientist, Technical Ops

Madison, WI

Full-time

Onsite

Mid Level

$74K/yr - $122K/yr

4+ years exp

MilliporeSigma is a global company focused on innovating with science and technology to enhance lives in Healthcare, Life Science, and Electronics. The Tech Transfer Scientist is responsible for overseeing process transfer and scale-up activities, ensuring compliance with cGMP and regulatory requirements while leading project teams and managing production projects.

BiotechnologyMedicalMedical Device

No H1B

Responsibilities

Lead project teams and manage 2–3 concurrent production projects, serving as the technical point of contact for Technical Operations

Collaborate with management on development and implementation of innovative technologies

Independently complete projects or engage subject matter experts to resolve technical challenges

Participate in client meetings and deliver comprehensive technical transfer reports for both internal and external use

Provide production support for first-time GMP and commercial API processes

Develop and execute procedures for continuous process monitoring in production

Lead technology and documentation transfer, author and train staff on batch records, SOPs, and operating procedures

Ensure compliance with FDA, OSHA, EPA, DOT, DNR, and other regulatory requirements while maintaining accurate cGMP documentation

Contribute to regulatory filings and responses as part of the technical regulatory support team

Qualification

CGMP manufactureAPI manufacturingProject leadershipChemical manufacturingOrganic chemistryData analysisScientific problem-solvingMS Office 365ChemOfficeCommunicationOrganizational skills

Required

Bachelors Degree in Chemistry, Biochemistry, Chemical Engineering, or other Life Science discipline

4+ years experience in chemical manufacturing

Preferred

Experience in API manufacturing

Experience in production in fixed equipment of 200 L or larger

Experience in handling High-Potency APIs is a plus

Experience with multiple step chemical syntheses and thorough understanding of organic chemistry

Experience with scaling process from gram quantities to multi-kilogram quantities

Scientific problem-solving skills, including the ability to identify critical issues in experimental work and to suggest possible solutions

Knowledge and understanding of the overall goals, implementation and application of cGMP and other relevant quality systems

Superior organizational skills and the ability to multi-task proficiently

Excellent communication skills, including the ability to give presentations and to speak to large groups. The ability to establish rapport with non-technical parts of the company as well

Proficient in use of standard office computers as well as software for laboratory work (data capture, data analysis, etc.) and statistical analysis. Specifically, MS Office 365, MS Project, ChemOffice, etc