Senior Scientist, Process Development jobs in United States
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CHEManager International · 1 hour ago

Senior Scientist, Process Development

MilliporeSigma in Madison, WI, is looking for a Senior Scientist in Process Development. This role involves designing and leading the development of robust processes for manufacturing pharmaceutical intermediates and APIs while overseeing junior scientists and managing multiple projects.

Responsibilities

Design and lead the development of robust processes for manufacturing pharmaceutical intermediates and APIs, ensuring compliance with FDA, OSHA, EPA, DNR, DOT, and other regulatory agency guidelines
Develop successful processes through hands-on lab work while overseeing the efforts of junior scientists, mentoring them in the Process and Analytical Development (PAD) organization
Act as the technical team leader, participating in all project team activities and simultaneously managing 2-3 projects at various stages of maturity
Demonstrate a thorough understanding of modern analytical techniques to interpret spectra and data, providing innovative solutions to technical and analytical challenges during process development and cGMP manufacturing
Oversee process transfer to production labs, providing technical support for troubleshooting activities, process validation, and post-validation efforts
Prepare comprehensive process development reports for clients and internal use, ensuring effective documentation of process development activities
Display strong customer-facing communication skills to instill client confidence and demonstrate effective written communication skills
Act as a consultant for process and analytical development issues, completing projects with minimal guidance and proactively considering quality, regulatory, manufacturing, and safety requirements in project planning
Author, utilize, and train employees on written procedures, including batch records and operating procedures, while adequately documenting experimental data in electronic formats
Actively participate in or lead initiatives within PAD and the organization, showcasing scientific problem-solving skills and the ability to identify critical issues in experimental work

Qualification

Organic ChemistryProcess ChemistryAnalytical TechniquesRegulatory ComplianceHigh-Potency APIsExperimental DesignStatistical AnalysisMS Office 365MS ProjectChemOfficeCommunication SkillsOrganizational Skills

Required

PhD in Organic Chemistry, Chemistry or other Scientific discipline
Master's degree in Organic Chemistry, Chemistry or other Scientific discipline with 3+ years of experience in process chemistry
Bachelor's degree in Organic Chemistry, Chemistry or other Scientific discipline with 5+ years of experience in process chemistry

Preferred

PhD in Organic Chemistry with 1-2 years of experience in industry, including process chemistry and regulatory experience
Experience supporting a commercial program
Experience in handling High-Potency APIs
Knowledge of experimental design techniques and thermal hazard evaluation techniques in the process development field
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

Benefits

Health insurance
Paid time off (PTO)
Retirement contributions
Other perquisites

Company

CHEManager International

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Wiley’s leading media brand providing first-hand information on the global chemical, life science and process industries

Funding

Current Stage
Growth Stage
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