Eurofins PSS Insourcing Solutions
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If you're experienced in pharmaceutical formulations or chemistry manufacturing and controls, but you're interested in transitioning into a non-lab, regulatory affairs role, this is a great opportunity for a career pivot!
Job Description
Leads preparation, technical, and regulatory review and finalization of CMC sections for global CTA submissions. Takes a proactive role in the critical review of molecule-specific GRA-CMC development strategies and submission content. Makes technical decisions on CMC regulatory issues impacting product submissions across geographies, with support or guidance from Client GRA-CMC regulatory scientists. Provides high-quality, timely, and clear regulatory advice to enable CMC teams to make well-informed decisions. Evaluates regulatory impact on proposed CMC development plans. Communicates effectively, both verbally and in writing, to influence within GRA-CMC and with the CMC development team. Partners with Client GRA CMC (regulatory scientists) to develop complex regulatory strategies. Collaborates with Client RDE (regulatory associates/publishing group) to ensure completion of submission activities. Qualifications
Minimum Qualifications: Bachelor’s Degree in a science discipline (chemistry, biology, biochemistry, or related). Three to five years in research and development or formulation roles focused on large molecule/biologics drug substance/product development. Experience in pharmaceutical industry CMC technical drug development (drug substance and/or drug product, analytical development, or formulation). Preferred but Optional: Three or more years of direct global regulatory CMC experience, or equivalent supporting CMC functions during clinical trial phases in regions including US, EU, and Asia. Additional Information
Full-time position, Monday-Friday, 8:00 a.m. - 5:00 p.m., with overtime as needed. Candidates residing within a commutable distance of Indianapolis, IN are encouraged to apply. Comprehensive benefits including medical, dental, vision, life, and disability insurance. 401(k) with company match, paid vacation, and holidays. Authorization to work in the US without restrictions or sponsorship. Eurofins USA PSS Insourcing Solutions is an Equal Employment Opportunity employer supporting Disabled and Veteran applicants. Additional Details
Seniority level: Entry level Employment type: Full-time Job function: Science Referrals can double your chances of interview success. Get notified about new Formulation Scientist jobs in
Indianapolis, IN .
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Leads preparation, technical, and regulatory review and finalization of CMC sections for global CTA submissions. Takes a proactive role in the critical review of molecule-specific GRA-CMC development strategies and submission content. Makes technical decisions on CMC regulatory issues impacting product submissions across geographies, with support or guidance from Client GRA-CMC regulatory scientists. Provides high-quality, timely, and clear regulatory advice to enable CMC teams to make well-informed decisions. Evaluates regulatory impact on proposed CMC development plans. Communicates effectively, both verbally and in writing, to influence within GRA-CMC and with the CMC development team. Partners with Client GRA CMC (regulatory scientists) to develop complex regulatory strategies. Collaborates with Client RDE (regulatory associates/publishing group) to ensure completion of submission activities. Qualifications
Minimum Qualifications: Bachelor’s Degree in a science discipline (chemistry, biology, biochemistry, or related). Three to five years in research and development or formulation roles focused on large molecule/biologics drug substance/product development. Experience in pharmaceutical industry CMC technical drug development (drug substance and/or drug product, analytical development, or formulation). Preferred but Optional: Three or more years of direct global regulatory CMC experience, or equivalent supporting CMC functions during clinical trial phases in regions including US, EU, and Asia. Additional Information
Full-time position, Monday-Friday, 8:00 a.m. - 5:00 p.m., with overtime as needed. Candidates residing within a commutable distance of Indianapolis, IN are encouraged to apply. Comprehensive benefits including medical, dental, vision, life, and disability insurance. 401(k) with company match, paid vacation, and holidays. Authorization to work in the US without restrictions or sponsorship. Eurofins USA PSS Insourcing Solutions is an Equal Employment Opportunity employer supporting Disabled and Veteran applicants. Additional Details
Seniority level: Entry level Employment type: Full-time Job function: Science Referrals can double your chances of interview success. Get notified about new Formulation Scientist jobs in
Indianapolis, IN .
#J-18808-Ljbffr