Formulation Scientist - Eurofins PSS Insourcing Solutions : Job Details

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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!

• 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.

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.

• 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.

• Seniority level: Entry level
• Employment type: Full-time
• Job function: Science

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