Formulation Scientist

Eurofins PSS Insourcing Solutions; Indianapolis (IN); On-site; USD 60,000 - 95,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) with Company Match

Paid Vacation

Paid Holidays

Job summary

An established industry player is seeking an entry-level professional to join their regulatory affairs team. This full-time role offers a unique opportunity for those with a background in pharmaceutical formulations or chemistry to transition into a non-lab environment. You will lead the preparation and review of regulatory submissions, ensuring compliance and providing strategic guidance to teams. With a comprehensive benefits package and a supportive work environment, this position is perfect for individuals looking to make a significant impact in the pharmaceutical industry while advancing their careers.

Qualifications

• 3-5 years in R&D or formulation roles focused on large molecule/biologics.
• Experience in pharmaceutical industry CMC technical drug development.

Responsibilities

• Lead preparation and regulatory review of CMC sections for global submissions.
• Provide regulatory advice to enable informed decisions in CMC teams.

Skills

Regulatory Affairs

Pharmaceutical Formulations

CMC Development

Technical Review

Communication Skills

Education

Bachelor’s Degree in Science

Job description

1 week ago Be among the first 25 applicants

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

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