Formulation Scientist

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

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.

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

401(k) with Company Match

Paid Vacation

Paid Holidays

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

Referrals can double your chances of interview success. Get notified about new Formulation Scientist jobs in Indianapolis, IN.