Formulation Scientist

Eurofins PSS; Indianapolis (IN); On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a dedicated professional to pivot into regulatory affairs. This full-time role offers a chance to lead the preparation and review of CMC sections for global submissions, ensuring high-quality regulatory advice for CMC teams. With a focus on large molecule drug development, you'll collaborate with scientists and associates to navigate complex regulatory strategies. Enjoy excellent benefits and a supportive work environment while contributing to impactful projects in the pharmaceutical industry.

Benefits

Comprehensive Medical Coverage

Dental and Vision Options

Life and Disability Insurance

401(k) with Company Match

Paid Vacation and Holidays

Qualifications

• 3-5 years in R&D or formulation role focused on large molecule/biologics.
• Pharmaceutical industry experience in CMC technical drug development.

Responsibilities

• Lead preparation and regulatory review of CMC sections for global submissions.
• Provide high-quality regulatory advice to CMC teams.

Skills

Regulatory Affairs

Pharmaceutical Formulations

CMC Development

Technical Review

Communication Skills

Education

Bachelor’s Degree in Science

Job description

If you're experienced in pharmaceutical formulations or chemistry manufacturing and controls, but you're interested in taking your career into a non-lab, regulatory affairs space, 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.
• Provide high quality, timely and clear regulatory advice to allow CMC teams to make well-informed decisions
• Evaluate regulatory impact on proposed CMC development plans
• Communicates effectively verbally and in writing to influence within GRA-CMC and with CMC development team.
• Partners with Client GRA CMC (regulatory scientists) develop complex regulatory strategies.
• Partners 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 scientific discipline).
• Three to five years in research and development or formulation role focused on large molecule/biologics drug substance/product development.
• Pharmaceutical industry experience in CMC technical drug development (drug substance and/or drug product experience in analytical development or formulation).

Preferred but Optional:

• Three or more years of direct global regulatory CMC experience, or equivalent experience supporting CMC functions contributing to clinical trial phases of development in various regions, including US, EU, and Asia.

Additional Information

• Position is full-time, working Monday-Friday 8:00 a.m.-5:00 p.m, overtime as needed
• Candidates currently living within a commutable distance of Indianapolis, IN are encouraged to apply.
• Excellent full-time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays
• Authorization to work in the United States indefinitely without restriction or sponsorship

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Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.