Formulation Scientist

ZipRecruiter; Indianapolis (IN); On-site; USD 70,000 - 110,000; Full time

Job summary

An established industry player is seeking a skilled professional to transition into regulatory affairs from a scientific background. This role involves leading the preparation and review of critical CMC submissions, ensuring compliance with global regulations. The ideal candidate will leverage their experience in pharmaceutical formulations to provide high-quality regulatory guidance, impacting product development across various geographies. With a focus on collaboration and communication, this position offers a unique opportunity to influence regulatory strategies within a dynamic team environment. Join a forward-thinking company that values innovation and professional growth.

Benefits

Comprehensive Medical Coverage

Dental Insurance

Vision Insurance

Life Insurance

401(k) with Company Match

Paid Vacation

Paid Holidays

Qualifications

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

Responsibilities

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

Skills

Regulatory Affairs

Pharmaceutical Formulations

Technical Review

CMC Development Strategies

Communication Skills

Education

Bachelor’s Degree in Science

Job description

Job Description

Company 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

• Lead preparation, technical, and regulatory review and finalization of CMC sections for global CTA submissions.
• Take a proactive role in the critical review of molecule-specific GRA-CMC development strategies and submission content.
• Make 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 enable CMC teams to make well-informed decisions.
• Evaluate regulatory impact on proposed CMC development plans.
• Communicate effectively verbally and in writing to influence within GRA-CMC and with CMC development teams.
• Partner with Client GRA CMC (regulatory scientists) to develop complex regulatory strategies.
• Collaborate 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 roles focused on large molecule/biologics drug substance/product development.
• Experience in the pharmaceutical industry in CMC technical drug development (drug substance and/or drug product experience in analytical development or formulation).

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.
• Benefits include comprehensive medical coverage, dental, vision, life 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 an Equal Employment Opportunity employer supporting Disabled and Veteran applicants.