Senior Formulations Scientist - Chemistry Manufacturing Controls
Senior Formulations Scientist - Chemistry Manufacturing Controls
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Position Overview:
Provide strategic tactical and operational support to expedite the development of clinical trial portfolios by developing regulatory strategies and submissions.
Job Responsibilities:
- Lead preparation review and finalization of CMC sections for global CTA submissions.
- Critically review moleculespecific GRACMC development strategies and submission content.
- Make technical decisions on CMC regulatory issues with guidance from Client GRACMC regulatory scientists.
- Provide clear regulatory advice to CMC teams.
- Evaluate regulatory impact on CMC development plans.
- Communicate effectively within GRACMC and with the CMC development team.
- Partner with Client GRACMC regulatory scientists to develop complex regulatory strategies.
- Collaborate with Client RDE regulatory associates to complete submission activities.
Qualifications :
Minimum Qualifications:
- Education: Bachelors degree in a science discipline (e.g. chemistry biology biochemistry).
- Experience: 35 years in R&D or formulation roles focused on large molecule/biologics drug development.
- Industry Experience: Experience in CMC technical drug development (analytical development or formulation).
Additional Information :
- Position is fulltime workingMondayFriday 8:00 a.m.5:00 p.m with overtime as needed
- Candidates currently living within a commutable distance of Indianapolis IN are encouraged to apply.
- Excellent fulltime benefits including comprehensive medical coverage dental and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
- #LIEB1
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
