Analytical Project Lead
Analytical Project Lead
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
- Work in a GLP or GMP environment with appropriate documentation and safety practices
- Lead the development and execution of analytical strategies for new drug product candidates
- Plan direct and review laboratory work including method development validation and transfer
- Design and interpret stability studies to understand degradation mechanisms and support shelf-life assignments.
- Develop impurity control strategies aligned with regulatory expectations.
- Collaborate with formulations process and regulatory teams to ensure seamless pharmaceutical drug development
- Collaborate with colleagues to identify appropriate analytical approaches including use of computational predictive tools modeling software and data visualization tools where appropriate
- Critically review and interpret scientific data to derive clear conclusions and provide direction for future work
- Mentor and guide junior scientists in analytical techniques and data interpretation.
- Evaluate and implement new strategies as needed e.g. working with external partners
- Communicate results and conclusions through various media including presentations and technical reports
- Author relevant sections of the quality modules of regulatory submissions
Qualifications :
- Ph.D. in Analytical Chemistry or related field with 5-7 years of pharmaceutical R&D experience or B.S./M.S. with 15 years of pharmaceutical R&D experience required
- Authorization to work in the United States indefinitely without restriction or sponsorship
- Proven expertise in a broad range of analytical techniques e.g. chromatography mass spectrometry dissolution spectroscopy NMR and data analysis
- Strong understanding of regulatory requirements and experience with regulatory filings
- Experience with method transfer and working with external partners
- Proficiency in scientific software data systems and modeling tools
- Demonstrated leadership problem-solving and mentoring capabilities
Desired Qualifications:
- Experience with mathematical modeling or coding
- Candidates currently living within a commutable distance of Groton CT are encouraged to apply
Additional Information :
- Position is full-time Monday-Friday 8:00 am - 5:00 pm.
- 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
- #LI-EB1
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
