- Design and guide analytical strategies to support manufacturing process development.
- Lead the planning development execution and data interpretation performed by other scientists in a collaborative matrixed environment.
- Oversee and review the development validation and transfer of analytical methods to ensure robust and reliable data generation.
- Manage stability studies to assess degradation pathways and establish shelf-life parameters.
- Develop impurity control strategies to ensure product quality and regulatory compliance.
- Experience with a wide range of analytical testing including dissolution HPLC/UPLC SFC disintegration compendial testing (e.g. excipients / packaging release testing) generic testing (e.g. solvents water ash titrations heavy metals ICP/MS UV) and compound specific methods
- Collaborate with cross-functional teams to identify and apply the most effective analytical techniques including the use of computational modeling predictive tools and data visualization platforms.
- Evaluate scientific data to draw clear conclusions guide future work and communicate findings through presentations technical reports and other media.
- Contribute to regulatory submissions by authoring relevant sections of the quality modules ensuring alignment with global standards and expectations.
- Maintain compliance with GLP/GMP standard and safety protocols
Qualifications :
- PhD in Chemistry or related field with 3 years of pharmaceutical R&D experience or a B.S./M.S. with 15 years
- Strong oral and written communication skills.
- Experience in a regulated laboratory environment (GLP/GMP).
- Proven ability to lead scientific projects and mentor team members.
- Proficiency in analytical instrumentation and techniques.
- Familiarity with regulatory documentation and submission processes.
Additional Information :
- Position is full-time Monday-Friday 8:00 am - 5:00 pm.
- Candidates currently living within a commutable distance of Groton CT 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
- #LI-EB1
- Authorization to work in the United States indefinitely without restriction or sponsorship
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
Remote Work :
No
Employment Type :
Full-time