Design and manage analytical approaches to support process development with a focus on chromatographic and dissolution-based methods.Oversee and review the planning development execution and interpretation of analytical studies performed by other scientists in a collaborative matrixed environment.Lead the development validation and transfer of robust analytical methods ensuring high-quality data generation and reproducibility.Manage stability studies to assess degradation pathways and establish shelf-life parameters.Develop impurity control strategies to ensure product quality and regulatory compliance.Collaborate cross-functionally to identify and apply optimal analytical techniques including 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.Maintain compliance with GLP / GMP standard and safety protocolsTechnical Expertise :
- Extensive hands-on experience with HPLC / UPLC dissolution testing and data review in a pharmaceutical R&D setting.
- Familiarity with a broad range of analytical techniques including SFC disintegrations compendial testing (e.g. excipients packaging release testing) generic testing (e.g. UV ICP-MS titrations)
- Proficiency in analytical instrumentation and troubleshooting
Qualifications :
Basic Qualifications :
- PhD in Chemistry or related field with 3 years of pharmaceutical R&D experience or a B.S. / M.S. with 15
- Strong oral and written communication skills.
- Experience in a regulated laboratory environment (GLP / GMP).
- Proven ability to mentor team members.
Preferred Qualifications :
- Familiarity with regulatory documentation and submission processes (e.g. IND NDA CTD)
- Experience with data visulization and modeling tools to support analytical decision making.
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
Key Skills
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Experience : years
Vacancy : 1