Overview In this role you drive analytical excellence in the Coventry, RI QC lab, enabling API manufacturing and development through validated methods and rigorous data review. You will troubleshoot complex analytical challenges, guide method transfer and QA-aligned documentation, and support regulatory inspections. You join a cross-functional team to enhance QC capabilities and sustain GMP-compliant operations. This position offers impact across discovery to manufacturing, with growth through mentorship and process improvements.
Compensation / Benefits- Comprehensive Medical, Dental & Vision Insurance
- 401(k) with employer matching
- Generous PTO, sick leave, and holidays
- Employer-funded HSA contributions
- Life Insurance, AD&D, disability insurance
- Employee Assistance Program and wellness resources
Responsibilities- Support analytical method validation, verification, and transfer within the QC lab
- Troubleshoot complex analytical challenges related to API characterization and GMP testing
- Review analytical data, notebooks, and instrument qualification documentation for accuracy and regulatory compliance
- Lead or support laboratory investigations, deviations, and root cause analyses
- Maintain laboratory equipment and act as system owner for analytical instrumentation (qualification and maintenance)
- Provide technical mentorship to QC scientists and laboratory personnel
- Prepare and revise SOPs, analytical methods, and technical documentation
- Support regulatory inspections and client audits as analytical SME
- Collaborate with Manufacturing, Process Chemistry, Quality Assurance, and Regulatory Affairs
- Contribute to continuous improvement initiatives for QC efficiency and analytics
- Perform other related assignments as required
Key requirements- Ph.D. in Chemistry or related field with 1-3 years postdoctoral/industry experience OR MS with 4-7 years in pharma OR BS with 5-8 years in pharma
- 3 years of experience with core analytical instrumentation (HPLC/UPLC, GC, FTIR, UV, MS)
- Experience applying analytics to method validation, troubleshooting, and implementation
- Hands-on expertise with HPLC/UPLC, GC, FTIR, UV, MS
- Experience in API manufacturing or pharma QC labs
- Proven ability to troubleshoot instrumentation and methods
- Working knowledge of cGLP/cGMP and FDA/EMA/ICH guidelines
- Experience contributing to multidisciplinary teams; mentoring preferred
- Strong analytical thinking, scientific judgment, and communication skills
- analytical thinking
- problem-solving
- communication
- HPLC/UPLC
- GC
- FTIR
