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Lead Analytical Scientist

2 months ago

Coventry, Rhode Island, United States Pharmaron Full time

We are seeking a Lead Analytical Scientist to become a vital part of our team at Pharmaron. In this role, the Lead Scientist will facilitate manufacturing and process chemistry operations through the development, optimization, validation, and transfer of analytical methodologies, ensuring adherence to all relevant regulations.

Key Responsibilities:

  • Execute all designated tasks promptly and systematically, in line with cGMP, GLP, and organizational protocols.
  • Maintain exceptional quality in analytical outputs and meticulously document all pertinent information clearly and concisely, adhering to cGMP standards.
  • Collaborate effectively with both internal and external stakeholders to address and resolve analytical challenges.
  • Design, enhance, and validate robust analytical techniques that are compliant with GMP principles, employing a quality-by-design approach while documenting formal protocols and reports.
  • Engage in method transfer initiatives, including the preparation of protocols and reports.
  • Conduct stability assessments and data analysis as necessary.
  • Review experimental findings, laboratory notebooks, and instrument qualification documentation.
  • Actively contribute to investigations, problem-solving, and troubleshooting efforts, including the preparation of investigation reports.
  • Summarize and present data findings (both written and oral) as required, effectively communicating critical analytical issues and proposed solutions to cross-functional teams.
  • Draft, revise, develop, and assess Standard Operating Procedures (SOPs).
  • Operate and maintain all analytical instruments and equipment in accordance with established guidelines.
  • Foster open communication within the team to share information, optimize resource utilization, and enhance operational efficiency.
  • Provide mentorship and support to fellow team members.
  • Assist in the identification and qualification of active pharmaceutical ingredient (API) impurities and degradation products.
  • Uphold excellent laboratory practices in compliance with safety and environmental regulations.
  • Demonstrate the ability to thrive in both collaborative and independent work environments.
  • Undertake additional related tasks and responsibilities as assigned.
Qualifications and Experience:
  • Possess a PhD in Analytical Chemistry with over 6 years of experience in pharmaceutical analysis, including proficiency with instrumentation such as HPLC, GC, FTIR, UV, LC/MS, and wet chemistry techniques.
  • Familiarity with NMR, ICP-MS, XRPD, DSC-TGA, LC/MS, and/or GC/MS is preferred.
  • Exhibit excellent verbal and written communication skills.
  • Proficient in managing multiple competing priorities and meeting deadlines.
  • Ability to work effectively in a cross-functional team environment.
  • Working knowledge of cGLP/cGMP and relevant FDA, EMA, and ICH guidelines is advantageous.
  • Possess a strong awareness of innovative technologies and the adaptability to meet internal requirements.