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Lead Analytical Scientist

2 months ago

Coventry, Rhode Island, United States Pharmaron Full time
Position Overview

Pharmaron Manufacturing Services is seeking a Lead Analytical Scientist to join our dynamic team.

This role is essential in supporting production operations through the development, refinement, validation, and transfer of analytical methodologies, ensuring adherence to all relevant regulations and standards.


Core Responsibilities:

  • Execute assigned responsibilities promptly and systematically, aligning with cGMP, GLP, and organizational protocols.
  • Maintain exceptional quality in analytical tasks, meticulously documenting all pertinent information in a clear and concise manner as per cGMP standards.
  • Design, enhance, and validate robust analytical techniques that comply with GMP principles, utilizing a quality-by-design approach, and preparing formal documentation and reports.
  • Engage in method transfer processes, including the creation of protocols and reports.
  • Conduct stability assessments and data analysis as necessary.
  • Review experimental findings, laboratory notebooks, and equipment qualification documentation.
  • Actively contribute to investigations, troubleshooting, and problem resolution, including the preparation of investigation reports.
  • Compile and present data summaries, both written and verbal, to cross-functional teams, effectively communicating critical analytical challenges and solutions.
  • Draft, revise, and evaluate Standard Operating Procedures (SOPs).
  • Operate and maintain analytical instruments and equipment according to established protocols.
  • 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 exemplary laboratory practices in accordance with safety and environmental regulations.
  • Demonstrate the ability to thrive in both collaborative and independent work environments.
  • Perform additional related tasks and responsibilities as assigned.
  • Exhibit proven expertise in analytical method development and validation for small molecules.
  • Showcase scientific proficiency and the capability to conduct complex scientific investigations autonomously.
  • Effectively manage multiple competing priorities while adhering to timelines.
  • Adapt to a cross-functional working environment.
  • Maintain a high level of awareness regarding innovative technologies and adapt them to meet internal requirements.


Qualifications:

  • Master's degree in Analytical Chemistry with a minimum of 10 years of relevant experience; PhD is preferred.
  • Proficient in 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 advantageous.
  • Solid understanding of cGLP/cGMP and applicable FDA, EMA, and ICH guidelines.
  • Exceptional verbal and written communication skills.

Employee Benefits:

Pharmaron values its workforce and provides a comprehensive benefits package that allows employees to tailor their benefits to meet individual needs. Benefits include:

  • Medical, Dental & Vision Insurance with Employer Contribution
  • Health Reimbursement Account funded by the Employer
  • Flexible Spending Accounts for Healthcare & Dependent Care
  • 100% Employer Paid Life and AD&D Insurance
  • Voluntary Life and AD&D Insurance options for Employee, Spouse & Child(ren)
  • 100% Employer Paid Short and Long Term Disability Insurance
  • 401k Plan with Employer Matching
  • Employee Assistance Program