Senior Analytical Scientist

Pharmaron Manufacturing Services has a position for a Sr. Analytical Scientist at its Coventry, Rhode Island facility.

This position will support manufacturing activities through analytical method development, optimization, validation, and transfer in compliance with all applicable guidelines.

Key Responsibilities Include:

• Perform all assigned tasks in a timely and organized manner in accordance with cGMP, GLP, and company policies and procedures.
• Ensure high quality in analytical work and accurately document all necessary and relevant information in a clear concise manner as per cGMPs.
• Develop / improve and/or validate robust analytical methods that are GMP friendly based on quality-by-design and document formal protocols and reports.
• Participate in method transfer activities, including writing protocols and reports.
• Perform stability testing and data trending, as required.
• Review experimental data, notebooks, and instrument qualification protocols / reports.
• Actively participate in investigations, problem solving, and troubleshooting. Write investigation reports.
• Prepare and present data summaries (written and oral) as necessary. Present to cross functional teams and effectively communicate critical analytical issues and solutions.
• Write, revise, develop, and evaluate SOPs.
• Operate and maintain all analytical instrumentation and equipment as per established procedures.
• Communicate openly within the group to provide and gather information, to optimize the use of resources, and to optimize efficiency.
• Provide training and assistance to other group members.
• Support identification and qualification of API related impurities and degradants.
• Maintain good laboratory practices in compliance with safety and environmental requirements.
• Ability to work successfully in both a team/matrix environment as well as independently.
• Performs other related assignments and duties as required and assigned.

• Proven skills in analytical method development and validation of small molecules
• Proven scientific skill and ability to perform complex scientific work independently with no guidance
• Effective in managing multiple competing activities and delivering to timelines
• Ability to work in a cross-function environment
• High level of awareness to innovative technologies and ability to adapt to in-house needs.

Education and Experience:

• MS in Analytical Chemistry with 10 years of experience, PhD preferred
• Experience in HPLC, GC, FTIR, UV, LC/MS, and wet chemistry
• Experience with NMR, ICP-MS, XRPD, DSC-TGA, LC/MS and/or GC/MS preferred
• Working knowledge of cGLP/cGMP and applicable FDA, EMA and ICH guidance
• Excellent communication skills, both verbal and written

Benefits:

Pharmaron cares about our work community and offers a variety of benefits allowing employees the opportunity to customize a benefits package that meets their personal needs. Company benefits include the following:

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