R&D Synthesis Manager

Company: ProStaff Solutions
Location: Chattanooga
Posted on: January 15, 2022

Job Description:

Direct Hire

Responsibilities:
Develop Robust, cost efficient and scalable chemical process for Active Pharmaceutical ingredients (APIs) that meets USP, FDA, and ICH quality guidelines.
Identify and synthesize process related impurities.
Take a lead and work with operation team in Plant during technology transfer.
Prepare SOPs, guidance and reports to support laboratory GMP function in compliance with FDA, ICH and other regulatory guidance.
Provide leadership, monitor scientists within group.
Communicate with direct report, management, team, internal and external customer about project and business-related matter.
Stay current with FDA/ICH regulation, analytical literature and analytical technology.
Participate in discussion on product strategies.
Maintain rigorous accountability and documentation of work related to controlled substance in accordance with established SOP and requirement of federal regulation.
Maintain highest standard of scientific professionalism.

Skills & Qualification:
PhD in Chemistry with minimum 3 years of experience in Pharmaceutical industry OR M.S. In Chemistry with minimum 10 years of experience in Pharmaceutical industry.
Demonstrated knowledge of Organic Synthesis, Process optimization, technology transfer, scale up, Process hazard study, troubleshooting and analytical data interpretation.
Highest level of skills handling hazardous, moisture and air sensitive chemicals,
Strong familiarization with GLP/ cGMP and FDA/ICH regulation.
Knowledge of Analytical Chemistry, Inorganic Chemistry and understanding of toxicology is required.
Strong ability to communicate experimental results to scientific and non-scientific members.
Capable to problem -solve.
Meticulous attention to details.
Excellent written and oral communication skills.
Possess strong time management skills.

Keywords: ProStaff Solutions, Chattanooga , R&D Synthesis Manager, Executive , Chattanooga, Tennessee