Summary
The Analytical Chemist III independently performs routine and non-routine analysis on raw materials, drug substances, reference materials and drug products using a variety of instrumental and wet chemistry techniques. The Analytical Chemist III will also intermittently serve as a dedicated project leader and subject matter expert for analytical testing requirements for drug development and regulatory submissions. In addition, the Analytical Chemist III maintains the laboratory and all documentation within cGMP guidelines.
Essential Duties and Responsibilities
Ø Perform routine and non-routine analysis on raw materials, drug substances, reference material and drug products using a variety of instrumental and wet chemistry techniques.
Ø Independently design and execute method development and validation activities for pharmaceutical drug product development on a limited basis.
Ø Author protocols and reports as needed.
Ø Serve as a dedicated project leader and subject matter expert for analytical testing requirements for drug development and regulatory submissions on a limited basis.
Ø Mentor and guide junior chemists on a limited basis.
Ø Attend client project meetings related to analytical testing timelines on a moderate basis.
Ø Conduct laboratory testing in accordance with methods, protocols, SOPs and cGMP guidelines.
Ø Assist in maintaining an organized laboratory.
Ø Preparing and reviewing documentation such as laboratory notebooks, validation and analysis reports, SOPs, methods and monographs.
Ø Develop systems that are cost effective and increase efficiency.
Ø Interface with all departments as necessary.
Ø Adhere to set safety standards.
Ø Participate as a team member, support the company mission, and vision and contribute to the pursuit of the company's goals.
Ø Participate actively in regular meetings.
Ø Achieve expected performance measures.
Ø Other duties as assigned.
Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
Ø BS or BA degree in Chemistry or a related physical science with 5+ years of analytical drug development in a pharmaceutical laboratory preferred.
Ø Master's degree in Chemistry or a related physical science with 2 years of analytical drug development in a pharmaceutical laboratory preferred.
Ø PhD in Chemistry or a related physical science with at least of 1 experience in analytical drug development in a pharmaceutical laboratory preferred.
Ø Experience in HPLC analysis, dissolution, and
moisture determination techniques strongly preferred.
Ø Excellent oral and written communication skill to communicate with the team, peers, management, and external contacts.
Ø Experience with interpreting and implementing cGMPs, ICH, FDA, DEA and OSHA guidelines.
Ø Must have the ability to work effectively and independently.
Ø Working knowledge of personal computers and Microsoft Office Products, including Word, Project, and Excel
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