Analytical Development Manager – Ballwin, MO *Relocation Provided

Direct Hire
Shift: M-F 8a-5p
Salary: 150K-180K

Responsibilities

• Represent analytical function in cross-functional teams and define work scope that are aligned with project objectives and team needs.
• Design studies, generate and analyze data, interpret experimental results, prepare study reports, and present summaries to project teams and management.
• Possess strong problem-solving skills with attention to details and the ability to troubleshoot.
• Develop, validate, and transfer analytical methods for raw materials, in-process materials, finished products, and stability samples.
• Independently perform hands on bench work and apply expertise to a wide range of assignments, such as performing complex HPLC/UPLC method development, identifying impurities with MS, developing in vitro release testing and other analytical methods as needed.
• Prepare and review regulatory submission documents, support regulatory deficiency responses.
• Follow pharmaceutical cGMP and GDP practices.
• Guide and mentor junior scientists.
• Assist in maintaining laboratory instruments and facilities.
• Adhere to all health, safety, and environmental requirements.
• Extended work hours may be occasionally required based on project needs.
• Ability to travel domestically and internationally up to 15% of the time.
• Additional duties and assignments as needed.

Required Qualifications

• Ph.D. in analytical chemistry or related disciplines, with at least 8-10 years of relevant experience in a pharmaceutical analytical R&D environment. M.S. in chemistry with at least 15 years of relevant experience. Combinations of education and experience with complex formulation is a plus.
• Demonstrated track record in leading analytical development activities and project management skills including project initiation, planning and execution.
• Strong problem-solving skills with deep understanding of pharmaceutical development process.
• Strong hands-on experience with HPLC/UPLC, GC, mass spectroscopy, dissolution and other advanced techniques for analysis of complex products.
• Good knowledge of common physicochemical characterization techniques used in pharmaceutical development, such as particle size, viscosity, TGA/DSC for evaluation of complex formulation.
• Familiar with USP/NF, EP and JP compendial methods and verification requirements.
• Updated knowledge of FDA, ICH Guidelines and other related regulatory requirements.
• Experience and knowledge of cGMP required, experience with DEA requirements preferred. 10.

For Immediate Consideration, Apply Today! For more information contact Toni at 714 454 8252 / TONM369@kellyservices.com, or schedule a time to connect @ https://calendly.com/tonm369/interview

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You should know: Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

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