Principal analytical development scientist

---

Job description

**Kelly Services is seeking a Principal Scientist for a Direct Hire role in St. Louis, MO.**

Our client is a Ballwin, MO-based pharmaceutical research and development company which focuses on research and development of novel therapeutics for unmet medical needs. The laboratory is currently seeking a highly motivated **Principal analytical development scientist** with proven track record in pharmaceutical development. This role will be leading analytical development activities on multiple projects. **The major responsibilities include analytical method development, transfer, and validation.** The selected candidate will work in multidisciplinary teams and with CRO/CMOs in support of drug product development, manufacturing, and regulatory filing.

**Job Responsibilities**

• 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, conducting method transfer and validation.

• Represent analytical function in cross-functional teams. Define 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.

• 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 time.

• Additional duties and assignments as needed.

**Required Qualifications and Skills:**

• Ph.D. in analytical chemistry or related disciplines, with at least 3 years of relevant

experience in a pharmaceutical analytical R&D environment. M.S. in chemistry

with at least 6 years of relevant experience. Strong candidates with combinations

of education and experience will be considered.

• Strong hands-on experience with HPLC/UPLC, GC, mass spectroscopy,

dissolution testing.

• Good knowledge of other common physicochemical characterization techniques

used in pharmaceutical development, such as particle size, TGA/DSC.

• 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.

• Demonstrate ability to work as part of a cross-functional team.

• Ability to communicate in an open, clear, timely and consistent manner.

• Strong problem solver who is highly organized with the ability to thrive and to lead

in an environment with rapidly changing priorities.

**APPLY NOW!**

**For immediate consideration, please send your resume in a WORD document to **

\#TJP2021_SPEC

**Why Kelly** **®** **?**

Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

**About Kelly** **®**

At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. ()