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30 days old

Principal Scientist - Extractables & Leachables (E&L)

Kelly Services
Nashville, TN 37230
**Principal Scientist, Extractables and Leachables (E&L)**


Kelly Science & Clinical is looking for a Principal Scientist, Extractables and Leachables in the Nashville, TN area. This is a direct hire, permanent position with a privately owned Contract Development Manufacturing Organization (CDMO) and Contract Research Organization (CRO) in the global pharmaceutical industry.


The Principal Scientist, Extractables and Leachables (E&L) is responsible for the operational and functional leadership of the E&L laboratory. The ideal candidate will have extensive experience designing and executing E&L studies. This position is primarily focused on parenteral solution, suspension, and semi-solid formulations. However, the position also may support examination of drug metabolic pathways, structure elucidation, and data interpretation from a pharmacokinetics and pharmacodynamics perspective as a secondary function.


**Responsibilities**


+ Identifies, evaluates, develops, and validates analytical methods for extractable and leachable components from pharmaceutical packaging or devices

+ Sample preparation and operation of MS instrumentation, interpretation, analysis, documentation and reporting of results, integrating experimental data and results with project objectives

+ Utilizing the latest state of the art MS capabilities/techniques, analytical software and databases to identify and quantify chemical species e.g. leachables, extractables, degradation/reaction products, additives, etc.

+ Subject matter expert (SME) in common analytical chemistry techniques for E&L (HPLC/UPLC, LC-MS, GC-MS etc.)

+ Leads experimental design, data evaluation, data trending, scientific writing and coordination of studies

+ Collaborates with project teams and customers to meet project objectives, budgets and timelines

+ Performs safety inspections, general lab housekeeping, cleaning/sterilizing of lab and lab materials and ordering/maintaining supplies

+ Leads, coaches and mentors direct reports along with other team members

+ Develops and maintains a comprehensive understanding of regulatory guidance pertaining to all aspects of drug product development


**Requirements**


+ Ph.D. in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Bioengineering or related field with 10+ years of relevant pharmaceutical industry experience OR MS with over 15+ years of relevant experience

+ Expertise in a GMP manufacturing environment

+ Theoretical and practical knowledge of method development and validation principles to ICH and other applicable guidelines

+ Outstanding Good Documentation Practices (GDP)

+ Strong background in HPLC/UPLC, LC-MS, GC-MS, E&L testing and structure elucidation

+ Passion for rigorous science with a strong motivation for Continuous Improvement

+ Exceptional communication and interpersonal skills, ability to work in a dynamic, time-sensitive environment and prioritize work as assigned

+ Highly motivated and self-directed, detail-oriented and schedule-driven

+ Strong analytical and problem-solving skills

+ Able to work flexible schedules to complete assigned tasks


**Preferred**


+ Experience applying QbD principles to analytical method development and optimization, process, and product development

+ Familiarity and working knowledge with design aspects of DoE and UNIFI software

+ Previous CDMO experience

+ Previous line management experience

+ Experience with lyophilized products and pre-filled syringes

+ NDA/CMC filing experience

+ Experience with intact protein analysis and protein fragmentation methods is an added benefit

+ Knowledge around tissue preparation and sample extraction is an added benefit

+ Familiarity with drug metabolic pathways, structure elucidation, and interpreting data from a pharmacokinetics and pharmacodynamics perspective is an added benefit


**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.


**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 interestsits 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, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were 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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2022-04-18 Expires: 2022-06-18

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Principal Scientist - Extractables & Leachables (E&L)

Kelly Services
Nashville, TN 37230

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