Principal Scientist - Extractables & Leachables

Headquartered in Nashville, TN – one of the fastest-growing and most exciting cities in the United States – August Bioservices is a privately-owned, high-growth, and high-impact Contract Development Manufacturing Organization (CDMO) and Contract Research Organization (CRO).  As a US-based outsourcing partner that provides a wide array of expert drug discovery, drug formulation, and drug manufacturing services to pharma and biotech companies of all sizes, we play a vital role in the global pharmaceutical industry. Our work is instrumental in helping to develop molecules today that can become the life-changing therapies of tomorrow. To support our growth plans, August is investing significant capital in a two-phase expansion project – including building a new state-of-the-art facility adjacent to our current facility. For those seeking dynamic opportunities, rewarding career paths and a chance to make a difference in global health, come grow with August!

Reporting to the Director, Quality Control, 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.  August Bioservices seeks an adaptable, disciplined, and dependable individual with extensive knowledge and experience.  

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 Requirements

• 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

August Bioservices  is an equal opportunity employer and values diversity. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. August Bioservices does not discriminate on the basis of any status protected under federal, state, or local law.