Principal Scientist - Analytical Development

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).  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 head of Quality Control, the Principal Scientist is responsible for the operational and functional leadership of the Analytical Development laboratory. The ideal candidate will have small molecule method development, validation and testing experience to support clinical and commercial manufacturing. August Bioservices seeks an adaptable, disciplined, and dependable individual with extensive analytical development and validation experience.  

Responsibilities

• Identifies, evaluates, develops, and validates analytical methods for compendial, raw material, drug substance and finished product testing 
• Provides subject matter expertise in common analytical chemistry techniques (HPLC/UPLC, LC-MS, GC etc.)  
• Leads laboratory investigations for OOT and OOS results  
• 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  
• Analyzes complex data sets, interprets and integrates experimental results with project objectives  
• 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  
• Drives new technology assessment and procurement/onboarding in analytical instrumentation, formulation equipment and techniques, devices, and methods  
• Handles multiple tasks and meets timelines while quickly adapting to changing priorities  
• Authors and executes developmental protocols and summary reports  
• Reviews and approves data from analytical experiments   

Requirements

• Ph.D. in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Bioengineering or related field with 12+ 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 guidelines  
• Outstanding Good Documentation Practices (GDP)   
• Passion for 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 software
• Previous CDMO experience
• Previous line management experience
• Process Validation and Commercialization requirements for finished products
• Experience with lyophilized products and pre-filled syringes
• NDA/CMC filing experience

At August Bioservices, Our Credo is our culture. Everything we do, we do with great care. We believe in the promise of discovery and the power of science to transform lives. We assert that excellence is not a static destination, but a standard, and an every-day measuring stick of our advancement. We aspire to unlock the potential in every person, every process and every molecule – from start to finish. We are committed to doing the right thing the first time and every time, meeting or exceeding all regulatory requirements. We strive to be exceptional, preferred and indispensable partners for our customers; responsible and engaged citizens within our