Scientist I/II

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! ESSENTIAL DUTIES & RESPONSIBILITIES · Independently performs analytical testing and supports analytical development activities using established scientific principles. · Contribute to method development, qualification, validation, transfer, and characterization studies for small molecules and large molecules with minimal supervision. · Perform laboratory investigations for OOT and OOS results. · Independently plans and prioritizes daily laboratory activities to meet project timelines. · Manages multiple assignments simultaneously, identifies scheduling conflicts, and communicates risks proactively while requiring minimal supervision. · Independently troubleshoots routine analytical methods, instrumentation, and laboratory issues. · Investigates unexpected results using scientific rationale, recommends corrective actions, and escalates complex technical issues when appropriate. · Clearly communicates scientific findings through technical reports, presentations, and routine project updates. · Document analytical activities accurately and effectively communicate technical challenges and recommendations to project teams and management. · Collaborate effectively with Analytical Development, Quality Control, Quality Assurance, Manufacturing, MS&T, and Project Management teams. · Consistently deliver high-quality analytical work that meets project timelines while maintaining compliance with cGMP requirement. · Demonstrates ownership of assigned projects and assist with onboarding, laboratory training, and sharing technical knowledge. Promote continuous improvement within the laboratory. · Independently operate HPLC/UPLC systems using Waters Empower software. · Independently execute method qualification, validation, transfer, and routine LC-MS, GC-MS/FID, and ICP-MS analyses. · Interpret chromatographic and mass spectrometry data using sound scientific judgment. · Support stability studies forced degradation studies, impurity analysis, extractables/leachables (where applicable), and product characterization activities. · Author and review technical documents including protocols, SOP revisions, and test methods. · Use Master Control, LIMS, and project tracking tools independently. · Performs safety inspections, general lab housekeeping, and cleaning/sterilizing of lab and lab materials. · Understand the complete analytical testing workflow from method development through validated release testing. · Participate in client-facing project meetings as a technical contributor. · Consistently apply ALCOA+ principles across all analytical data. · Maintain working knowledge of ICH Q2(R2), USP , and applicable guidelines for method validation. · Handle multiple tasks and meet timelines while quickly adapting to changing priorities. KNOWLEDGE, SKILLS, & ABILITIES · 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 QUALIFICATIONS BS in Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related scientific discipline with 2+ years of relevant experience; MS with 2+ years of relevant experience preferred or PhD in Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related scientific discipline. Experience in a cGMP pharmaceutical or CDMO analytical laboratory is required; OR equivalent combination of education and experience.