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 <1225>, 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.

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 communities; and active, mindful stewards of our environment.
 
We are August Bioservices. We are pointing the way forward. If this sounds like your kind of working environment, we want you on our team!

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.