Scientist I/II

Reporting to the Senior Manager of Analytical Development (AD), Scientists I/II, are responsible for performing routine analytical testing and laboratory activities using approved methods and protocols under the supervision of Senior or Principal Scientist. The ideal candidates will have support method development, validation, and testing for assay and impurity analysis requirements to satisfy regulatory requirement for new drug applications. August Bioservices seeks to hire two adaptable, disciplined, and dependable individuals with analytical development and validation experience.

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.