Scientist I/II

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 requirements.
• Demonstrates ownership of assigned projects and assists 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.