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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in chemical and physical analyses, analytical method development, and compliance within a cGMP regulated environment. Proficient in operating advanced analytical instrumentation and effectively organizing workflows to support product development and quality assurance.
Highest-signal resume keywords
Chromatography Skills Using EmpowerAnalytical Method DevelopmentExperience in cGMP Regulated EnvironmentProficiency in Microsoft OfficeExperience with MDI/DPI Analytical Test Methods
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Chemical AnalysisPhysical AnalysisData AnalysisAnalytical Method ValidationStandard Operating ProceduresStatistical AnalysisInstrument CalibrationQuality InvestigationsDocumentation CompilationProblem-Solving
Soft Skills
Organizational SkillsGuidance and SupportEffective Communication
Tools & Technologies
HPLCUPLCGCUV-VisFTIRLaser DiffractionKFEmpower
Industry Keywords
CGMPRegulatory ComplianceProduct DevelopmentStability TestingAnalytical Testing
About the role
Key responsibilities & impact- Perform chemical and physical analyses of raw materials, in-process materials, and drug products following standard operating procedures.
- Support product development, release, and stability testing.
- Operate analytical instrumentation such as HPLC, UPLC, GC, UV-vis, FTIR, laser diffraction, and KF.
- Statistically and critically analyze data for trending and reporting into regulatory filings.
- Participate in laboratory and/or quality investigations.
- Monitor equipment and instrumentation daily to ensure proper operation and calibration.
- Participate in the construction and/or revision of standard operating procedures.
- Assist in writing and updating analytical test procedures, protocols, log books, and checklists.
- Identify, alert, and propose solutions to issues on instruments and/or test executions.
- Lead and implement recommended solutions and/or corrective actions.
- Independently organize workflows to accomplish objectives.
- Provide guidance and support to colleagues and promote new policies and programs effectively.
- Compile data for documentation, participate in investigations and reports, and ensure compliance with specifications.
Requirements
What you’ll need- Bachelor’s Degree is required, preferably in Physical or Chemical Sciences (life sciences).
- Minimum of 4–6 years of experience in a cGMP regulated environment is required.
- Chromatography skills using Empower is required.
- Proficiency in Microsoft Office is required.
- Ability to lift up to 20 lbs. is required.
- Ability to stand for long periods of time is required.
- Experience in MDI/DPI analytical test methods such as Andersen Cascade Impactor and Emitted Dose techniques is preferred.
- Experience with analytical method development and validation is preferred.
Benefits
Comp & perks- Defined career path and annual performance review and feedback process.
- Diverse, inclusive culture.
- Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
- Competitive paid time off plus 8 paid holidays.
- Community engagement and green initiatives.
- Medical, dental, and vision benefits effective day one of employment.
- Tuition reimbursement.
- Bonus eligibility.
