QC / R&D Analytical Chemist

QC / R&D Analytical Chemist (Sterile Injectables & Complex Generics)

Job Description: Element Staffing is recruiting for a mid-level QC / R&D Analytical Chemist for a fast-growing Contract Development and Manufacturing Organization (CDMO) specializing in sterile injectables and complex generic drug development located in San Diego, CA. This position is ideal for an experienced chemist looking to work at the intersection of Quality Control and Research & Development. The successful candidate will play a key role in executing routine and non-routine analytical testing, supporting stability study programs, assisting with analytical method development and transfer, and conducting internal developmental studies for pipeline drug products.

Duties/Responsibilities/Qualifications:

• Stability & QC Testing: Execute qualitative and quantitative testing of raw materials, in-process samples, finished drug products, and shelf-life stability samples in accordance with ICH guidelines.

• Method Development & Transfer Support: Assist R&D teams in analytical method development, verification, validation, and transfer for complex drug formulations.

• Internal & R&D Studies: Conduct characterization studies, forced degradation testing, and feasibility studies to support internal product development pipelines.

• Instrumentation & Analysis: Independently operate, troubleshoot, and maintain analytical laboratory equipment, including HPLC, UPLC, GC, UV-Vis, Karl Fischer titrators, and dissolution systems.

• Data Documentation & Review: Prepare detailed technical reports, analytical data packets, Certificates of Analysis (CoA), and stability summary data sheets following cGMP and data integrity guidelines.

• Investigations & Compliance: Participate in Out-of-Specification (OOS), Out-of-Trend (OOT), and laboratory deviation investigations alongside QA and senior team members.

• Standard Operating Procedures: Draft and update SOPs, analytical testing procedures (ATPs), and validation protocols.

• Cross-Functional Collaboration: Coordinate with cross-functional teams, including Formulations, Regulatory Affairs, and Quality Assurance, to ensure project deadlines are met.

Additional Information:

• Years of Experience: 3–5 years of hands-on analytical chemistry experience in an FDA-regulated cGMP pharmaceutical laboratory or CDMO/CRO environment. (Mid-level role).

• Education: Bachelor’s (B.S.) or Master’s (M.S.) degree in Chemistry, Biochemistry, Analytical Chemistry, or a related scientific discipline.

• Shift/Schedule: Standard daytime hours (Monday – Friday). Minimal travel required.

• Requirements: Proven hands-on proficiency with HPLC / UPLC (Waters Empower or Agilent ChemStation preferred) and GC systems. Strong working familiarity with ICH guidelines (specifically ICH Q1A/Q1B for stability testing and ICH Q2 for method validation). Solid understanding of cGMP, GLP, and USP compendial testing standards. Strong technical writing, problem-solving, and analytical troubleshooting skills.

• Compensation: $36.00 – $45.00/hr ($75,000 – $95,000 annualized equivalent) DOE

• Location: San Diego, CA

For immediate consideration, please send your resume to resumes.westcoast@element-staffing.com.

Keyword Cloud

Skill Areas:

Analytical Chemistry, QC Chemist, R&D Chemist, HPLC, UPLC, Gas Chromatography, GC, Waters Empower, Agilent ChemStation, UV-Vis Spectroscopy, Karl Fischer, Dissolution Testing, Method Development, Method Validation, Method Transfer, ICH Guidelines, Forced Degradation, Stability Studies, OOS Investigations, OOT, Laboratory Deviations, Certificates of Analysis, CoA, USP Compendial Testing, cGMP, GLP, Data Integrity, Technical Writing.

Industry:

Pharmaceutical Manufacturing, CDMO, CRO, Sterile Injectables, Complex Generics, Drug Development, Analytical Services, Quality Control, Life Sciences Staffing.

Geography:

San Diego, La Jolla, Sorrento Valley, Torrey Pines, Carlsbad, Oceanside, San Diego County, SoCal, Southern California, On-site.