Contractor, Analytical Development

Contract role in Bridgewater, NJ for 12 months, blending 70% hands-on lab work with 30% vendor oversight.

Responsibilities

• Conduct routine and complex analytical testing, method development, and optimization using HPLC, UHPLC, GC, and dissolution instrumentation.
• Provide scientific oversight for CRO/CMO relationships to ensure seamless method transfer and analytical execution.
• Author and review CMC technical sections for regulatory submissions (INDs, NDAs), as well as SOPs and validation protocols.
• Partner cross-functionally with Chemical Process and Formulation Development teams to support Active Pharmaceutical Ingredients (API) and Drug Product (DP).
• Maintain detailed, compliant laboratory notebooks and communicate data effectively to project leads.

Requirements

• PhD in Chemistry, Biochemistry, or related discipline with 6+ years of biotech/pharma experience, or MS with 8+ years of relevant experience.
• Strong hands-on laboratory expertise with HPLC, UHPLC, UV, pH, moisture content, and dissolution testing.
• Proven experience managing and overseeing external CRO/CMO partnerships.
• Background authoring or contributing supporting data to CMC regulatory filings.

Preferred Qualifications

• Experience authoring eCTD sections for global regulatory submissions.

Skills

• Vendor Management
• Assay Method
• High Pressure Liquid Chromatography (HPLC)

Pay

$65 - 70 per hour

Schedule

9 to 5, on-site for 12 months

Benefits

• Medical, prescription, dental, and vision insurance
• AD&D and life insurance
• Short-term disability
• 401K plan