Are you an experienced analytical scientist looking to drive small molecule development? A top-tier global biopharmaceutical leader in Bridgewater, NJ is seeking a Contractor, Analytical Development for a dynamic 12-month on-site role. This position uniquely balances 70% hands-on laboratory method development with 30% external vendor oversight.
location: Bridgewater, New Jersey
job type: Contract
salary: $65 - 70 per hour
work hours: 9 to 5
education: Doctorate
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.
qualifications:
Required:
- 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.
- Experience authoring eCTD sections for global regulatory submissions.
skills: Vendor Management, Assay Method, High Pressure Liquid Chromatography (HPLC)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
