Job Description

Job Summary:

We are seeking a highly skilled Analytical Scientist with a Ph.D. in Chemistry, Biochemistry, or a related scientific discipline and a strong background in the pharmaceutical, medical device, or biotechnology industry. The successful candidate will have proven expertise in GC-MS and extensive experience with extractables and leachables (E&L) analysis to support product development, regulatory submissions, and quality assurance.

Key Responsibilities:

• Lead and perform analytical testing with a focus on GC-MS for extractables and leachables (E&L) studies across a range of pharmaceutical or medical device products.
• Design, develop, validate, and execute analytical methods in compliance with ICH, USP, ISO, and FDA guidelines.
• Interpret complex analytical data, prepare technical reports, and present findings to cross-functional teams.
• Contribute to risk assessments and product qualification activities related to materials, packaging, and components.
• Maintain up-to-date knowledge of industry standards, emerging technologies, and regulatory expectations in E&L and GC-MS analysis.
• Ensure all laboratory work is conducted in compliance with GLP/GMP and safety requirements.

Required Qualifications:

• Ph.D. in Chemistry, Biochemistry, Pharmaceutical Sciences, or a closely related field.
• 1+ years of relevant industry experience in the pharmaceutical, biotech, or medical device sector.
• Expert-level proficiency in GC-MS, including method development, troubleshooting, and data interpretation.
• Demonstrated experience conducting and interpreting extractables and leachables studies.
• Strong technical writing and documentation skills for regulatory and quality submissions.
• Experience with other analytical techniques (e.g., LC-MS, ICP-MS, FTIR) is a plus.
• Experience working in a cross-functional, matrixed environment.

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