Analytical Science Group Lead – API Development

Eurofins; Massachusetts; On-site; USD 84,000 - 94,000; Full time

Benefits offered by this job

Medical coverage

Dental and vision options

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Job summary

Eurofins USA PSS Insourcing Solutions is seeking a Scientist Group Leader to oversee the development and validation of analytical methods for APIs in a GMP environment. The role focuses on chromatography, spectroscopy, and physical property testing, and requires leadership in a regulated pharmaceutical setting.

You will design, qualify, and transfer methods, supervise instrument maintenance, and support audit readiness with FDA and other agencies.

Qualifications

• BS in Analytical chemistry or equivalent with 5+ years related experience in analytical development (R&D and method qualification/validation) within pharmaceutical industry.
• MS in Analytical chemistry or equivalent with 3+ years related experience in analytical development (R&D and method qualification/validation) within pharmaceutical industry.
• PhD in Analytical chemistry or equivalent with related experience in analytical development (R&D and method qualification/validation) within pharmaceutical industry.

Responsibilities

• Lead the design, development, and execution of phase-appropriate analytical methods in compliance with ICH and Health Authority guidelines.
• Perform release and stability testing on starting materials, intermediates and API for both development and GMP samples.
• Author and review technical documents including method qualification/validation/transfer protocols and reports for analytical procedures.
• Maintain and troubleshoot analytical instrumentation.
• Contribute to audit readiness and participate in quality audits with FDA and other regulatory agencies and customers as needed.
• Ensure work complies with all state and federal regulations, including GMP, DEA, FDA, etc.

Job description

Eurofins USA PSS Insourcing Solutions is seeking a Scientist Group Leader to oversee the development and validation of analytical methods for APIs in a GMP environment. The role focuses on chromatography, spectroscopy, and physical property testing, and requires leadership in a regulated pharmaceutical setting.

You will design, qualify, and transfer methods, supervise instrument maintenance, and support audit readiness with FDA and other agencies.