Scientist Group Leader

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 Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

The Scientist Group Leader is responsible for the development and implementation of analytical procedures and specifications in support of the development and manufacture of active pharmaceutical ingredients (APIs) for traditional synthetic molecules (including potent) and peptides. Primary analytical techniques include chromatography (HPLC/UPLC, GC, and IC), Spectroscopy (LC-MS, GC-MS, NMR, ICP-MS, FTIR and UV-Vis), and physical properties (particle size, water content, etc.). Core 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 forboth 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.
• Responsible for contributing to audit readiness and for participating in quality audits with FDA, other Regulatory Agencies, and customers, as needed.
• Ensures work in compliance with all state and federal regulations, including but not limited to GMP, DEA, FDA, etc.

• BS in Analytical chemistry or equivalent with 5+ years related experience in analytical development (R&D and method qualification/validation) environment within pharmaceutical industry.
• MS in Analytical chemistry or equivalent with 3+ years related experience in analytical development (R&D and method qualification/validation) environment within pharmaceutical industry.
• PhD in Analytical chemistry or equivalent with related experience in analytical development (R&D and method qualification/validation) environment within pharmaceutical industry.
• Experience with common analytical techniques such as: HPLC/UPLC, GC, NMR, UV, KF, FTIR, XRPD, LC-MS, GC-MS and ICP-MS.
• Minimum of 5 years’ experience in method development and validation for small molecules Active Pharmaceutical Ingredients (APIs). Experience with Process Development of APIs.
• Previous leadership experience preferred

The position is full-time, Monday-Friday, 8:00am-5:00pm, with overtime as needed.

• Compensation: $84,000-94,000
• Excellent full time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.