Extractables & Leachables Specialist
Merck
Summary
As an Extractables & Leachables Specialist, you will be responsible for performing risk assessments and evaluations related to extractables and leachables for both commercial products and development projects. You will apply established scientific frameworks, procedures, and policies to assess risks, coordinate testing programs, and interpret results, working closely with stakeholders across Packaging, Quality, Regulatory Affairs, Manufacturing, and R&D.
Job description
About the Role
As an Extractables & Leachables Specialist, you will be responsible for performing risk assessments and evaluations related to extractables and leachables for both commercial products and development projects. You will apply established scientific frameworks, procedures, and policies to assess risks, coordinate testing programs, and interpret results, working closely with stakeholders across Packaging, Quality, Regulatory Affairs, Manufacturing, and R&D.
Key Responsibilities
- Conduct extractables and leachables risk assessments for packaging materials, process contact materials, and devices.
- Coordinate E&L testing programs and interpret results within established project frameworks.
- Prepare, review, and maintain technical reports and documentation.
- Provide E&L expertise in support of commercial product portfolios and R&D projects.
- Contribute to validation and qualification activities related to changes in packaging, labels, devices, and process contact materials.
- Support investigations into quality issues and identify appropriate corrective actions.
- Prepare E&L documentation for audits, inspections, and regulatory submissions.
- Identify risks, communicate progress, and contribute to successful project outcomes.
- Share knowledge and contribute to the further development of E&L methodologies, tools, and ways of working.
- Actively contribute to compliance, quality, safety, and continuous improvement across the organization.
Minimum Requirements
- Bachelor's or Master's degree in a relevant scientific or technical discipline, such as Chemistry, Pharmaceutical Sciences, Biotechnology, or a related field.
- Knowledge of extractables and leachables risk assessments or similar analytical and pharmaceutical challenges.
- Experience within a regulated environment, such as pharmaceuticals, medical devices, or life sciences.
- Strong analytical skills and scientific problem-solving capabilities.
- Experience preparing and reviewing technical documentation and reports.
- Ability to work independently within established procedures and quality frameworks.
- Strong communication skills and the ability to collaborate effectively with international stakeholders.
- Excellent command of the English language, both written and spoken.
Requirements
- Bachelor's or Master's degree in a relevant scientific or technical discipline such as Chemistry, Pharmaceutical Sciences, Biotechnology, or related field
- Knowledge of extractables and leachables risk assessments or similar analytical and pharmaceutical challenges
- Experience within a regulated environment such as pharmaceuticals, medical devices, or life sciences
- Strong analytical skills and scientific problem-solving capabilities
- Experience preparing and reviewing technical documentation and reports
- Ability to work independently within established procedures and quality frameworks
- Strong communication skills and ability to collaborate with international stakeholders
- Excellent command of the English language, both written and spoken
Benefits
- Medical, Dental & Vision
- Retirement Benefits
- 401(k)
- Paid Holidays
- Vacation
- Sick Days
- Annual Bonus
- Long-Term Incentive
Company overview
Merck & Co., Inc., known as Merck in the United States and Canada and MSD (Merck Sharp & Dohme) internationally, is a premier American multinational pharmaceutical company headquartered in Rahway, New Jersey. Founded in 1891 as the U.S. subsidiary of the German Merck Group, the company became independent following World War I and has since grown into one of the world's largest biomedical companies, ranking fourth globally by revenue. Merck operates across three core business segments: pharmaceuticals, vaccines, and animal health products. The company is renowned for its groundbreaking research and development, having brought numerous life-saving medicines to market including Keytruda (pembrolizumab), a leading immunotherapy for cancer treatment that generated $29.5 billion in 2024 revenue, and Gardasil, a revolutionary HPV vaccine. With approximately 75,000 employees worldwide, Merck maintains a robust pipeline of innovative therapies focused on oncology, vaccines, hospital acute care, cardiology, neuroscience, virology, immunology, and diabetes. The company invests heavily in R&D, spending $17.9 billion in 2024 alone, demonstrating its commitment to advancing scientific discovery. Merck's legacy spans over 130 years of bringing hope to humanity through important medicines and vaccines, operating with a purpose to use leading-edge science to save and improve lives globally while fostering an inclusive workforce and responsible business practices.