Extractables & Leachables Specialist

Job Description

Welcome to Our Team

Within our Global Packaging Technology & Support organization, the Extractables & Leachables (E&L) Center of Excellence plays an important role in supporting the global Animal Health organization. As part of this expert group, we assess risks associated with packaging materials, process contact materials, and medical devices used in our pharmaceutical products.

You will join an international environment where you collaborate with colleagues from Packaging, Quality, Regulatory Affairs, R&D, Manufacturing, and external laboratories. Together, you ensure that our products meet the highest quality and safety standards and comply with global regulations.

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. In doing so, you will work closely with stakeholders across Packaging, Quality, Regulatory Affairs, Manufacturing, and R&D.

In this role, you will combine scientific expertise with project-based work and make a direct contribution to product safety, compliance, and continuous improvement.

Animal Health

Our Animal Health division is a trusted global leader in veterinary medicine, dedicated to preserving and improving the health, well-being, and performance of animals and the people who care for them. We are a global team of professionals working together to make a positive impact on animal care and the world’s food supply, with a strong sense of responsibility toward our customers, consumers, animals, society, and the planet.

Through our commitment to The Science of Healthier Animals® , we provide veterinarians, farmers, pet owners, and governments with one of the broadest portfolios of veterinary pharmaceuticals, vaccines, and health management solutions and services. This includes an extensive range of digitally connected identification, traceability, and monitoring products. We invest in dynamic and comprehensive R&D capabilities and a modern global supply chain. We operate in more than 50 countries, with our products available in approximately 150 markets worldwide.

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.

Required Skills:

Biotechnology, Biotechnology, Calibration of Equipment, Chemistry, Computerized Maintenance Management Systems (CMMS), Continuous Improvement Techniques, Corrective Action Management, Data Analysis, Engineering Document Management, Equipment Maintenance, Failure Mode and Effects Analysis FMEA, Manufacturing Quality Control, Medical Devices, Meditation Techniques, Packaging Supplies, Pharmaceutical Products, Pharmaceutical Sciences, Preventive Maintenance, Process Improvements, Process Instrumentation, Production Scheduling, Product Security, Product Support, Regulatory Affairs Management, Regulatory Submissions {+ 7 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

The primary location for this posting is:

USA - New Jersey - Rahway

Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is:

$87,300.00 - $137,400.00

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits .

Additional location(s): Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

Additional location(s) Compensation Information:

San Francisco Residents Only:  We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:  We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully 

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

Yes

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

11/18/2026 *A job posting is effective until 11:59:59PM on the day BEFORE  the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R427095