Senior Specialist, Research Medical Device Combination Products - Onsite

Job Description

The Analytical Research and Development group has an opening for a Senior Specialist based in Rahway, NJ. Join us and experience our culture first-hand - one of strong ethics & integrity, diversified experiences, exceptional science, and a resounding passion for improving human health through innovative drug delivery technologies and predictive analytical tools. As part of our global team, you will have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. --

In your role as Senior Specialist, you will be part of a cross-functional team in charge of testing, managing, coordinating, and facilitating analytical support to enable medical device and combination product development and commercialization.- -We are seeking a hands-on, lab-based specialist to support GMP testing of devices (components, sub-assemblies, and full devices) and combination products (drug-delivery products) including method validation and transfer activities. The role will utilize a wide variety of cutting-edge analytical instruments in collaboration with device development teams to build robust and consistent methods for clinical and commercial product release and stability testing.

Primary Responsibilities

• Responsible for validating and performing test procedures for clinical supply release and stability testing according to specifications for medical device components and combination products.
• Responsible for performing validation activities to support commercial method validation and transfer activities in collaboration with Device Development & Technology, Development Quality, and Strategy Leads.
• Support, manage, and coordinate analytical support for medical device release testing in a timely manner following GMP procedures.
• Document the execution, procedure, results, and conclusions of experiments in a detailed manner in compliance with Standard Operating Procedures (SOPs) and Attributable, Legible, Contemporaneous, Original and Accurate (ALCOA) principles.
• Author technical reports, analysis certificates, investigations/deviation records, and SOPs.-------
• Perform data entry, data review/approval, and author analytical reports or data summaries.
• Troubleshoot and lead any investigations associated with GMP testing through active collaboration with Device Development & Technology, Development Quality. Identify appropriate corrective and preventative actions.
• Directly contributes to experimental design, execution, and data interpretation for validation studies.
• Support internal and external compliance audit activities.

Education Minimum Requirements:

• A PhD degree or 4 years of experience with a MS degree, or 7 years of experience with a BS in Science or Engineering.

Required Experience and Skills

• A proven record of cross-functional collaboration, operational excellence, and strong technical problem solving. Excellent written and oral communication skills, as well as interpersonal skills, are necessary to qualify for this role.

Preferred Experience and Skills

• Though not required, the ideal applicant would have hands-on experience in GMP operations, package component or medical device release testing, validation experience including engineering studies, design verification protocols, stability studies and validation protocols.-
• Familiarity with ISO standards, FDA, and MDR regulations involving medical device requirements and experience leading cross-functional teams is a plus.

Required Skills:
Accountability, Adaptability, Analytical Chemistry, Clinical Data Interpretation, Combination Products, Data Analysis, Documentation Review, Experimentation, GMP Compliance, Lab Equipment Maintenance, Laboratory Management, Method Validation, Personal Initiative, Project Reviews, Raw Material Testing, Regulatory Compliance, Scientific Research, Specification Documents, Strategic Planning, Teamwork, Technical Writing, U.S. Pharmacopeia (USP)

Preferred Skills:
Statistical Analysis

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:

EEOC Know Your Rights

EEOC GINA Supplement•

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

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

The salary range for this role is
$106,200.00 - $167,200.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this 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 .

You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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:
Domestic

VISA Sponsorship:
No

Travel Requirements:
No Travel Required

Flexible Work Arrangements:
Not Applicable

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
Yes

Job Posting End Date:
04/28/2026
*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: R390088