Sr. Specialist, Research (Onsite)

Job Description

Senior Specialist, Small Molecule Analytical Research & Development

Small Molecule Analytical Research and Development (SMAR&D) team has an opening for a Senior Specialist in our SMARD GxP Operations team based in Rahway, NJ. The primary objective of the SMAR&D GxP Operations team is to carry out analytical GMP activities partnering across the network to enable clinical supplies.  In your role as Senior Specialist, you will be part of a cross-functional team providing analytical support towards release of raw materials and package components.  We are seeking a hands-on, lab-based scientist to support GMP testing and document creation. The role will work collaboratively with colleagues in Pharmaceutical Operations and Global Development Quality to ensure timely release of raw materials and package components to enable advancement of our Company's research portfolio.

Primary Responsibilities

• Conduct excipient and package component release testing for our Research & Development Division according to cGMPs.

• Document experiments in a detailed manner in compliance with Standard Operating Procedures (SOPs) and Attributable, Legible, Contemporaneous, Original and Accurate (ALCOA ) principles.

• Interface with contract laboratories to ensure timely execution of outsourced GMP testing.

• Perform data review of laboratory notebooks and analytical reports.

• Author release specifications, analytical reports, certificates of analysis, investigations/deviation records, change records, and SOPs.  

• Work collaboratively with Development Quality and Materials Management to ensure on-time release testing of our raw materials and package components.

• Troubleshoot and lead any investigations associated with GMP testing through active collaboration with cross-functional project teams and/or Quality stakeholders. Identify appropriate corrective and preventative actions.

• Engage and participate in various internal and external current Good Manufacturing Practice (cGMP) audits or inspections.

• Represent the GMP functional area on a working group team.

Education Minimum Requirements:

Minimum 5 years relevant industry experience for applicants with a Bachelor of Science degree, or at least 2 years of relevant industry experience for applicants with a Master of Science degree in Chemistry, Pharmaceutical Sciences, or other Life Sciences.

 

Required Experience and Skills:

Excellent written and oral communication skills, as well as interpersonal skills, are necessary to qualify for this role. Candidates will also be required to work in a team environment with cross-functional interactions.

Preferred Experience and Skills:

Though not required, the ideal applicant would have hands-on experience in GMP operations, excipient or package component release testing, spectroscopy analysis, and other analytical techniques.  In addition, experience with electronic notebooks and SAP QN are also a plus.

#eligibleforERP

#AR&D

Required Skills:

Accountability, Accountability, Adaptability, Analytical Chemistry, Clinical Data Interpretation, Communication, Cross-Functional Teamwork, Data Analysis, Experimentation, GMP Compliance, Good Manufacturing Practices (GMP), Lab Equipment Maintenance, Laboratory Analysis, Laboratory Management, Laboratory Testing, Oral Communications, Personal Initiative, Preventive Action, Raw Material Procurement, Regulatory Compliance, Release Testing, Reviewing Literature, Scientific Research, Small Molecule Screening, Statistical Analysis { 3 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

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

$104,200.00 - $163,900.00

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 https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (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):

n/a

Job Posting End Date:

10/21/2025

*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:R369880

Salary : $104,200 - $163,900