Director of GMP Site Operations, Small Molecule AR&D

Job Description

The Pharmaceutical Analytical Sciences team has an opening for a director 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 this role, the Director will lead a team of specialists and scientists in Rahway supporting various GMP analytical activities including cleaning verification, solvent release, and in-process testing for drug substance and drug product across the entirety of our non-sterile clinical portfolio during 1st and 2nd shift operations at the Rahway site. This particular role is fully onsite during 1st shift operations. 

The Director is responsible for ensuring cGMP compliance and operational excellence in the laboratories, and for always maintaining a state of inspection readiness.  The Director should be engaged with regulatory and industry trends and have thorough working knowledge of GMPs, ICH, and relevant FDA guidelines.

In addition, the Director will effectively team with the Pharmaceutical Analytical leadership, and extended leadership teams to identify and advance key departmental strategic and cultural initiatives. The Director will identify, recruit, onboard, and develop employees to their full potential. The role will also be responsible for proactive resourcing planning, risk assessment strategies, and budget management as necessary.

Primary Responsibilities

 

• Leading a team of specialists and scientists supporting cleaning verification, solvent release, and in-process testing for drug substance and drug product during 1st and 2nd shift operations

• Ensuring on-time, right first-time analytical testing of to enable clinical manufacture of drug substance and drug product

• Provide technical and compliance oversight on lab investigations and deviations

• Review and approval of GMP data, release specifications, analytical reports, Certificates of Analysis, and SOPs.

• Serve as the site-based analytical support lead during internal and external compliance audits

• Ensure operational excellence and drive process improvements

• Staff development and talent recruiting

• Work with the leadership team to help drive departmental strategic and cultural initiatives

Education Minimum Requirements:

• BS or MS in chemistry or related science with at least 10 years of industry experience with pharmaceutical drug substance and/or product development.

• Ph.D. in chemistry or related science with at least 7 years of industry experience with pharmaceutical drug substance and/or product development.

   

Required Experience and Skills

• Excellent scientific communication skills, demonstrated creativity, effective interpersonal and collaborative skills

• Demonstrated ability to lead teams to deliver high-quality results against firm deadlines

• Proven talent development skillsets

       

• Ability to partner in a team environment with cross-functional interactions to drive results

Preferred Experience and Skills

• Though not required, the ideal applicant would have prior experience managing a GMP analytical lab that supports cleaning verification, IPC, and solvent release.  Prior experience with lab investigations/deviations and compliance audits is a plus.

Required Skills:

Adaptability, Adaptability, Analytical Method Development, Biologics License Application (BLA), Chromatographic Techniques, Compliance Oversight, Decision Making, Dosage Forms, Drug Screening, GMP Compliance, Inspection Readiness, Internal Resourcing, Operational Excellence, People Leadership, Pharmaceutical Sciences, Process Analytical Technology (PAT), Product Development, Professional Networking, Regulatory Compliance, Regulatory Submissions, Results-Oriented, Risk Assessments, Risk Evaluation And Mitigation Strategy (REMS), Science Communication, Talent Development {+ 2 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.

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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

$173,200.00 - $272,600.00

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:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

05/21/2026

*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.