Director, Microbiology GMP Operations AR&D

Job Description

Job Description:

Our Research and Development Division's microbiology team is seeking a Director for the Rahway NJ GMP microbiology operations.- The primary objective of the position is to oversee GMP environmental monitoring and microbiological release of pipeline products.- The director will provide guidance, lead activities, and strengthen a team of microbiologists whose roles include executing analytical methods to release clinical drug substance and drug product and support both non-sterile and sterile manufacturing.- This role contributes to the Development Sciences and Clinical Supplies (DSCS) deliverable, which involves the development of robust chemical and biochemical processes, market formulations, and their processes for non-sterile and sterile products. The Director will also collaborate with Development Quality, Pharmaceutical Operations, the other Research and Development Division Microbiology labs in the network and partners in commercialization and manufacturing in aspects of quality control, compliance, and strategic partnering.

Primary Responsibilities:

• Reports to the Executive Director of Microbiology in Analytical Research and Development (AR&D)
• Leads an expanding team of operational scientists at the Rahway NJ site.
• Responsible for clinical release for various processes and dosage formulations.
• Engages with the microbiology leadership team and extended leadership teams to advance departmental strategic and cultural initiatives.
• Identifies, recruits, onboards, and develops employees.
• Establishes a viable succession plan for key positions.
• Ensures cGMP compliance and operational excellence in the laboratories.
• Maintains a state of inspection readiness.
• Performs proactive resourcing planning and risk assessment strategies.
• Advances a culture of scientific excellence, GMP compliance mindset, and collaboration with various partners and stakeholders in other development departments.

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Essential Knowledge & Skills:

• Pharmaceutical Microbiologist (Direct GMP Operations Experience).
• Strong people management skills.
• Extensive experience with sterile operation and sterile testing laboratories.
• Demonstrated ability in leading teams and talent development.
• Project management skills.
• Ability to work in a team environment with cross-functional interactions.
• Excellent scientific communication, interpersonal, and collaborative skills.
• Strength in delivering results on firm deadlines.
• Experience representing the laboratory for internal and external audits.
• Leads microbiological investigations
• Review and approval of data and reports.
• SOP development.
• Quality System experience.
• Thorough working knowledge of GMPs, ICH, Pharmacopoeia, and relevant FDA guidelines.
• Desire and ability to learn new concepts outside of core expertise and training

Education Minimum Requirements:

• BS or MS in Microbiology/Molecular Biology or related science with at least 10 years of industrial experience leading a QC lab and working together with operations.
• Ph.D. in Microbiology/Molecular Biology or related science with 5 years of industrial experience leading a QC lab and working together with operations.

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#AR&D

Required Skills:
Accountability, Accountability, Adaptability, Analytical Method Development, Biologics License Application (BLA), Chromatographic Techniques, Communication, Decision Making, Dosage Forms, GMP Compliance, Immunochemistry, Innovation, Inspection Readiness, Learning New Concepts, Manufacturing, Microbiological Analysis, Microbiology, Molecular Biology, Molecular Microbiology, People Leadership, Pharmaceutical Guidelines, Pharmaceutical Microbiology, Process Analytical Technology (PAT), Professional Networking, Quality Control Management {+ 5 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
$169,700.00 - $267,200.00

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/International

VISA Sponsorship:
Yes

Travel Requirements:
10%

Flexible Work Arrangements:
Not Applicable

Shift:
Not Indicated

Valid Driving License:
No

Hazardous Material(s):
N/A

Job Posting End Date:
11/28/2025
*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: R370562