Job Description

The PDMB Regulated Bioanalytics Department is seeking a Director to lead the Compliance team within the Late Development (AdVAnce) Vaccines bioanalytical group located at our company's new state-of-the-art AdVAnce GxP research facility in West Point, PA. At this new facility, we will combine the power of innovative robotics, IT platforms, and science to accelerate vaccines and enable late-stage clinical trials through the generation of timely, high-quality regulated bioanalytical data. A combination of molecular (e.g., PCR), serology (e.g., ligand binding titer immunoassays), and cell-based assays (e.g., neutralizing assays) will be utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings. The compliance team will ensure all operations, documentation, procedures, and filings meet all regulations and will focus on both the setup of these processes along with ongoing improvements. As the AdVAnce facility will not be fully constructed and ready for occupancy until 2026, initial roles will complete training and perform work primarily at our company's Springhouse Innovation Park facility in Lower Gwynedd Township, PA.

The successful Compliance Director candidate will lead a team that focuses on the development, oversight, and improvement of labs processes, procedures, and data systems to ensure high-quality bioanalytical testing. Responsibilities will include technical writing (e.g. regulatory responses, SOPs, etc.), management of QA and regulatory inspections, review of data and lab processes, driving the evolution of systems and processes to ensure ongoing quality improvements, creating tracking mechanisms and monitoring lab key performance indicators (KPIs), and directly managing some lab operations (e.g. reagent prep, system validation, safety, etc.). As a member of the Late Development Vaccines bioanalytical leadership team, the candidate will partner with other leaders in the setup of the new facility and labs, recruitment of top talent, and establishing an innovative and inspiring culture.

Education Minimum Requirement

• B.A./B.S. in Biology, Immunology, Biochemistry, or a related scientific discipline with at least 15 years, M.S. with at least 10 years, or Ph.D. with at least 8 years of related experience

Responsibilities

• Provides leadership, mentorship, and coaching to managers to compliance team staff

• Leverages deep compliance, quality, and/or regulatory expertise to implement and improve lab processes, systems, and procedures.

• Leads technical writing of SOPs, bioanalytical procedures, deviations, investigations, trending reports, validation reports, filing documents and regulatory responses.

• Conducts review of all laboratory data to drive high quality documentation, data integrity, staff adherence to procedures

• Leverages IT tools to develop and utilize effective monitoring tools to track lab KPIs

• Manages select lab operation functions to support reagent preparation, computer system validations, documentation template creation, and other operational aspects of the lab not managed by the assay or robotics teams.

• Applies business and management expertise to set and achieve financial and operational objectives for the Compliance team

• Influences others internally and externally, including senior leaders, internal customers, and external partners

• Develops relationships with key stakeholders, including robotics, IT, quality, and other partnering organizations to drive improved, quality operations

• Contributes to the development of departmental strategy and represents department on leadership and development teams

• Develops priorities and objectives for the Compliance and Late Development team to align with division scorecard

• Represents the Late Development Vaccines team during internal and external audits

• Promotes our company’s scientific excellence and regulatory influence through leadership in the scientific community

Required Experience & Skills

• Experience working within a GLP, GMP, or other GxP laboratory

• Experience in Agency inspections/audits

• Experience with regulatory submissions

• Experience using various IT tools for laboratory testing/documentation (ELNs, LIMS, etc.), review, audit, and/or monitoring of quality metrics

• Demonstrated history of developing improved laboratory or quality processes

• Ability to lead, mentor, and inspire staff at various levels; encourages curiosity in others and challenges the status quo to foster innovation

• Demonstrated ability for taking initiative, creativity, and innovation in problem solving

• Strong ability to deliver complex objectives under aggressive timelines in a rapidly changing environment

Preferred Experience & Skills

• Project management skills

• Established scientific reputation supported by publications and/or external presentations

• Experience working in a GxP bioanalytical laboratory

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Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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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 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:

Yes

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Required Skills:

Assay, Auditing, Bioanalysis, Bioanalytical Assays, Business Management, Cell-Based Assays, Clinical Testing, Compliance Management, GxP Regulations, Immunoassays, Innovation, Mentoring Staff, Project Management, Quality Metrics, Regulatory Inspections, Stakeholder Relationship Management, Standard Operating Procedure (SOP) Development, Strategic Direction, System Validation, Talent Development, Team Leadership, Technical Writing

Preferred Skills:

Job Posting End Date:

09/26/2025

*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.