Director, Pharmacokinetics; Regulated Bioanalytics, Exploratory Vaccines & Regulated Robotics, LIMS & Data Management

Job Description

Job Description 

 

Director (M3), Regulated Bioanalytics, Exploratory Vaccines & Regulated Robotics, LIMS & Data Management 

 

The PDMB Regulated Bioanalytics Department is seeking a Director to lead the Laboratory Information Management Systems (LIMS) & Data Management team within the Regulated Robotics & Data group.  This role will support work across groups within the Regulated Bioanalytics Department, including work 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 immunoassays), and cell-based assays (e.g., neutralization assays) will be utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings.  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 primary role of the successful candidate will be to set the strategic direction and implement LIMS and other data management tools within the regulated bioanalytical laboratory setting.  The position is accountable for the team delivering development, validation, enhancement, and oversight of LIMS systems or related modules that are used to track sample chain of custody records, analyze bioanalytical data, and handle data management.  This team will also develop and implement tools to increase the efficiency of processes, data review, and data visualization that can be applied to increase the throughput of our Vaccines pipeline.  

 

In this role, responsibilities include coaching and mentoring across the organization, being influential in program strategy cross-functionally across our company's portfolio and working across industry teams and with health authorities to develop bioanalytical guidance.  The incumbent will be responsible for the recruiting and development of talent under her/his supervision. 

 

Education Minimum Requirement 

B.A./B.S. in Biology, Chemistry, Biochemistry, Engineering, Data Sciences, Computer Science or a related 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 to individual contributors on LIMS & Data Management team 

• Represents LIMS & Data Management in early/late vaccine development teams and influences data strategies together with stakeholders 

• Provides oversight of development, testing, validation, and implementation of LIMS systems or related upgrades to meet the needs of various bioanalytical assays 

• Provides oversight of strategy, development, and validation of IT solutions for visualization tools for the review of experimental data and for IT tools used to track material through automated systems 

• Designs, assesses, and implements novel approaches and technology for data management 

• Identifies opportunities for new internal and external collaborations, engages collaborators, identifies business needs and values, and proposes proper solutions 

• Resolves complex technical, operational, and financial problems 

• Reviews and approves data as needed 

• Applies business and management expertise to set and achieve financial and operational objectives for the LIMS & Data Management team 

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

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

• Develops priorities and objectives for the LIMS & Data Management group to align with division scorecard 

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

 

Required Experience & Skills 

• Extensive experience utilizing or implementing custom or commercial LIMS in a regulated bioanalytical laboratory 

• Significant experience with software visualization programs 

• Familiarity with computer control concepts to assist in troubleshooting and implementing computer-based lab automation and instrumentation 

• Ability to lead, mentor, and inspire scientists 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 

• Experience in Agency inspections/audits   

• Experience with regulatory submissions 

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

• Excellent oral and written communication skills 

• Experience leading diverse teams and driving a collaborative and inclusive mindset 

 

Preferred Experience & Skills 

• Strong external scientific reputation including publications, regulatory guidance documents, presentations at scientific meetings, membership on (or leading) cross-company working groups or consortia 

• Experience working in a GLP bioanalytical laboratory 

• Project management skills 

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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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”.

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

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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:

04/11/2025

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