QC Director, Lab Instrumentation, Digital Systems & Connectivity

Job Description

At our Wilmington Biotech Campus, we are committed to keeping the patient at the very heart of all that we do and striving to find solutions and treatments for some of the world’s most challenging healthcare needs.  

 

The Wilmington Biotech Campus will play a pivotal role in the manufacture of our company’s biologics-based medicines, including the areas of immuno-oncology. This site will establish our company’s internal capability to manufacture high potent compounds when full manufacturing operations begin in 2029. 

 

This facility will be a significant supplier of Antibody Drug Conjugates (ADCs) and High Potent Compounds and will also be critical in the future supply of new biotechnology products to its global network. 

 

Wilmington Biotech Campus – Quality Control Laboratory 

 

The Quality Control (QC) Laboratory at Wilmington Biotech Campus will be a transformational facility for the analytical commercialization of our company’s pipeline of high potent Biologics. This laboratory will bring together late-stage analytical method development and validation with commercial release testing to deliver significantly improved speed through the analytical lifecycle. The laboratory will be supported by locally based advanced analytical subject matter experts and digital tools to enable an enterprise-wide connected laboratory in support of a new approach to analytical commercialization for high potent Biologics. The laboratory will be operated under our Manufacturing Division with close collaboration with our Research & Development Division. 

 

Reporting to the Executive Director, Wilmington Laboratory Operations, the Director of Laboratory Instrumentation, Digital Systems & Connectivity is the senior technical leader accountable for the end-to-end design, start-up, and sustained operation of all laboratory instrumentation, digital laboratory systems, and enterprise connectivity platforms for the Wilmington Quality Control Laboratories. 

 

This role will be a critical leader in the new facility and laboratory start-up program — supporting laboratory design, ensuring all necessary instrumentation and digital functionalities are incorporated, and leading start-up to meet all deliverables according to schedule. The role will define and execute the strategic vision for a fully connected, digitally enabled, paperless laboratory environment, ensuring that instrumentation, chromatography data systems (CDS), laboratory information management systems (LIMS), electronic laboratory notebooks (ELN), and enterprise data platforms are seamlessly integrated to enable the end-to-end analytical lifecycle. This includes driving the adoption of advanced digital tools, automation, and data analytics to support a new paradigm for analytical commercialization of high potent Biologics. Post laboratory start-up, the role will provide ongoing strategic leadership for instrumentation lifecycle management, digital system optimization, and continuous improvement of laboratory connectivity and data integrity across the site. 

 

Key Accountabilities: 

 

New Facility & Laboratory Start-Up: 

• Support the design of the laboratory facility, partnering with Engineering, Quality, Digital, Manufacturing, and IT to ensure all necessary instrumentation, digital infrastructure, and connectivity functionalities are incorporated to support the end-to-end analytical lifecycle. 

• Lead the design and specification of laboratory infrastructure requirements as they relate to instrumentation and digital systems; partner with Engineering and IT teams to ensure fit-out and utility provisions meet requirements. 

• Develop and execute the integrated start-up master plan for instrumentation, digital systems, and laboratory connectivity, ensuring all deliverables are met according to schedule. 

• Define and execute the commissioning, qualification, and validation (CQV) strategy for all laboratory instrumentation and digital systems, including IQ/OQ/PQ protocols and validation master plans; develop the phased equipment delivery, installation, and qualification schedule aligned with facility construction milestones. 

• Support the execution of the laboratory operational readiness plan ensuring all systems are validated and inspection-ready prior to Health Authority submissions, including pre-approval inspection (PAI) readiness. 

• Support the development of EHS policies and practices for the laboratory as they relate to instrumentation and high potent compound containment. 

 

Instrumentation Lifecycle Management 

• Accountable for QC instrumentation strategy, selection, procurement, and delivery planning across all analytical platforms (HPLC/UPLC, mass spectrometry, spectroscopy, bioanalytical instruments, etc.) in partnership with global groups (Quality, IT, Digital, Analytical R&D, etc.) 

• Lead instrument commissioning, qualification (IQ/OQ/PQ), and validation programs ensuring right-first-time execution and regulatory compliance. 

• Develop and implement risk-based maintenance, calibration, and requalification strategies; manage vendor and qualification service provider relationships to ensure ongoing instrumentation is maintained in a fully validated and calibrated state, on schedule, on budget, and inspection-ready 

 

Quality & Compliance: 

• Accountable for instrumentation related activities including review and approval of SOPs, protocols, and qualification documentation 

• Serve as the subject matter expert during health authority inspections for instrumentation and laboratory systems. 

• Lead investigations for system-related deviations, OOS/OOT events, and data integrity incidents; drive root cause analysis and CAPAs. 

 

Strategic & Technical Leadership 

• Provide strategic direction and technical leadership for all laboratory instrumentation, digital systems, and connectivity platforms, ensuring alignment with site, network, and enterprise quality and digital objectives. 

• Partner with cross-functional stakeholders (IT, Quality, Engineering, Manufacturing, Regulatory, Digital) to align laboratory digital strategy with global quality, compliance, and digital transformation priorities. 

• Own the architecture and integration strategy for the connected laboratory ecosystem including LIMS, CDS (i.e. Empower), ELN, and enterprise data lakes 

• Deploy advanced analytics, dashboards, and real-time monitoring tools for proactive instrument performance management and predictive maintenance. 

• Champion automation, AI, and digital technologies to optimize laboratory throughput and data quality 

  

Qualifications / experience 

 

Education 

• Bachelor's degree in Analytical Chemistry, Biology/Biochemistry, Engineering, Computer Science, or related discipline. Advanced degree preferred.  

Experience 

• 12+ years of progressive industry experience in pharmaceutical/biotech laboratory operations with direct expertise in laboratory instrumentation, digital systems, and/or laboratory IT in a GxP environment. 

• Demonstrated experience with new facility/laboratory start-up, such as facility design input, CQV strategy and execution, start-up master planning, and Health Authority approval readiness (PAI preparation). 

• Expertise in LIMS, CDS (e.g., Empower), ELN, and instrument data management platforms. 

• Proven experience designing and/or implementing connected/paperless laboratory environments. 

• Strong understanding of data integrity requirements (ALCOA+, 21 CFR Part 11, EU Annex 11). 

• Strong Quality background with direct experience defending content during health authority inspections preferred. 

• Proven leadership including cross-functional stakeholder engagement 

• 5+ years leading a team in a regulated Quality laboratory environment. 

 

Core competencies and skills 

• Technical leadership in laboratory instrumentation and digital systems architecture 

• Deep expertise in laboratory IT, data integrity, and enterprise connectivity in GxP environments 

• Experience in data analysis, trending, and/or other types of digital media in the pharmaceutical/biotech industries strongly preferred 

• Proven track record in new laboratory/facility start-up from design through operational readiness 

• Experience implementing automation, advanced analytics, and/or AI in laboratory operations 

• Strong regulatory knowledge for computerized systems and instrument qualification 

• Effective cross-functional leadership and stakeholder influencing in greenfield environments 

• Knowledge of EHS requirements for high potent compound containment preferred 

 

Additional Info: 

• Location: Wilmington Delaware (On-Site) 

• Travel: Ability to travel ~10% of the time 

 

Required Skills:

Analytical Chemistry, Analytical Instrumentation, Antibody Drug Conjugates (ADC), Digital Diagnostic Equipment, Innovation, Laboratory Design, Laboratory Information Management System (LIMS), Laboratory Instrumentation, Mass Spectrometry (MS), Program Startup, Qualitative Testing, Quality Improvement Programs, Quantitative Assay, Spectrometry, Strategy Execution, Team Coordination, Technical Leadership

Preferred Skills:

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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

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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:

07/28/2026

*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.

Requisition ID:R407171