Director, Quality Control Chemistry & Raw Materials

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.

 

The QC Laboratory at Wilmington Biotech Campus will be a transformational facility for the analytical commercialization of our company’s pipeline of high potent Biologics including deep pipeline of Antibody Drug Conjugates. 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, GQLMAS Quality Control Operations Site Lead, the Director of Chemistry & Raw Materials will provide strategic and operational leadership for analytical chemistry testing of raw materials, in-process samples, and product testing at our Company's Wilmington site. This role ensures robust, compliant and timely analytical support from commercialization through in-line testing for biologics, drives method lifecycle management for separation-based assays, overseeing raw material testing & strategies, and contributes to site and global analytical support as a member of the GQLMAS organization.

Key Accountabilities:

• Specific for New facility & laboratory start-up:
  • Lead start-up activities for the chemistry and raw materials laboratories, including laboratory design, operational readiness, equipment commissioning, qualification and validation, and implementation of compliant laboratory systems and workflows.
  • Establish chemistry and raw materials testing capabilities, including compendial method suitability and verification, analytical method transfers and validation, sampling and testing strategies, and supplier-related testing requirements.
  • Partner closely remotely & on-site with other of our Company' global biologics sites to develop, implement & align on optimized operations strategies for the Wilmington Biotech QC laboratories.
• Routine Accountabilities:
  • Provide strategic and operational leadership for separations and raw materials analytical programs, including method validation/qualification, transfer, and commercialization.
  • Manage day-to-day operations of separations and raw materials laboratories ensuring inspection-ready compliance with cGMP, corporate policies and regulatory expectations.
  • Own analytical strategies for incoming raw materials, excipients, critical reagents and supplier quality interactions; establish risk-based testing and specification approaches in partnership with Procurement and Supplier Quality.
  • Oversee chromatographic and separation-based method execution and life-cycle management, ensuring scientific rigor and regulatory readiness.
  • Lead investigations for separations and raw materials related OOS/OOT events, stability trends and technical deviations; drive root cause analysis and CAPA implementation.
  • Partner with our Research & Development Division, Manufacturing, Quality and Regulatory to support CMC filings, regulatory inspections and network method transfers and validations.
  • Ensure robust documentation: SOPs, protocols, validation reports, technical reports and supplier testing records; act as reviewer/approver as delegated.
  • Develop and maintain laboratory capability strategy and capital plan for separations instrumentation and raw materials testing needs.
  • Manage departmental budgets for separations and raw materials operations; ensure cost-effective use of resources and consumables.
  • Build, lead and develop a high-performing team of analytical scientists, supervisors and technicians; deliver workforce planning, performance management and succession planning.
  • Champion continuous improvement, data integrity and digital enablement within separations workflows.

Qualifications / experience

• Minimum of Bachelor’s degree in a technical discipline, such as biochemistry or chemistry, or equivalent. A Master’s degree or PhD is preferred.
• At least 12 years of experience in the biotechnology and/or pharmaceutical industry; experience with ADCs is preferred.
• Demonstrated technical expertise in separations, method validation, and technology transfer for biologics.
• Experience managing raw materials testing programs and supplier quality interactions in a regulated environment.
• Proven ability to lead a QC laboratory team or equivalent; successful regulatory inspection experience is preferred.
• Strong leadership experience, including people management, budget management, and cross-functional stakeholder engagement.

Core competencies and skills

• Sound knowledge of regulatory expectations, including ICH Q2/Q14 and USP <1220>, and quality systems.
• Strong problem-solving, risk assessment, and decision-making skills.
• Effective communication and influencing skills, including experience presenting technical content to regulatory bodies.
• Project and change management capability; experience with digital tools and laboratory automation is advantageous.

Additional Info:

• Location: Wilmington, Delaware

• Ability to travel ~25% of the time.

• Team size: 20-30 FTE

Required Skills:

Analytical Instrumentation, Analytical Method Transfer, Analytical Testing, Biochemistry, Chemical Analysis, Chemistry, Chromatography, Coaching Feedback, Commercialization, Equipment Qualification, Good Manufacturing Practices (GMP), Laboratory Operations, Laboratory Setup, Laboratory Techniques, Microbiological Analysis, People Leadership, Process Chemistry, Process Testing, Quality Control Systems, Raw Material Analysis, Separation Techniques, Talent Development, Technical Transfer

Preferred Skills:

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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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:

25%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

09/29/2026

*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.