Director, External Capabilities, Analytical Capabilities and Operations (ACO)

MSD; Rahway (NJ); On-site; USD 173,000 - 273,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Comprehensive benefits package

Job summary

Merck & Co., Inc. in Rahway, NJ, seeks a Senior Leader to head the Pharmaceutical Analysis and Digital Technologies group within Development Sciences and Clinical Supplies.

You will manage a team of ~10–12 scientists and oversee externalized analytical deliverables for large molecule programs across development stages. The role drives externalization strategy, ensures GMP-compliant documentation, collaborates with Process, Quality Assurance and Manufacturing, and develops talent within the team.

Qualifications

• Strong leadership and cross-functional collaboration skills.
• Experience leading externalization of analytical deliverables.
• Extensive knowledge of GMP and regulatory HA guidelines.

Responsibilities

• Execute DSCS externalization strategy and optimize operating model.
• Oversee analytical deliverables and external QC documentation.
• Transfer methods to commercial QC labs and ensure compliance.
• Collaborate with Process, QA, and Manufacturing to support external partners.

Skills

Adaptability

Analytical Chemistry

Analytical Method Development

Analytical Thinking

Biologics License Application (BLA)

Chemistry

Chromatographic Techniques

Commercialization

Drug Development

Laboratory Research

People Leadership

People Management

Pipeline Development

Regulatory Compliance

Regulatory Submissions

Scientific Analysis

Scientific Research

Team Leadership

Education

Ph.D. degree with 8+ years experience

Master’s degree with 10+ years experience

Bachelor’s degree with 15+ years experience

Job description

**Job Description****Job Description:** The selected candidate will work in the Pharmaceutical Analysis and Digital Technologies department within the Development Sciences and Clinical Supplies organization and lead a group of exceptionally talented scientists supporting externalized analytical deliverables for large molecule programs at various stages of development. The scope of the role will include realization of the Development Sciences and Clinical Supplies externalization strategy, driving a culture of scientific and operational excellence within our team and at our external partners, and developing talent to achieve exceptional results. The selected candidate will manage a team of ~10-12 scientists and manage a broad portfolio of Biologics, Antibody Drug Conjugate, and/or Vaccine programs. The leader will be expected to demonstrate subject matter expertise across large molecule analytical method development and qualification, proficiency in Quality Control and ability to manage relationships with strategic partners. The leader will work with internal stakeholders across Process, Quality Assurance, and Manufacturing to ensure an external network exists to supplement internal capacity and capability and drive transformation at external strategic partners by leveraging our company’s ways of working. The leader will be expected to work with direct reports and leverage their strengths to drive results while identifying opportunities to further develop each individual in alignment with their unique development plan. This role represents an excellent opportunity for a candidate seeking to lead a team of talented scientists, provide oversight of multiple programs, operate at the interface of clinical supply and commercialization, and broaden their experience in large molecule CMC development. **Primary Responsibilities:** * Execution of DSCS’s externalization strategy and optimization of the operating model to deliver results aligned with enterprise goals.* Oversee analytical deliverables, inclusive of quality control, for all drug substance and drug product deliverables sited at external partners to ensure continuity of clinical supply (analytical method qualifications/transfers, and resolution of analytical issues under GMP regulations)* Oversee external analytical capability build by working with internal SMEs to upskill strategic partners.* Oversee transfer of methods to commercial QC laboratories in support of registrational targets.* Ensure high-quality documentation from external partners consistent with a compliance mindset.* Work with ACO leadership to optimize current operating model and shape the future direction of the team in order to bring promising pipeline candidates to patients.**Education Minimum Requirements:** * A Ph.D. degree with a minimum of 8 years of experience* OR a master’s degree with a minimum of 10 years of experience* OR a bachelor’s degree with a minimum of 15 years of experience**Preferred Experience & Skills:** * Outstanding communication, critical thinking, and negotiation skills.* Project management experience including resource management, budget forecasting, and risk assessment/mitigation planning.* Comfort with working in a fast-paced and dynamic environment.* Strong knowledge of Biologics CMC landscape including knowledge of GMP and relevant HA guidelines.* Experience with a wide variety of analytical methods, including microbiological, device, potency assay, biochemical and/or biophysical characterization.* Experience working at the development/commercialization interface with a track record of moving pipeline assets to commercial products.* Demonstrated track record of working across networks to deliver exceptional results.* Demonstrated ability to critically review and interpret complex scientific and technical data to drive data-driven decision making* Travel (Domestic and/or International) up to 10% of time #AR&D**Required Skills:**Adaptability, Analytical Chemistry, Analytical Method Development, Analytical Thinking, Biologics License Application (BLA), Chemistry, Chromatographic Techniques, Commercialization, Drug Development, Laboratory Research, People Leadership, People Management, Pipeline Development, Regulatory Compliance, Regulatory Submissions, Scientific Analysis, Scientific Research, Team Leadership**Preferred Skills:**Current Employees apply HERECurrent 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:EEOC Know Your RightsEEOC GINA SupplementWe 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.Learn more about your rights, including under California, Colorado and other US State Acts The primary location for this posting is:USA - New Jersey - Rahway Where required by law, the compensation range for this role is provided below. The salary range for the primary location of this role is:$173,200.00 - $272,600.00 This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of 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. **Additional location(s):** Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location. **Additional location(s) Compensation Information:****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:**11/15/2026**\\*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.**Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.