Assoc Dir. - Vaccine Analytical Projects and Process Improvements

Biopharma Careers; West Point (MS); On-site; USD 142,000 - 224,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision care

Job summary

Merck & Co., Inc. in Rahway, NJ seeks an Associate Director to lead a team of scientists driving vaccine-focused analytical projects in quality control labs.

Responsibilities include overseeing method validation, transfers, instrument replacements, and equipment qualification across the commercial vaccine testing portfolio. The role emphasizes people and project leadership, prioritization, and cross-functional collaboration with manufacturing, QA, CMC-Regulatory, and external labs to ensure

Qualifications

• Experience leading scientific or technical teams with coaching and performance management.
• Strong background in GMP Quality Control analytical testing for vaccines.
• Experience with analytical method lifecycle management, validation, transfer, and implementation.

Responsibilities

• Lead scientific/technical teams and manage project priorities and escalation.
• Oversee vaccine analytical testing across multiple programs and labs.
• Drive instrument replacement, method replacement, and modernization projects.
• Ensure compliance and timely execution in a fast-paced lab environment.

Skills

Analytical Chemistry

Method Transfer

GMP Quality Control

Project Management

People Leadership

Budget Management

Data Analysis

Design of Experiments

Instrument Qualification

Deviations Investigations

Education

Bachelor's degree in vaccine analytical testing

Master's degree in related field

PhD in related field

Tools

GMP Laboratory Systems

Job description

We are seeking an Associate Director to lead a team of scientists responsible for vaccine-focused analytical projects supporting vaccine quality control labs. This role will oversee high-priority initiatives across the commercial vaccine testing portfolio, including instrument replacements, method replacements, analytical method transfers, method validation and implementation support, equipment qualification, and method modernization. The role will be located in West Point, PA.

The Associate Director will provide people leadership, project leadership, prioritization, and escalation support to ensure reliable, compliant, and sustainable vaccine analytical testing. The role requires strong collaboration across West Point Quality Laboratories, GQ-LMAS, manufacturing, technical support, engineering, development, Quality Assurance, CMC-Regulatory, and external laboratory partners.

The successful candidate will be a strong scientific and project leader with experience in GMP Quality Control, vaccine analytical testing, method lifecycle management, and cross-functional execution in a fast-paced laboratory environment.

Education Minimum Requirement:

Bachelor’s degree with eight (8) years, Master’s degree with six (6) years, or PhD with four (4) years of relevant experience in vaccine analytical testing, quality control, method validation, method transfer, technical operations, laboratory project execution, or project leadership.

Required Experience and Skills:

• Experience leading scientific or technical teams, including coaching, prioritization, performance management, and talent development.
• Strong background in GMP Quality Control analytical testing, preferably supporting commercial vaccine products.
• Experience with analytical method lifecycle management, method validation, method transfer, technical change implementation, and QC method sustainment.
• Experience managing analytical projects across multiple vaccine programs, laboratories, or technical areas.
• Experience with instrument replacement, equipment qualification, method replacement, method modernization, analytical transfer, or test method implementation projects.
• Strong organizational, project management, communication, and escalation skills.
• Ability to influence decisions and drive execution in a matrixed West Point site and global quality environment.

Preferred Experience and Skills:

• Experience supporting vaccine analytical testing in a West Point Quality Laboratory or comparable commercial vaccine QC environment.
• Experience with vaccine analytical methods such as bioassays, immunoassays, chromatography, biochemical, biophysical, molecular, microbiological, or characterization methods.
• Experience with deviations, laboratory investigations, change control, assay monitoring, data trending, continuous improvement, inspection readiness, or regulatory support.

Required Skills:

• Analytical Chemistry
• Analytical Chemistry
• Analytical Method Transfer
• Bioanalytical Analysis
• Bioanalytical Techniques
• Budget Management
• Data Analysis
• Data Review
• Design of Experiments (DOE)
• Deviation Investigations
• Dosage Forms
• Identifying Customer Needs
• Immunoassays
• Instrumental Analysis
• Laboratory Research
• Mentoring Staff
• Method Development
• Method Improvement
• Method Validation
• People Leadership
• Process Improvements
• Project Engineering
• Project Management
• Research Development
• Technical Transfer {+ 4 more}

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:

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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.

Learn more about your rights, including under California, Colorado and other US State Acts

The salary range for this role is $142,400.00 - $224,100.00

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.

Benefits

• medical
• dental
• vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days

More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

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: No relocation

VISA Sponsorship: No

Travel Requirements: 10%

Flexible Work Arrangements: Not Applicable

Shift: 1st - Day

Valid Driving License: No

Hazardous Material(s): NA

Job Posting End Date: 09/19/2026 *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:R414588