Analytical Project Lead (Associate Principal Scientist)

Job Description At our company, we aspire to be the premier research-intensive biopharmaceutical company. We're at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. Join us in our mission to use the power of leading-edge science to save and improve lives around the world. The Analytical Project Lead role includes driving analytical strategy, managing analytical procedure lifecycle activities, maintaining a robust assay monitoring effort, participating in product strategy discussions, global method ownership, and many other cross‑functional activities. This position requires effective collaboration with external contract providers as well as colleagues in research laboratories, supply chain, site, global Quality, and CMC‑Regulatory. Responsibilities Collaborate across the internal network, external partners, international governments and/or contract manufacturing & research organizations (CMO/CRO) in large molecule analytics Coordinate with analytical and process development groups to prepare for and coordinate analytical troubleshooting, validation and technology transfers between our company, external partners and CMO/CROs Guide cross‑functional teams and ensure alignment with analytical strategies and Quality Systems in support of analytical procedure lifecycle management Steer teams of subject matter experts to develop and optimize existing biochemical, immuno‑chemical and chromatography‑based analytical methods to enable modernization of our testing strategies Accountability for analytical method transfers and in‑line assay method validations, including review of protocols and reports Routine assay monitoring and trending to ensure a robust analytical testing network Ownership of product‑specific global analytical methods including routine evaluation of methods for analytical lifecycle changes Escalation of key project challenges to management in a timely and concise manner Partnership with critical reagent and reference standard groups to ensure unconstrained supply of reagents required for routine analytical testing Perform technical review of analytical change requests, atypical analytical results, Out‑Of‑Specification results, and analytical methods Coordinate analytical issue resolution via subject matter experts within the global large molecule network Qualifications Required Bachelor's Degree with a concentration in sciences with eight (8) years of experience working in the field of analytical testing, development, transfer, and/or validation; OR Master's Degree with six (6) years; OR PhD with three (3) years Effective communication and teamwork Experience with large molecule GMP testing including drug substance and drug product stability and release testing Experience with analytical comparability Experience leading a cross‑functional team Strong technical expertise in general large molecule analytical laboratory operations, equipment and techniques Preferred Continuous improvement or Project Management training Experience with global product supply Writing or reviewing of regulatory filings (IND, MAA, BLA, PAS, CBE) and inspections with multiple agencies (FDA, EMA, JNDA) Experience with large molecule analytical transfers Experience with change controls Experience with assay monitoring and trending Required Skills Adaptability Adaptability Analytical Method Development Analytical Testing Assay Assay Development Biochemical Assays Biological Assay Development Cell‑Based Assays Chromatographic Techniques Collaborative Communications Cross‑Functional Teamwork Effective Written Communication External Collaboration Global Product Management Global Supply Chain GMP Compliance GMP Operations GMP Training High Resolution Mass Spectrometry (HRMS) In Vitro Assays Liquid Chromatography‑Mass Spectrometry (LC‑MS) Management Trainings Mass Spectrometry Analysis Optimism {+ 7 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: EEOC Know Your Rights EEOC GINA Supplement Salary and Benefits 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. 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 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. Employee Status: Regular Relocation: No relocation 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: 07/11/2026 *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: R404076 #J-18808-Ljbffr Merck & Co.