Job Description

The Associate Director, Analytical Technical Solutions is a senior leadership role within US Analytical Technology Solutions (US-ATS), accountable for analytical lifecycle management across early- and late-stage biologics, with emphasis on monoclonal antibodies (mAbs), vaccines, and protein therapeutics. The role oversees development, validation, transfer, and continuous improvement of chromatography- and LC-MS–based methods, provides subject matter expertise for drug substance and drug product release and characterization assays, and ensures seamless integration of analytical methods into manufacturing workflows. The position carries responsibility for leading a small team, guiding regional innovation initiatives, and maintaining robust collaboration across R&D, QC, QA, Regulatory Affairs, manufacturing, and external partners. Travel requirement: 10–25%.

Key responsibilities

• Lead analytical lifecycle management activities for biologics, including method development, validation, transfer, and comparability assessments
• Direct chromatographic and LC-MS platforms for characterization and release testing (e.g., intact/reduced mass, peptide mapping, glycan mapping, charge variants)
• Serve as subject matter expert for protein/mAb analytical control strategies, specification setting, stability program design, impurity profiling, and degradation pathway assessment
• Oversee site-to-site and R&D-to-site analytical transfers and integration into drug substance and drug product manufacturing processes
• Author, review, and approve analytical protocols, reports, test plans, and stability protocols; ensure compliance with GMP/USDA/FDA/ICH guidelines
• Lead and support investigations (OOS/OOT), root cause analysis, CAPA, and change control; partner with QC to evaluate method performance and assay robustness
• Maintain strong internal and external collaborations for assay development, validation, and lifecycle improvements
• Manage primary/working reference standards and critical reagents, including qualification, distribution, and long-term stewardship
• Plan and manage budgets, resources, and staffing; mentor and develop a high-performing team
• Oversee instrumentation strategy, including procurement, qualification, maintenance, and vendor management for HPLC, UPLC, FPLC, LC-MS, and related platforms
• Monitor and assess emerging analytical technologies; contribute to regional innovation leadership and technology introduction

Minimum requirements:

• Master’s degree with 9+ years of experience in analytical biochemistry, pharmaceutical sciences, molecular biology, biotechnology, or related discipline, with progressive technical leadership in large-molecule analytics;

OR -

• PhD with 6+ years of experience in analytical biochemistry, pharmaceutical sciences, molecular biology, biotechnology, or related discipline, with progressive technical leadership in large-molecule analytics
• Demonstrated expertise in mAb and protein therapeutic characterization; practical, hands-on experience with LC/UPLC/FPLC/SEC and LC-MS–based methods
• Proficiency across key analytical modalities: UV-Vis, SDS-PAGE, Western blot, CE-SDS, HPLC/UPLC/FPLC, HPLC-SEC, LC-MS, ELISA, activity assays; experience with cell-based assays preferred
• Proven leadership managing small teams (2–5 direct reports) and delivering complex method transfers and lifecycle management in a matrixed environment
• Comprehensive knowledge of GMP, USDA, FDA, ICH guidelines and bioprocess operations relevant to biologics manufacturing
• Competence in statistical evaluation of analytical data and use of CDS platforms such as Empower, Chromeleon, OpenLab ChemStation, or equivalent
• Experience in international, cross-functional project teams, with strong project management, communication, and stakeholder alignment skills

Preferred qualifications:

• Deep, hands-on expertise in biochemical analysis and characterization of monoclonal antibodies and protein therapeutics
• Experience driving analytical innovation initiatives and introducing new technologies across regional or global networks

Our Manufacturing & Supply Division operates an interdependent global network with external contractors, suppliers, and partners, focused on reliable, high-quality supply of Animal Health biopharmaceuticals to customers and patients—on time, every time. This role is positioned to evolve into a regional innovation team lead, advancing analytical lifecycle management and next-generation technologies across the network.

Required Skills:

Preferred Skills:

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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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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The salary range for this role is

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:

Relocation:

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Travel Requirements:

Flexible Work Arrangements:

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Requisition ID:R381658