Associate Director, Quality Control

Merck•Elkhorn, NE

2d•$129,000 - $203,100•Onsite

About The Position

US Analytical Technology Solutions (US-ATS) supports all Animal Health sites globally in analytical method development, improvement, validation, transfer as well as in all kinds of analytical investigations. This position will lead and oversee all aspects of analytical life cycle management activities for in-line licensed products including collaboration with cross-functional teams to ensure that deviations are resolved in a timely manner, and that corrective actions are effectively implemented. The Analytical Technical Solutions (ATS) Site Lead provides strategic, scientific, and operational leadership for analytical development activities across US sites. The role ensures compliant, efficient, and innovative analytical support for biologics, vaccines, and biotherapeutics while enabling cross‑functional alignment, regulatory readiness, and business continuity. This position is in Elkhorn, Nebraska-US site. The position may require up to 10% of domestic and/or international travel.

Requirements

PhD (or DVM) in Biology, Life Sciences, Virology, Veterinary Medicine discipline, or related biomedical sciences with 3+ years of relevant industry experience and/or equivalent combination of work experience OR Master’s degree with 5+ years of experience; OR Bachelor's degree with 7+ years of experience
Extensive knowledge of US, European, and international veterinary drug development requirements for both companion and production animals.
Proven leadership experience managing technical teams, laboratory operations, and external partnerships or CRO collaborations.
Deep expertise in bioanalytical techniques including ELISA, ligand-binding assays, protein chemistry, molecular biology, immunoassays, and cell-based assay development for biologics and large molecules.
Demonstrated experience with analytical method development, transfer, qualification, validation/co-validation, transfer and continuous method improvement.
In-depth knowledge and experience performing root cause analysis to determine process and system failure modes. Ability to apply advanced root cause analysis (RCA) tools (e.g., 5 Whys, fishbone, 8STP etc.) to drive thorough and effective investigations
Strong understanding of global regulatory requirements and experience supporting or authoring analytical sections in regulatory submissions for veterinary products.
Ability to influence and lead cross-functional teams, drive strategic initiatives, and collaborate effectively in a matrixed environment.
Strong project management skills, with experience managing multiple projects simultaneously across various stages of development.
Excellent communication, organizational, and problem-solving abilities, with demonstrated success in technical leadership roles within the biotechnology or biopharmaceutical industry.
Proficiency in Microsoft Office (Excel, Word, PowerPoint), SoftMax, JMP and experience with biologics manufacturing processes strongly preferred.
Analytical Problem Solving
Analytical Thinking
Assay
Biological Analysis
Biopharmaceutical Industry
Cross-Functional Teamwork
Root Cause Analysis (RCA)
Root Cause Investigations
Technical Leadership

Nice To Haves

Proficiency in Microsoft Office (Excel, Word, PowerPoint), SoftMax, JMP and experience with biologics manufacturing processes strongly preferred.

Responsibilities

Serve as a primary ATS liaison for Elkhorn Site (Site Lead), acting as the primary point of contact for Tier meetings and cross-functional site-level forums with BTS, Quality, and other operational stakeholders.
Provide strategic leadership to an analytical matrix team across multiple US sites to oversee biologics assay development, validation, transfer, improvement, and implementation for viral and bacterial vaccines as well as other biotherapeutics. Aligns site-level goals with broader organizational strategies and global analytical capabilities.
Implementation, qualification, and life-cycle management of analytical methods (compendial and product specific) supporting raw materials, drug substance, and drug product testing.
Develop, communicate, and execute strategic plans aligned with portfolio and pipeline priorities to ensure timely, high-quality analytical data delivery.
Collaborate closely with cross‑functional partners including QC, R&D, Regulatory Affairs, Quality Assurance, Manufacturing, and site functional leaders to drive integrated development and testing strategies.
Immediately upon assignment of an investigation, create and/or partners with the investigation team (SMEs and necessary stakeholders) on definition and alignment of the investigation plan, required data, and timing for completion. Continue to partner with investigation team throughout the investigation process to ensure agreement / alignment on root cause and CAPA.
Ensure compliance with global regulatory expectations (EMA, VSM/VICH/USDA, USP, ICH, GLP, etc.) and contribute to regulatory submissions, inspections, and dossier authoring.
Provide scientific and analytical oversight for cGMP documentation, method qualification/validation protocols and reports, method transfer documentation, and specification justifications.
Drive innovation by identifying, evaluating, and implementing new technologies and analytical methodologies, including ELISA, ligand-binding assays, biochemical, immune-, molecular-, and cell-based assays.
Interpret complex scientific data, troubleshoot analytical issues, and develop scientifically sound solutions that meet program and regulatory requirements.
Drive continuous improvement and operational excellence through standardization, data integrity initiatives, harmonized procedures, and best practices across sites.
Lead proactive resources and capacity planning to ensure alignment with development strategy and program timelines aligned with business priorities.
Support Primary and Working Reference standard and critical reagent management, including qualification, aliquoting and long-term management across all end users of the materials.