Associate Director, Quality Control

Job Description

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.

Primary 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.

Education

• 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

Experience and Skills

• 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.

Required Skills:

Analytical Problem Solving, Analytical Thinking, Assay, Biological Analysis, Biopharmaceutical Industry, Cross-Functional Teamwork, Root Cause Analysis (RCA), Root Cause Investigations, Technical Leadership

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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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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The salary range for this role is

$129,000.00 - $203,100.00

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 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

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

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

Yes

Hazardous Material(s):

Yes

Job Posting End Date:

06/24/2026

*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.