GQ-LMAS - Vaccine Methods Team Lead

Job Description

We seek a candidate to lead a team of subject matter experts (SMEs) providing in-depth technical support for vaccine analytical methods as a member of the Global Quality Large Molecule Analytical Sciences – Central Vaccine Labs Team. Analytical testing is critical to the assessment of vaccine product quality, potency, purity, identity, safety, stability, and process consistency. Methods support by this team include bioassays, immunoassays, biophysical methods, chromatography, biochemical and physicochemical methods, characterization methods, and other platform or product-specific assays used for release, stability, investigational, process development, and lifecycle management purposes. This team is highly motivated, fast paced and focused on ensuring consistent compliant supply of our vaccine franchises while advancing analytical lifecycle initiatives. This position will manage subject matter experts across our vaccine franchises, with special emphasis on HPV and PCV, and will provide technical oversight of analytical testing supporting our Company’s inline vaccine products

The candidate will be expected to provide guidance, expertise and support for analytical methods established within our commercial laboratories. This support is provided through a network of subject matter experts and partner organizations. The method lead and their team will interface with colleagues in quality laboratories, site-based technical support functions, critical reagent and reference standard hubs, project teams across the company as well as external laboratory partners. This position will require effective collaboration with colleagues in our research laboratories, statistical & modeling groups, process and product development teams, as well as CMC-Regulatory. The lead will be responsible for coordinating the activities of their direct reports using outcome-driven performance plans and ensuring SME support is aligned to franchise priorities and business needs.

Effective communication and teamwork are required with both internal and external partners. Global technical support is provided for methods at all internal and external testing sites, and the candidate is expected to foster effective external collaborations working with multiple partners including sourcing and procurement functional areas. Working with colleagues in Global Quality Large Molecule Analytical Sciences, the candidate will be a key partner in analytical lifecycle management activities, helping to identify key components that influence method performance and developing risk abatement strategies. The lead will also directly oversee and/or assist with driving strategies for reference standards, critical reagents, assay controls, method platforms, and other key materials or processes that impact analytical performance and robustness.

Key activities supporting the team mission of providing world-class technical support for vaccine testing include: method lifecycle management, reference standard and critical reagent strategy, support of analytical investigations, regulatory submission support, method optimization, assay and method performance monitoring, input on method template designs, coordination of testing strategy, working with partners to optimize workflows, troubleshooting workshops, technical risk assessments, method validation and transfer support, and method modernization activities. The candidate should be a strong technical leader and troubleshooter with broad analytical testing expertise, vaccine franchise experience, and the ability to connect method performance to product quality, regulatory expectations, and business priorities.

Education Minimum Requirement:

• 15 years of industry experience plus a Master’s or Bachelor’s degree or
• 10 years of industry experience plus a PhD degree working directly in the field of analytical testing, development and/or validation.

Required Experience and Skills:

• Must have a strong Quality control background with demonstrated experience supporting GMP analytical methods, including defending technical content during health authority inspections and writing/reviewing regulatory technical questions.
• Ability to lead teams demonstrated through 3 key levers:
• Experience as a direct manager of technical experts, including goal setting, development planning, performance management, financial budget and department resources.
• Experience as a cross-functional leader with the ability to drive right first-time execution of projects/testing, while maintaining strong relationships and collaborative mindset.
• Demonstrated examples of driving change across the global environment in a positive way.
• Demonstrated experience with Analytical Method Validation and relevant compendial guidelines, such as ICH Q2/Q14, as well as analytical tech transfer.
• 10 + years of analytical testing or development experience with assay validation and troubleshooting expertise across a broad method and portfolio set.
• Demonstrated ability leading technical teams and mentoring and developing scientific talent.
• Incumbent must have excellent interpersonal, communication, and collaboration skills.
• Strength in delivering results on firm deadlines in support of drug/vaccine development and commercialization
• Broad expertise with vaccine analytical testing, including bioassays, immunoassays, biophysical methods, chromatography, biochemical and physicochemical methods, characterization methods, and other platform or product-specific analytical methods, with preferred experience supporting recombinant and conjugate vaccines.
• Development and management of project timelines and deliverables.
• Authoring and reviewing technical documents.
• Ability to work independently and within a cross-functional team.

Required Skills:

Preferred Skills:

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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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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

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

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Requisition ID:R414888