Reference Standard and Reagent Director

TN United Kingdom; Barnard Castle; On-site; USD 151,000 - 253,000; Full time

Job summary

An established industry player is seeking a Reference Standard and Reagent Director in Barnard Castle. This pivotal role involves ensuring the availability of critical reagents and analytical standards, managing a team, and collaborating with various stakeholders to maintain compliance and quality standards. The position offers a unique opportunity to influence strategic initiatives and drive innovation within the supply chain, making a significant impact on product development. If you have a strong background in chemistry and leadership, this role is perfect for advancing your career in a dynamic environment.

Benefits

Health Care

Retirement Plans

Paid Holidays

Qualifications

• 10+ years in R&D or GSC QC/QA projects.
• 5+ years in leadership roles with strategic execution experience.

Responsibilities

• Manage supply of reference materials and analytical standards.
• Lead internal teams and coordinate with GSK Quality & Compliance.

Skills

Chemistry

Project Management

Leadership

Analytical Skills

Regulatory Compliance

Problem-Solving

Education

Bachelor of Science in Chemistry

Job description

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Reference Standard and Reagent Director, Barnard Castle

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Client:

GSK

Location:

Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

7a1010becf70

Job Views:

3

Posted:

02.05.2025

Expiry Date:

16.06.2025

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Job Description:

Job description
Site Names: USA - Pennsylvania - King of Prussia, Belgium - Wavre, UK - County Durham - Barnard Castle, UK - Hertfordshire - Ware, USA - Maryland - Rockville, USA - Pennsylvania - Upper Providence
Posted Date: Apr 21 2025
The Reference Material and Reagents Director is accountable for ensuring the availability of critical reagents and analytical standards for the GSK network. They must meet regulatory standards and coordinate supply to GSK sites, CMO, and LOC to support the end-to-end supply chain of products to patients. The role involves ensuring long-term availability and lifecycle management of reference materials for existing and new GSK products. It also includes maintaining outsource partners to ensure timely supply of bulk materials and supporting information to maintain a secure supply of reference materials, as well as managing GSK customer changes, risks, and issues related to outsourced services.

This role offers opportunities to lead key activities that will advance your career, including:

• Creating and deploying the GSC strategy for the robust supply of reference materials and critical reagents across the supply chain.
• Managing an internal team responsible for oversight of the reference material and reagent supply model.
• Working with GSK Quality & Compliance groups to ensure ongoing quality compliance.
• Assessing changes to reference material and reagent supply and coordinating regulatory support as needed.
• Implementing and maintaining QMS for the team and partners.
• Reviewing management monitoring and self-inspection schedules to ensure effectiveness.
• Supporting RCA and CAPA development for issues in supply of critical reference materials and reagents.
• Assessing non-GSK customer requirements.
• Acting as the primary contact for GSK customers, responding to queries, supporting audits, and providing data.
• Responding to regulatory and customer queries, reviewing regulatory dossiers.
• Ensuring team utilization of GSK systems and documentation.
• Supporting auditing of outsource partners and CROs.
• Managing relationships with outsource service providers and GSK sites.
• Identifying and implementing improvements to the outsource model.

Why you?

Basic Qualifications:

We are looking for professionals with these skills:

• Bachelor of Science degree in Chemistry
• 10+ years leading and executing projects in R&D or GSC QC/QA units
• 5+ years leadership experience
• 2+ years strategic execution experience
• 3+ years reference standard experience
• 5+ years analytical experience

Preferred Qualifications:

Additional desirable characteristics include:

• Expertise in quality attributes of dose forms and analytical technologies for reference materials
• Ability to influence senior stakeholders across divisions
• Deep understanding of product development and QbD principles
• Strong problem-solving skills for complex technical issues
• Extensive knowledge of regulatory compliance (e.g., FDA GMPs)
• Experience implementing new standards and processes
• Knowledge of regulatory processes for new registrations
• Understanding of reference materials and related quality processes
• Proven ability to drive innovation and transformational change

#LI-GSK

The annual base salary ranges from $151,800 to $253,000, depending on various factors including location, skills, experience, and education. Benefits include health care, retirement plans, paid holidays, and more. Visit GSK US Benefits Summary for details.

Why GSK?

Uniting science, technology, and talent to get ahead of disease together.

GSK is a global biopharma company focused on vaccines, medicines, and immunology. Our success depends on our people. We aim to create an inclusive environment where employees can thrive, grow, and contribute to our mission. Join us in our journey to get Ahead Together.

If you need accommodations to apply, contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or [phone] (outside US).

GSK is an Equal Opportunity Employer. We consider all qualified applicants without regard to race, color, religion, sex, parental status, national origin, age, disability, or other protected categories.