Method Development Lead

Posted 11 Days Ago
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Harrogate, North Yorkshire, England, GBR
In-Office
Senior level
Pharmaceutical
The Role
Lead and deliver analytical method development and validation (LC-MS/MS, GC) for environmental matrices under GLP and non-GLP. Manage a small technical team, act as Study Director/contributing scientist, engage with clients, interpret complex data, produce regulatory-ready reports, support audits/inspections, and drive continuous improvement and emerging contaminant strategies.
Summary Generated by Built In

An exciting opportunity has arisen for a Method Development Lead to join the Chemistry department within the Environmental Risk Sciences (ERS) division of Smithers, based in Harrogate.

This role is ideal for an experienced analytical scientist with a strong background in method development and validation, particularly for pharmaceuticals, veterinary medicines, agrochemicals, and biocides, who is looking to play a key role in shaping the technical and scientific direction of a growing team.

Smithers ERS Limited provides environmental and regulatory safety testing services to clients across the pharmaceutical, agricultural, chemical, and biocidal sectors. Our analytical teams support regulatory submissions by generating high-quality, defensible data in compliance with international guidelines and quality systems.

The Role

Reporting to the Director of Chemistry, the Method Development Lead will manage and deliver complex analytical method development activities, lead a small team of technical specialists supporting both routine and novel studies. The role includes a mix of hands-on laboratory work, GLP Study Director responsibilities, and client-facing scientific interaction, making it well suited to a technically strong scientist with good communication skills and regulatory awareness.

The successful candidate will contribute to the development of analytical strategies for emerging contaminants, supporting environmental exposure, fate, and risk assessment studies under GLP and non-GLP frameworks.

Key Responsibilities

  • Design, develop, optimise, and validate analytical methods for target molecule within complex environmental relevant matrices
  • Apply advanced analytical techniques, with a strong focus on LC-MS/MS and GC-based methods
  • Act as a Contributing Scientist for assigned analytical and environmental chemistry studies
  • Lead a small technical team of 3 members facilitating scheduling, method triage and technical support
  • Provide technical leadership and scientific input into study design and method strategy
  • Support the identification and assessment of emerging environmental contaminants
  • Interpret complex analytical data and produce high-quality, regulator-ready reports
  • Engage directly with clients to discuss technical approaches, troubleshoot challenges, and support study delivery
  • Contribute to continuous improvement, innovation, and best practice within the analytical team
  • Support audits, inspections, and regulatory interactions as required

Qualifications and Experience

  • BSc, MSc or PhD in Chemistry, Analytical Chemistry, Environmental Chemistry, or a related discipline
  • Significant practical experience in analytical method development within a regulated laboratory or CRO environment
  • Strong hands-on expertise with LC-MS/MS and GC instrumentation
  • Experience working with pharmaceuticals, veterinary medicines, agrochemicals, and/or biocidal products
  • Demonstrated understanding of emerging contaminants in the environment and their analytical challenges
  • Experience acting as a Study Director or supporting study direction under GLP is highly desirable
  • Strong problem-solving ability, attention to detail, and scientific judgement
  • Excellent communication, organisational, and client-facing skills

We Offer

We offer the opportunity to work on diverse and technically challenging projects alongside experienced scientists, while developing a rewarding and flexible career. Our benefits include:

  • Private Medical Insurance with Bupa
  • Employer-matched pension contributions
  • Eyecare vouchers
  • Ride to Work scheme
  • Life assurance cover
  • Employee Assistance Programme
  • Free mortgage advice service

Join Smithers and help shape the future of environmental and analytical science.

#Smithers #AnalyticalChemistry #EnvironmentalChemist #LCMS #GCMS #EmergingContaminants #GLP #RegulatoryScience


Skills Required

  • BSc, MSc or PhD in Chemistry, Analytical Chemistry, Environmental Chemistry, or related discipline
  • Significant practical experience in analytical method development within a regulated laboratory or CRO environment
  • Strong hands-on expertise with LC-MS/MS instrumentation
  • Strong hands-on expertise with GC instrumentation
  • Experience working with pharmaceuticals, veterinary medicines, agrochemicals, and/or biocidal products
  • Demonstrated understanding of emerging environmental contaminants and associated analytical challenges
  • Experience acting as a Study Director or supporting study direction under GLP
  • Strong problem-solving ability, attention to detail, and scientific judgement
  • Excellent communication, organisational, and client-facing skills
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The Company
HQ: Akron, OH
783 Employees
Year Founded: 2005

What We Do

Our team helps medical device and pharmaceutical product manufacturers bring innovative, compliant and highly effective products to market with world-class expertise and extensive, independent testing capabilities at accredited facilities in the UK and USA. Our experienced medical device and extractables and leachables (E&L) testing teams will provide advice, guidance and recommendations as well as delivering test data to help you demonstrate compliance to regulatory guidance or specifications set out by the FDA, EMA, MHRA, USP, ASTM and ISO. Smithers also supports the pharmaceutical industry and the development of biologics and vaccines from discovery through phase IV, with expertise that includes bioassays and high sensitivity assays. Our scientists have expertise in large molecule bioanalysis assay development, validation, and sample analysis.

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