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Analytical Method Validation Jobs (NOW HIRING)

Actalent

Scientist - Analytical

Cumnock, NC · On-site

Draft method validation protocols and reports, execute validation assays, and perform comprehensive data analysis in alignment with cGMP and data integrity principles. * Collaborate with colleagues ...

Apply Early

Actalent

Scientist - Analytical

Cumnock, NC

Draft method validation protocols and reports, execute validation assays, and perform comprehensive data analysis in alignment with cGMP and data integrity principles. * Collaborate with colleagues ...

Apply Early

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Analytical Method Validation information

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How much do analytical method validation jobs pay per hour?

As of Jul 4, 2026, the average hourly pay for analytical method validation in the United States is $52.00, according to ZipRecruiter salary data. Most workers in this role earn between $39.42 and $63.22 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive in the Analytical Method Validation position, and why are they important?

To thrive in Analytical Method Validation, you need a strong background in analytical chemistry or related sciences, precision in laboratory work, and experience with method development and validation protocols, often supported by a relevant degree. Familiarity with instrumentation such as HPLC, GC, and mass spectrometry, as well as knowledge of regulatory standards like ICH, FDA, or USP, and proficiency in laboratory information management systems (LIMS) are key. Attention to detail, critical thinking, and effective communication are important soft skills for troubleshooting and collaborating with cross-functional teams. These skills ensure robust, compliant analytical methods that underpin product quality and regulatory approval.

What is an Analytical Method Validation job?

An Analytical Method Validation job involves developing, assessing, and documenting laboratory methods to ensure they produce reliable and accurate results. Professionals in this role validate methods according to regulatory guidelines (such as ICH, USP, or FDA) by evaluating parameters like accuracy, precision, specificity, and robustness. They work in industries like pharmaceuticals, biotechnology, and chemicals to ensure compliance with quality standards. The role also requires troubleshooting analytical issues and maintaining validation records to support regulatory audits.

What does a typical day look like for someone working in Analytical Method Validation?

A typical day in Analytical Method Validation involves developing and executing protocols to verify that laboratory methods are reliable, accurate, and consistent with industry regulations. You'll spend time in the lab conducting experiments, analyzing sample data, documenting results, and preparing detailed validation reports for regulatory submission. Collaborating with quality assurance, regulatory teams, and other scientists is common to address findings and ensure alignment with project goals. This role combines hands-on technical work with critical data review and cross-disciplinary teamwork, offering a dynamic and intellectually engaging work environment.

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Analytical Method Validation jobs near you
Infographic showing various Analytical Method Validation job openings in the United States as of June 2026, with employment types broken down into 2% Internship, 84% Full Time, 7% Part Time, and 7% Contract. Highlights an 88% Physical, 4% Hybrid, and 8% Remote job distribution, with an average salary of $108,152 per year, or $52 per hour.

Associate Director-Analytical Method Validation & Transfer

Glenmark Pharmaceuticals

Monroe, NC • On-site

Full-time

Posted 18 days ago

Job description

POSITION SUMMARY
The Associate Director AMV is the analytical method validation lead & works with the Head Analytical Research (Formulations)/Head Global Analytical Validations based in India. The AMV lead at Monroe will liaison with injection development teams in India and oversee successful method validation at Monroe site. The Associate Director is responsible to provide analytical support for ANDA filings and regulatory deficiency response. The position also supports analytical method validation lifecycle management.
Project Coordinator Duties and Responsibilities:
  • Lead and manage the team carrying out the analytical validation for all methods of API, Excipients and Finished products.
  • Approve validation protocols, reports, SOPs related to validation and method change justifications.
  • Lead and manage invitro studies at site as per requirements.
  • Lead and manage the analytical method technology transfer of API, Excipients and Finished products to QC (Both in house and from third party CTLs).
  • Coordinate and collaborate with QC during Exhibit batch analysis and stability analysis.
  • Collaborate with Analytical R&D, QA, Manufacturing, Tech Transfer, and Regulatory Affairs.
  • Provide technical guidance during investigations, OOS/OOT, and CAPA implementation.
  • Submission of analytical documents to Regulatory affairs for filing purpose.
  • Respond to regulatory queries, FDA deficiencies, and observations related to analytical methods.
  • Lead and manage the life cycle management for analytical methods for API and Finished Products.
  • Coordinate with CMOs for analytical work and help them to do troubleshooting.
  • Act as a subject matter expert (SME) for analytical validation during regulatory inspections and audits.
  • Expected to support Pillar, Argentina and Osasco Brazil for analytical validation related activities

JOB RESPONSIBILITIES
Responsibilities
Manage the AMV team at Monroe to achieve the ANDA filings as per the project GRID
Collaborate with RA and Global PM teams to plan and execute experiments, provide justification/write-up for regulatory queries related to ANDA filing
Collaborate with CMO/CTL for successful execution analytical activities in support of ANDAs
Collaborate with quality team at Monroe for successful execution of ANDAs
Any other activities as assigned
KNOWLEDGE, SKILLS AND ABILITIES
Education
Minimum MS/Ph D in Pharmaceutical Sciences, Analytical Chemistry, or equivalent
Experience
18 + years in the Pharmaceutical Industry
Knowledge and Skills (Functional / Technical)
  • Chromatography
  • Wet chemistry
  • Injectable products in general
  • In Vitro studies
  • US FDA guidance related to analytical development, validation, specifications and
  • Knowledge of instrumentation like HPLC, GC, Malvern PSD, Zetasizer, UHPLC etc.
  • Sameness Studies

Leadership / Managerial Attributes
  • Able to manage a team of 4-6 direct reports
  • Able to deal with multiple locations

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