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Analytical Method Development Jobs (NOW HIRING)

Astrix Inc

Quality Analytical Chemist

Cincinnati, OH · On-site

$28 - $31/hr

This is an excellent opportunity for an analytical chemist with strong instrumentation experience who enjoys method development, troubleshooting, training, and collaborating across quality ...

Eurofins

Bioassay Method Development

Indianapolis, IN · On-site

... Development and Manufacturing Organisations. It also has a rapidly developing presence in highly ... Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety ...

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Analytical Method Development information

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$89K

$191.4K

$287.5K

How much do analytical method development jobs pay per year?

As of Jul 9, 2026, the average yearly pay for analytical method development in the United States is $191,412.00, according to ZipRecruiter salary data. Most workers in this role earn between $94,000.00 and $249,000.00 per year, depending on experience, location, and employer.

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

To excel in Analytical Method Development, a strong background in chemistry, analytical techniques, and statistical analysis is typically required, often supported by a relevant science degree. Familiarity with laboratory instrumentation such as HPLC, GC, MS, and validation protocols, as well as experience with software like Empower or ChemStation, is highly valued. Attention to detail, problem-solving, and effective communication are crucial soft skills for this role. These competencies are vital to ensure robust method development, regulatory compliance, and effective teamwork in a laboratory setting.

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

A typical day involves designing, executing, and optimizing analytical experiments to develop new testing methods or improve existing ones, often using advanced laboratory instruments. You may also analyze data, document results, troubleshoot instrument or methodological issues, and collaborate with scientists, quality assurance, and production teams. Regular tasks include preparing reports for regulatory submissions, participating in team meetings to discuss progress and challenges, and maintaining rigorous documentation standards. The role balances independent technical work with teamwork and cross-departmental communication to ensure methods meet performance, accuracy, and compliance standards.

What is an Analytical Method Development job?

An Analytical Method Development job involves designing, optimizing, and validating methods for analyzing pharmaceutical, chemical, or biological samples. Professionals in this role ensure accurate, reliable, and reproducible results by developing techniques like chromatography, spectroscopy, or titration. They collaborate with research, quality control, and regulatory teams to comply with industry standards and guidelines. This role is critical in drug development, manufacturing, and ensuring product quality and safety.

More about Analytical Method Development jobs
What are the most commonly searched types of Analytical Method Development jobs? The most popular types of Analytical Method Development jobs are:
What states have the most Analytical Method Development jobs? States with the most job openings for Analytical Method Development jobs include:
Analytical Method Development jobs near you
Senior Manager, Analytical Development

Senior Manager, Analytical Development

Harmony Biosciences

Plymouth Meeting, PA • On-site

Other

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 8 days ago

Job description

Harmony Biosciences is recruiting for a Senior Manager, Analytical Development in our Plymouth Meeting Office. This position is a key contributor within Harmony's Technical Operations organization, supporting the analytical development and oversight of drug substance and drug product activities across external manufacturing partners. The individual in this position will play an integral role in coordinating and executing analytical strategies for both clinical and commercial programs, ensuring continuity of supply and adherence to the highest quality standards. Working cross-functionally, this role helps drive the delivery of safe, reliable, and high-quality pharmaceutical products to patients by enabling seamless execution of analytical activities across the development lifecycle.



Responsibilities include but are not limited to:

  • Serve as an analytical Subject Matter Expert (SME) for clinical and development programs, including drug substance and drug product (oral solids/liquids and other dosage forms) development and manufacturing at contractor sites
  • Lead and support analytical development activities at multiple contractor sites related to analytical method development, method improvements, product characterization and comparability assessments for Harmony's early and late-stage programs
  • Direct technical oversight of multiple Contract Organizations (COs), with the following responsibilities:
  • Serve as technical resource on drug substance and drug product aspects with particular emphasis in analytical chemistry and associated methodologies
  • Provide oversight and serve as technical lead for the execution of method development, method improvement and method validation activities
  • Manage laboratory deviations/investigations to successful closure in a timely manner as product SME in close and seamless collaboration with Harmony's Quality function
  • Oversee and co-manage release testing and stability programs for drug substance and drug product with Quality Assurance
  • Ensure COs meet Harmony business objectives while meeting quality and compliance standards
  • Drive uncompromising quality as a fundamental and valued attribute of all output and patient safety as an overarching responsibility
  • Review and maintain lifecycle product documentation and data files related to analytical activities for early and late-stage development programs, including but not limited to protocols, reports, SOPs, certificates, etc.
  • Work closely with the Project Manager and Contract Organizations (CMOs/CROs) to ensure all analytical deliverables are aligned and meet agreed project timelines. Apply Quality by Design (QBD) principles and Design of Experiments (DoE) to develop robust analytical methods.
  • Trend, analyze, and statistically interpret stability data.
  • Identify degradation pathways and variability drivers.
  • Establish scientifically justified shelf-life projections.
  • Collaborate with other Harmony departments as required to:
    • Achieve corporate goals and mission for uninterrupted clinical and commercial supply to patients
    • Work closely with teams to define analytical testing strategy
    • Develop and maintain technical aspects of quality agreements
    • Implement analytical improvement or analytical aspects of other product lifecycle programs
    • Lead the execution of analytical technology transfers, method implementation, qualification/validation
    • Prepare and review dossiers for regulatory filings
    • Drive fiscal responsibility with the operational budget and cost savings initiatives



Qualifications:

  • Bachelor's degree in in Analytical Chemistry (or related field) with 8+ years of relevant industry experience; Master's degree with 5+ years of relevant industry experience; or PhD with 2+ years of relevant industry experience.
  • Technical Proficiency in analytical method development, including dissolution testing, chromatographic techniques (such as HPLC, and GC), and spectroscopy methods (such as UV-Vis, NMF, MS, along with expertise in method robustness and qualification/validation requirements. Experience managing a contract manufacturing organization (CMO) is a plus.
  • Knowledge and application of pharmaceutical analytical development principles, concepts, and industry practices to assist during audits or vendor inspections, and offer solutions to troubleshoot technical problems
  • Experience in developing and transferring analytical methods from R&D to the commercial stage of the product lifecycle
  • Knowledge of regulatory environment (FDA/ICH regulations) and experience with organizing and writing regulatory submissions
  • Knowledge and demonstrated mastery of current Good Manufacturing Practices (cGMPs) and associated quality guidance and principles (ICH, USP, and ISO standards), with particular emphasis on laboratory techniques and procedures
  • Strong computer, organizational, and analytical skills required

Physical demands and work environment:

  • Travel (both domestic and international) is estimated to be 20% of the time for this position; Candidate must be able to maintain or obtain valid US Passport within 90 days of hire date
  • While performing the duties of this job, the noise level in the work environment is usually quiet.
  • Specific vision abilities required by this job include: Close vision.
  • Manual dexterity required to use computers, tablets, and cell phone.
  • The employee must occasionally lift and /or move more than 20 pounds.
  • Continuous sitting for prolonged periods.



What can Harmony offer you?

  • Medical, Vision and Dental benefits the first of the month following start date
  • Generous paid time off and Company designated Holidays
  • Company paid Disability benefits and Life Insurance coverage
  • 401(k) Retirement Savings Plan
  • Paid Parental leave
  • Employee Stock Purchase Plan (ESPP)
  • Company sponsored wellness programs
  • Professional development initiatives and continuous learning opportunities
  • A certified Great Place to Work for eight consecutive years based on our positive, values-based company culture

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Harmony Biosciences is a pharmaceutical company headquartered in Plymouth Meeting, PA. The company was established in October 2017 with a vision to provide novel treatment options for people living with rare, neurological disorders who have unmet medical needs. For more information on Harmony Biosciences, visit www.harmonybiosciences.com


Harmony Biosciences is an Equal Opportunity, e-Verify Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Recruitment agencies please note: Harmony Biosciences will only accept applications from agencies/business partners that have been invited to work on a specific role. Candidate Resumes/CV's submitted without permission or directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation.



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