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Director Analytical Development Pharmaceutical Jobs

Spyglass Pharma

Director, Analytical Development

Irvine, CA · On-site

$225K - $250K/yr

We are seeking a Director of Analytical Development to join our team at SpyGlass Pharma. This role ... This individual will work closely with cross-functional teams including pharmaceutical development ...

Elektrofi

Director, Analytical Development

Boston, MA · On-site

$180K - $252K/yr

Join us as a Director, Analytical Development , and you'll be part of a culture that welcomes ... Strong understanding of cGMP, GLP, and regulatory expectations in a pharmaceutical development ...

Elektrofi Inc

Director, Analytical Development

Boston, MA · On-site

$180K - $252K/yr

Join us as a Director, Analytical Development , and you'll be part of a culture that welcomes ... Strong understanding of cGMP, GLP, and regulatory expectations in a pharmaceutical development ...

BridgeBio Pharma

Director, Analytical Development

... pharmaceutical/biotech industry. Demonstrated abilities in the development and application of ... analytical assay, impurity, and in-vitro (dissolution) release. Experience in high performance ...

BridgeBio Pharma

Director, Analytical Development

$144K - $159K/yr

... pharmaceutical/biotech industry. Demonstrated abilities in the development and application of ... analytical assay, impurity, and in-vitro (dissolution) release. Experience in high performance ...

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Director Analytical Development Pharmaceutical information

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How much do director analytical development pharmaceutical jobs pay per year?

As of Sep 11, 2026, the average yearly pay for director analytical development pharmaceutical 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 does a director of analytical development do in the pharmaceutical industry?

A Director of Analytical Development in the pharmaceutical industry oversees the development, validation, and implementation of analytical methods used to test drug products and substances. They lead teams that ensure the accuracy, reliability, and compliance of analytical data with regulatory standards. Their responsibilities include managing laboratory operations, supporting product development, ensuring quality control, and interacting with regulatory agencies. This role is crucial for bringing safe and effective drugs to market and maintaining high standards throughout the drug development process.

What are the key skills and qualifications needed to thrive as a director of analytical development in the pharmaceutical industry?

To thrive as a Director of Analytical Development in pharmaceuticals, you need advanced expertise in analytical chemistry, regulatory guidelines (such as ICH and FDA), and typically a Ph.D. in a relevant scientific discipline. Familiarity with analytical instrumentation (HPLC, GC, MS), laboratory information management systems (LIMS), and quality systems is crucial, along with experience in method development and validation. Exceptional leadership, project management, and communication skills help drive cross-functional collaboration and mentor diverse teams. These skills ensure robust analytical support for drug development, regulatory compliance, and timely delivery of high-quality pharmaceutical products.

What are some common challenges faced by a director of analytical development in the pharmaceutical industry?

A Director of Analytical Development often manages complex projects that require balancing regulatory compliance, tight timelines, and cross-functional collaboration. One common challenge is ensuring analytical methods are robust and validated to meet evolving regulatory standards while supporting multiple product development stages. Additionally, this role frequently involves leading and mentoring a diverse team of scientists, which requires strong leadership and communication skills. Successful directors stay proactive in problem-solving and keep teams aligned with organizational goals.

What is the difference between Director Analytical Development Pharmaceutical vs Analytical Development Scientist?

AspectDirector Analytical Development PharmaceuticalAnalytical Development Scientist
CredentialsBachelor's/Master's/PhD in Chemistry, Pharmaceutical Sciences, or related field; extensive experienceBachelor's or Master's in Chemistry, Pharmaceutical Sciences, or related field; entry to mid-level experience
Work EnvironmentLeadership role overseeing teams, strategic planning, and project management in pharmaceutical R&DHands-on laboratory work, method development, and testing in pharmaceutical labs
Employer & Industry UsageUsed in pharmaceutical companies, biotech firms, and contract research organizationsCommonly employed in similar settings, often reporting to senior staff

The main difference between a Director Analytical Development Pharmaceutical and an Analytical Development Scientist lies in their responsibilities and experience level. The director oversees teams, strategic planning, and project management, while the scientist focuses on laboratory work and method development. Both roles are essential in pharmaceutical R&D but differ significantly in scope and seniority.

What are popular job titles related to Director Analytical Development Pharmaceutical jobs?

For Director Analytical Development Pharmaceutical jobs, the most frequently searched job titles are:

Infographic showing various Director Analytical Development Pharmaceutical job openings in the United States as of September 2026, with employment types broken down into 100% Full Time. Highlights an 75% In-person, and 25% Remote job distribution, with an average salary of $191,412 per year, or $92 per hour.

Director, Analytical Development

Cambridge, MA • On-site

United Therapeutics Corporation
Pharmaceutical and Medicine Manufacturing • 501 - 1,000 employees
Learn more about United Therapeutics Corporationexternal

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 11 days ago

Job description

California, US residents click here.
The job details are as follows:
Who We Are
We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.
United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF).
The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option.
Thymmune, a United Therapeutics subsidiary is a biotechnology company developing a machine learning-driven thymic cell engineering platform to restore normal immune function in aging and disease. The company's cutting-edge approach in iPSC-thymic cell manufacturing can generate off-the-shelf cells at scale. The company is developing a pipeline of therapies to treat immunodeficiencies, transplant related, and autoimmune diseases.
Who You Are
Some people develop assays. Others help build the future of medicine. At Thymmune, you'll do both. As our Director of Analytical Development, you'll lead a high-performing team, shape analytical strategy for a pioneering cell therapy pipeline, and help advance technologies that could redefine how we treat immune disorders and expand the possibilities of transplant medicine. This is a rare opportunity to combine scientific leadership, innovation, and purpose in an environment where bold ideas are encouraged and meaningful impact is expected every day.
The Director, Analytical Development will be leading Thymmune's analytical development strategy to support Thymmune's iPSC derived cell therapy pipeline. This role will define and execute analytical development and method transfer activities to enable iPSC expansion and differentiation in GMP manufacturing throughout the product lifecycle.
  • Lead the strategy, priorities, and roadmap for analytical development and develop phase-appropriate and risk-based analytical assays and potency testing strategies to support Thymmune's pipeline of iPSC-derived cell therapy products
  • Recruit, manage, train, motivate, develop, and mentor Analytical Development staff
  • Provide leadership, direction, and resource allocation for analytical development activities to ensure achievement of departmental objectives and program milestones. Execute analytical development work and perform assays in a laboratory setting, as necessary
  • Oversee and perform the development, authoring, review, and approval of SOPs, test methods, method development reports, and supporting procedures for analytical method development and qualification in support of GMP manufacturing and QC testing
  • Act as an SME for analytical development and lead knowledge and technology transfer strategy and execution for in-process, release, and product characterization methods to CDMOs and CTLs
  • Provide strategic and technical leadership to resolve complex QC testing issues during clinical production at CDMOs. Provide person-in-plant support, as needed
  • Develop, review, and approve analytical development source documents, and provide oversight for relevant CMC sections for regulatory submissions. Support the Regulatory group in responding to agency questions and influence analytical strategies supporting regulatory submissions and agency interactions
  • Lead due diligence, evaluation, and selection activities for Contract Testing Labs (CTLs). Actively participate in due diligence exercise for CDMO selection
  • Ensure the team stays up to date with current technologies and trends, driving continuous improvement, operational excellence, and the advancement of analytical development capabilities
  • Support budget planning, resource forecasting, and capital requirement planning for the Analytical Development function, including developing business cases and recommendations to support departmental and organizational priorities
  • Establish and execute the strategic direction, priorities, and resource plans for the Analytical Development function, partnering cross-functionally with Regulatory, Quality, CDMOs, CTLs, and other R&D stakeholders to support organizational objectives and long-term departmental capabilities
  • Perform all other duties as assigned

Minimum Requirements
  • 15+ years of biotech/pharma industry experience preferably in cell and gene therapy with a Bachelor's Degree in biological sciences, immunology, cell biology, biomedical or biochemical engineering or 13+ years of biotech/pharma industry experience preferably in cell and gene therapy with a Master's Degree in biological sciences, immunology, cell biology, biomedical or biochemical engineering or 10+ years of biotech/pharma industry experience preferably in cell and gene therapy with a PhD in biological sciences, immunology, cell biology, biomedical or biochemical engineering
  • 7+ years of previous managerial experience
  • Technical expertise in cell therapy analytical methods, such as potency assays, flow cytometry-based assays, and product characterization assays
  • Experience in analytical method development, optimization, qualification, and transfer, in accordance with regulatory guidelines and industry standards
  • Hands-on experience in the characterization of cell therapy products using methods such as flow cytometry, RT-PCR, and ddPCR
  • Knowledge of safety assays required for lot release such as endotoxin, mycoplasma, and sterility, including rapid release tests
  • Expertise in analytical control strategies including specification setting
  • Experience in setting and managing stability studies per ICH guidelines and establishing shelf life for drug substance and drug product
  • Experience with cell-based potency assay development and defining potency testing strategy for cell therapy products
  • Experience establishing and managing interactions with CDMOs and CTLs
  • In-depth understanding of regulatory guidelines and experience with CMC regulatory filings
  • Excellent analytical and problem-solving skills, with a strong ability to troubleshoot critical issues or problems
  • Excellent communication, technical writing, and presentation skills
  • Ability to work hands-on with a high sense of urgency, accountability, and focus on delivering results
  • Exceptional teamwork and interpersonal skills with the ability to motivate others, influence, and negotiate difficult situations
  • Strong attention to detail and demonstrated ability to collaborate effectively on cross-functional teams and within a dynamic environment

Preferred Qualifications
  • Doctor of Philosophy (PhD) in biological sciences, immunology, cell biology, biomedical or biochemical engineering or Master's Degree in biological sciences, immunology, cell biology, biomedical or biochemical engineering
  • Knowledge and experience in developing and qualifying analytical methods for iPSC derived cell therapy products
  • Experience with whole genome sequencing methodologies, bioinformatics pipeline, and scRNA Seq

The salary range for this position is $185,000.00 - $240,000.00 and reflects our good-faith estimate of the compensation for this role at the time of posting. An employee's position within the salary range will be based on factors such as education, qualifications, experience, skills, geographic location, and business needs, as well as other factors permitted by law at the time of posting. This range may be modified in the future based on company and market factors.
Location
This role is based in our Cambridge, MA Thymmune location.
Eligible employees may participate in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities
United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.

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