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Director Analytical Assay Development Jobs (NOW HIRING)

Rocket Pharmaceuticals

NJ · On-site

$250/hr

Position Summary Rocket Pharma is seeking an experienced Senior Director, Analytical Development to ... Proven experience developing assays to support cell and gene therapy programs in both development ...

Quanterix

Sr. Director, Assay Development

Billerica, MA · On-site

$225K - $265K/yr

We are seeking an experienced and highly motivated Sr. Director, Assay Development to drive ... analysis, interpretation, and reporting techniques and tools. * Write, review and/or approve ...

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Director Analytical Assay Development information

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$89K

$191.4K

$287.5K

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

As of Sep 9, 2026, the average yearly pay for director analytical assay 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 does a director analytical assay development do?

A Director of Analytical Assay Development oversees the design, development, and implementation of laboratory assays used to analyze biological samples, usually in pharmaceutical, biotech, or diagnostic companies. They lead teams to ensure assays are robust, reproducible, and meet regulatory requirements for drug development or product release. Their responsibilities also include strategic planning, managing resources, collaborating with cross-functional teams, and ensuring compliance with industry standards and guidelines.

How does a director analytical assay development collaborate with cross-functional teams to ensure project success?

A Director of Analytical Assay Development works closely with teams such as Research & Development, Quality Assurance, Regulatory Affairs, and Manufacturing. They facilitate communication to align assay development with project milestones, regulatory requirements, and production timelines. By coordinating activities and sharing technical expertise, the director ensures assays meet both scientific and compliance standards. This collaboration is essential for smooth project progression and the successful launch of new products.

What are the key skills and qualifications needed to thrive as a director analytical assay development, and why are they important?

To thrive as a Director of Analytical Assay Development, you need an advanced degree in chemistry, biochemistry, or a related field, with deep expertise in assay design, validation, and regulatory requirements. Familiarity with analytical instrumentation (such as HPLC, LC-MS, and ELISA), method development software, and relevant industry certifications (e.g., GLP/GMP) is essential. Strong leadership, project management, and cross-functional communication skills distinguish top performers in this role. These competencies are critical for ensuring robust assay development, regulatory compliance, and successful collaboration across scientific teams.

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

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

Director, Analytical Development

Cambridge, MA • On-site

Scorpion Therapeutics
51 - 200 employees
Learn more about Scorpion Therapeuticsexternal

$200 - $250/hr

Other

Medical, Dental, Vision, Retirement, PTO

Posted 4 days ago

Job description

Responsibilities:
  • Lead analytical development strategy, priorities, roadmap; develop phase-appropriate, risk-based analytical assays and potency testing for iPSC-derived cell therapy products.
  • Recruit/manage/train/mentor Analytical Development staff.
  • Lead analytical development and method transfer to support iPSC expansion/differentiation in GMP manufacturing across the product lifecycle.
  • Oversee development/authoring/review/approval of SOPs, test methods, and qualification documentation supporting GMP and QC.
  • Act as SME for analytical development; lead technology transfer (in-process, release, product characterization) to CDMOs and CTLs.
  • Resolve complex QC testing issues during clinical production at CDMOs (person-in-plant support as needed).
  • Develop/review/approve analytical development source documents; provide CMC oversight for regulatory submissions; support regulatory responses and influence analytical strategy.
  • Lead CTL due diligence, evaluation, and selection; support CDMO selection due diligence.
  • Drive continuous improvement; support budget/resource/capital planning.
  • Partner cross-functionally (Regulatory, Quality, CDMOs, CTLs, R&D) and perform other assigned duties.
Minimum requirements:
  • 15+ years (BS) OR 13+ years (MS) OR 10+ years (PhD) biotech/pharma experience in cell/gene therapy; 7+ years managerial experience.
  • Expertise in cell therapy analytical methods (potency assays, flow cytometry-based assays, product characterization); method development/optimization/qualification/transfer.
  • Hands-on characterization (flow cytometry, RT-PCR, ddPCR); safety assays for lot release (endotoxin, mycoplasma, sterility, rapid release).
  • Analytical control strategies/specifications; stability studies per ICH and shelf-life setting.
  • Potency assay development/strategy for cell therapy; experience with CDMOs/CTLs.
  • Regulatory/CMC filings experience; strong analytical/problem-solving, communication/technical writing/presentation, urgency/accountability, teamwork, and cross-functional collaboration.
Preferred qualifications:
  • PhD/MS in relevant fields; iPSC-derived analytical method development/qualification experience.
  • Whole genome sequencing, bioinformatics pipeline, scRNA-seq experience.
Compensation/benefits:
  • Salary range: $185,000-$240,000.
  • Comprehensive benefits (medical/dental/vision/prescription, wellness resources, 401k/ESPP, paid time off & paid parental leave, disability, etc.).
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