Associate Director, Analytical Development

• Lead the preparation, review, and approval of analytical reports, data summaries, protocols, specifications, methods, and other CMC technical documentation.
• Review analytical data packages supporting release testing, stability studies, drug substance, intermediates, and drug product manufacturing activities.
• Partner closely with Regulatory CMC, Quality, and external CDMOs to ensure timely delivery of analytical documentation and reports.
• Support analytical method development, validation, qualification, transfer, and lifecycle management activities across development and commercial programs.
• Author, review, and manage technical documents including analytical methods, validation protocols and reports, specifications, trend reports, and regulatory submission documentation.
• Coordinate analytical reporting activities for drug substance and drug product stability programs and ensure data are accurately documented and communicated.
• Support the preparation and review of CMC sections for regulatory submissions, responses to health authorities, and other regulatory filings.
• Participate in analytical investigations related to deviations, OOS, OOT, and laboratory events, ensuring documentation meets quality and regulatory expectations.
• Collaborate with external laboratories and CDMOs to ensure analytical deliverables are scientifically sound, compliant, and aligned with program timelines.
• Drive continuous improvement initiatives focused on analytical reporting processes, data integrity, document quality, and operational efficiency.

Qualifications:

• • PhD in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or a related scientific discipline with 8+ years of relevant industry experience, OR Master's degree with 10+ years of experience, OR Bachelor's degree with 12+ years of experience.
  • Experience in analytical development, analytical reporting, CMC technical writing, or related pharmaceutical development functions.
  • Strong understanding of small molecule analytical development, method validation, method transfer, stability testing, specifications, and control strategies.
  • Demonstrated experience authoring, reviewing, and approving technical documents including analytical methods, protocols, reports, and regulatory-supporting documentation.
  • Experience reviewing analytical data generated by CDMOs, CROs, and external testing laboratories.
  • Working knowledge of analytical techniques such as HPLC/UPLC, GC, dissolution, spectroscopy, mass spectrometry, wet chemistry, particle size analysis, and related pharmaceutical characterization methods.
  • Familiarity with ICH, FDA, EMA, and other global regulatory requirements related to analytical development and CMC documentation.
  • Strong scientific writing, data interpretation, problem-solving, and project management skills.
  • Excellent verbal and written communication skills with the ability to effectively communicate complex technical information to diverse audiences.
  • Proven ability to work effectively within a cross-functional matrix organization and build strong relationships with internal stakeholders and external partners.
  • Highly organized with the ability to manage multiple priorities in a fast-paced biotech environment.

  Preferred Qualifications

  • Experience supporting late-stage development or commercial programs.
  • Experience contributing to IND, NDA, MAA, or other global regulatory submissions.

Salary Range:

$185,000 - 215,000 USD