Associate Director, Analytical Development

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Oversee the preparation, evaluation, and authorization of analytical reports, data summaries, protocols, specifications, methods, and other CMC technical documentation.

• Assess analytical data packages that support release testing, stability studies, drug substance, intermediates, and drug product manufacturing processes.

• Collaborate closely with Regulatory CMC, Quality, and external CDMOs to ensure the prompt delivery of analytical documentation and reports.

• Assist in the development, validation, qualification, transfer, and lifecycle management of analytical methods across both development and commercial programs.

• Draft, review, and manage technical documents including analytical methods, validation protocols and reports, specifications, trend reports, and regulatory submission documents.

• Coordinate analytical reporting activities for drug substance and drug product stability programs, ensuring accurate documentation and communication of data.

• Aid in the preparation and evaluation of CMC sections for regulatory submissions, responses to health authorities, and other regulatory filings.

• Engage in analytical investigations concerning deviations, OOS, OOT, and laboratory events, ensuring that documentation complies with quality and regulatory standards.

• Work with external laboratories and CDMOs to guarantee that analytical deliverables are scientifically sound, compliant, and synchronized with program timelines.

• Lead continuous improvement initiatives aimed at enhancing analytical reporting processes, data integrity, document quality, and operational efficiency.

⛳️ Requirements

• PhD in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or a related scientific field with 8+ years of pertinent industry experience, OR a Master's degree with 10+ years of experience, OR a Bachelor's degree with 12+ years of experience.

• Background in analytical development, analytical reporting, CMC technical writing, or related pharmaceutical development roles.

• Robust understanding of small molecule analytical development, method validation, method transfer, stability testing, specifications, and control strategies.

• Proven experience in authoring, reviewing, and approving technical documents such as analytical methods, protocols, reports, and regulatory-supporting documentation.

• Experience in evaluating analytical data produced by CDMOs, CROs, and external testing laboratories.

• Proficient knowledge of analytical techniques including HPLC/UPLC, GC, dissolution, spectroscopy, mass spectrometry, wet chemistry, particle size analysis, and other pharmaceutical characterization methods.

• Acquainted with ICH, FDA, EMA, and other global regulatory standards pertinent to analytical development and CMC documentation.

• Strong skills in scientific writing, data interpretation, problem-solving, and project management.

• Exceptional verbal and written communication abilities, capable of conveying complex technical information to diverse audiences effectively.

• Demonstrated capability to work efficiently within a cross-functional matrix organization and to foster strong relationships with internal stakeholders and external partners.

• Highly organized with the aptitude to manage multiple priorities in a dynamic biotech environment.

🏝️ Benefits

• 100% coverage of medical, dental, and vision premiums for you and your family.

• Funding for up to 75% of in-network deductibles.

• 401(k) matching with immediate vesting.

• Generous paid time off.

• 12 weeks of fully paid parental leave.

• Paid family and medical leave for all employees.

• Company-paid short-term disability coverage for up to 20 weeks.

• Wellness programs.

• Tuition reimbursement.

• Support for inclusive family-forming.