Associate Director, Analytical Development

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🕒 Julho 30

🍂 Massachusetts – Remoto

🍂 Massachusetts – Remote

💵 $180.000 - $210.000 / ano

⏰ Tempo Integral

🟠 Sênior

👔 Diretor

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CultureHQ

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1 - 10 funcionários

Fundada em 2017

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Descrição

• 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.

🎯 Requisitos

• 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.

🏖️ Benefícios

• 100% medical, dental, and vision premiums covered for you and your family • Up to 75% of in-network deductibles funded • 401(k) match 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 • Inclusive family-forming support