Director, Drug Substance Manufacturing – Development

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🕒 Julho 16

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Descrição

• Subject matter expert for all aspects of drug substance process and controls. • Manage development and manufacturing activities at drug substance CDMOs. • Lead small molecule drug substance route selection/evaluation, scale up, and process control development including identification of critical process parameters, critical quality attributes, and acceptance criteria. • Review and approve external vendor documentation including protocols, reports, raw data, master and executed batch records. • Perform impurities fate analysis and manufacturing process parameters assessment and develop an overall end-to-end control strategy. • Lead solid state evaluation and development activities to support process control, formulation development, and intellectual property protection. • Provide drug substance support for quality events including deviation investigation, corrective and preventative action implementation and change control for both internal and external operations. • Author, review, and approve documents in support of regulatory filings including module 3 sections of Investigational New Drug (IND) applications and New Drug Application (NDA) as well as CMC section in a global regulatory submission. • Provide guidance as a subject matter expert in drug substance manufacturing and development for internal CMC and discovery organization. • Provide on-site support at external suppliers including project initiation, routine visits and technical leadership as needed.

🎯 Requisitos

• Degree in Organic chemistry - Bachelor’s/Master’s degree with 12+ years of experience or PhD degree with 8+ years of experience. • Subject matter expert in small molecule drug substance production techniques, processing, and characterization and have a demonstrated track record of successful CDMO management. • Extensive experience in small molecule cGMP manufacturing and proficient knowledge of ICH Q7 guidelines. • Experience in evaluating and setting phase appropriate controls including raw material, in-process, intermediate, and final drug substance specifications. • History writing, reviewing and approving quality documents (batch records, SOPs, change controls) and participating in quality events (deviation investigation, CAPA, audits). • Experience writing, reviewing and approving technical documents including development reports, risk assessments, and regulatory drug substance sections (IND, IMPD,NDA). • Working knowledge of solid-state development and characterization, ability to lead polymorph, salt/co-crystal evaluation, and selection. • Ability to collaborate with diverse stakeholders, both internally and external contract manufacturers. • Detail oriented, strong written and oral communication skills, and proven history of working with others in a multidisciplinary team environment. • Ability to manage multiple projects simultaneously and creative in developing strategies for solving problems. • Ability to travel internationally and within the USA up to 10 – 30%, as required.

🏖️ Benefícios

• 100% coverage of medical, dental, and vision premiums for employees and families • Funding up to 75% of in-network deductibles • 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