Associate Director – Drug Substance Manufacturing & Development

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October 23

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CultureHQ

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SaaS

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1 - 10 employees

Founded 2017

☁️ SaaS

📋 Description

• 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.

🎯 Requirements

• 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. Familiar with ICH guidelines as they relate to these controls. • 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. The ability to lead polymorph, salt/co-crystal evaluation, and selection. Familiar with the use of XRPD, DSC, TGA, DVS, PSD, and microscopy to support characterization. • Ability to collaborate with diverse stakeholders, both internally and external contract manufacturers. • Detail oriented with strong written and oral communication skills and proven history of working with others in a multidisciplinary team environment. • Ability to troubleshoot problems, work within a team. • Ability to manage multiple projects simultaneously, creative in developing strategies for solving problems, and is driven by project requirements such as milestones and timelines. • Ability to travel internationally and within the USA up to 10 – 30%, as required, to meet project objectives.

🏖️ Benefits

• Competitive pay • Performance-based bonus • Stock options • Insurance coverage (health, dental, life, and disability) • Competitive time-off • 401(k) plan • Commuter/parking benefits