Associate Director Chemical Development

Associate Director Chemical Development

Requirements

• PhD in synthetic organic chemistry or a related field
• Targeting 8 years of experience in pharmaceutical research, development and manufacturing
• 2 years’ experience in a leadership role preferably in process development, process characterization, process validation, drug substance manufacturing and/or product life cycle management
• Leadership experience in managing diverse project activities with contract CDMO facilities at different global locations
• Experience with global pharmaceutical/chemical development and manufacturing operations for development-stage small molecules
• Highly knowledgeable with FDA and ICH guidelines relating to registration, quality and compliance with small molecule drug substance
• Strong understanding of organic synthetic chemistry concepts and cross-functional understanding related to API development and manufacturing from pre-IND through NDA
• Chemistry Manufacturing Controls (CMC) expertise to prepare documents for regulatory filing (e.g. IND to NDA)
• Extensive knowledge of current Good Manufacturing Practices (cGMPs)
• Excellent communication, interpersonal and presentation skills
• Ability to effectively collaborate with and direct the work of others on assigned projects
• Skilled at negotiating with business partners/management and influencing senior level leaders regarding matters of significance to the organization
• Demonstrated problem-solving abilities and conflict resolution skills
• Proficient at creating and communicating a clear vision among team members effectively aligning resources and activities to achieve functional area and/or organizational goals

Responsibilities

• Provide strong scientific support to the overall chemical development team
• Oversee contract development organizations to lead the development and optimization of drug substance processes
• Perform risk assessments of manufacturing process scale-up and use Quality by Design (QbD) principles
• Formulate drug substance development strategy to ensure product quality and facilitate regulatory approvals
• Facilitate technology transfer, chemical outsourcing, external manufacturing to deliver a robust supply chain
• Foster an inclusive workplace, creating staff development opportunities and encouraging innovation
• Engage in all facets of development from small scale synthesis to the development of the commercial synthetic route
• Develop and implement strategic and operational plans to deliver drug substance for multiple development projects
• Initiate, evaluate and validate new drug substance CSPs (Contract Service Providers)
• Establish and maintain good working relationships with contract service providers
• Work with CSPs to diagnose and correct process issues
• Work with Quality function to determine the impact of process deviations
• Develop timelines, goals, and deliverables for drug substances and related manufacturing processes
• Optimize the manufacturing process to maintain high product quality and improve process efficiency
• Ensure the supply of drug substance is consistent with development plans
• Ensure CSPs remain current and compliant with all cGMP related requirements
• Track deviations and processes changes for the different suppliers
• Initiate and coordinate the preparation of CMC documentation
• Collaborate with Regulatory Affairs and other groups to support product filings
• Assist in contract site preparation activities for pre-approval inspections
• Support interdisciplinary working teams with recommendations, advice and action plans for drug substance-related issues
• Evaluate new process technology ensuring freedom to operate and expanding the IP for the company
• Provide onsite process coverage during process validation or as needed
• Communicate drug substance related issues and information to committees, teams and interested groups
• Support corporate development activities, serving as drug substance/chemistry expert

Preferred Qualifications

No preferred qualifications provided.