Director, Chemical Development

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Requirements:

• S. /M.S./Ph.D. in one of the relevant Engineering or Science fields
• Strong understanding of technical/scientific challenges as those apply to the production processes used in the manufacture of Sterile products and the subsequent packaging of those products.
• 15+ years of progressive responsibility in Technical Operations and/or manufacturing support in pharmaceutical manufacturing. (Doctorate degrees require a minimum of 6 years total experience.)
• Preferable experience in all the following areas: small molecule and large molecule API, intermediates and regulatory starting materials, site selection, technology transfer, process development, optimization, registration and validation.
• Must have strong understanding of project management systems and tools, strong business and financial skills.
• Established track record with evidence of excellent people management experience, problem solving, collaborative, leadership and communication skills.

Responsibilities:

• Lead API operations across multiple CMC programs and ensure that operational plans are consistent with overall regulatory and corporate strategies.
• Lead all aspects of the manufacture of clinical and commercial drug substance production at CMOs and ensures adherence to project timelines to support clinical and commercial supply, in line with business objectives.
• Establish and manage relationship with CMOs.
• Collaborate with CMOs to develop and lead manufacturing initiatives including, but not limited to: CMO site selection, technology transfer, scale-up, process development and optimization, validation, clinical and commercial production.
• Develop strategies to ensure that supply chains for clinical and commercial drug substance are robust. Create risk mitigation plans to ensure timelines CMC activities are consistent with overall development timelines.
• Collaborate with other internal functional groups to ensure that manufacturing activities comply with cGMPs and regulatory filings. Facilitate the resolution of deviations in a timely manner.
• Develop and manage budget for CMC programs. Collaborate with Finance to address budget variance.
• Collaborate with Regulatory Science to set CMC strategies. Author CMC regulatory submissions .
• Collaborate with Pharmaceutical Sciences to set strategies for drug substance development
• Review/approve drug substance manufacturing batch records, protocols, specifications and deviations.
• Manage Person-in-Plant coverage to provide adequate oversight for manufacturing activities.