About the Role

• The Director, Chemical Development will provide leadership in strategic planning and execution of CMC activities related to drug substance development and manufacturing at CMO’s from Phase 1 through commercialization. They will also collaborate closely with the Technical Operations, Pharmaceutical Sciences, Analytical Development and Supply Chain teams to ensure continuous supply of clinical trial and commercial products.

Let’s talk about some of the key responsibilities of the role:

• 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.

Factors for Success:

• 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.
• Strategic Leadership - Translates corporate vision and strategy into departmental goals and objectives; adjusts plans and tactics to meet changing departmental priorities and circumstances; utilizes market data.
• Successful candidate will be high-energy, possess a learning orientation and the ability to work in a fast-paced environment.
• Strong communication and change management skills required, in addition to ability to build strong relationships both vertically and horizontally.
• Proven ability to escalate difficult issues and make tough decisions.

A Few Other Details Worth Mentioning:

• The position is a hybrid or remote position.
• We are passionate about our culture! Our Tarsans live our values of commitment to patients, empowerment to champion innovation, and teamwork to amplify impact!
• This position reports directly to our Vice-President of Manufacturing Operations and Supply Chain
• Some travel may be required – up to 30%

At Tarsus, we understand the importance of attracting and retaining top talent. The expected base pay range for this position is $163,500 - $228,900 plus bonus, stock equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. Our benefits include health, dental and vision insurance benefits to ensure your well-being. We believe in work-life balance and offer generous paid time off, including vacation, holidays, and personal days. For more details regarding Tarsus benefits, please visit: https://alliantbenefits.cld.bz/25tarsusbenesnap.

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