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- Establishes and oversees implementation of the overall CMC strategy for all products in development stages ranging from lead optimization and preclinical studies through global Phase 3 clinical trials, registration batches, and process performance qualification.
- Develops, oversees, and takes responsibility for CMC operational budgets and resource planning to meet business objectives.
- Negotiates and administers contracts with key contractors, consultants, suppliers, and contract manufacturing organizations. Performs on-site visits as needed to key suppliers globally.
- Prepares and reviews Technical/Quality Agreements to ensure that outsourced activities are conducted in compliance with cGMPs and exercise appropriate oversight of these activities.
- Develops long-term strategies to establish a robust commercial supply chain, enact appropriate risk mitigation procedures, monitor and identify future market trends.
- Works with company leadership to build internal CMC team and ensure team has appropriate skills, capabilities, and resources to meet current and future business needs.
- Ensures all development, manufacturing, and process performance qualification activities are completed in accordance with quality and regulatory expectations to support relevant global regulatory submissions.
- Participates in regulatory CMC strategy development, identifies gaps, and proactively provides risk mitigation strategies for the regulatory submissions required for clinical trial and marketing applications.
- Reviews, edits and provides input into CMC regulatory submissions (e.g., IND, CTA, NDA, and MAA, BLA).
- Participates in and represents CMC in meetings with global regulatory agencies.
- Discusses and presents CMC information and manufacturing plans/updates to internal teams and business partners, as required.
- Builds and maintains strong relationships with all external and internal stakeholders, including alliance partners, to ensure that performance targets are met or exceeded.
Education and Experience Requirement
- PhD in chemistry, pharmaceutical sciences, chemical engineering, or a related discipline with at least 15 years of pharmaceutical drug synthesis and scale up, pharmaceutical product design and process development
- Demonstrated experience with at least one or more of the following: small molecule solid oral dosage forms, inhaled compounds, and biologics.
- Leadership experience over a team of CMC scientists and/or engineers, leading cross-functional projects, and delivering results within tight project deadlines.
- Experience managing within a virtual manufacturing environment or a smaller biotech organization is preferred.
- Demonstrated ability to select and manage CMOs for pilot-scale through commercial manufacturing, including contract negotiation.
- Demonstrated expertise in taking a product through to commercial launch.
- Proven understanding of US, EU, and other global regulations and requirements.
- Experience in authoring CMC documents for regulatory submissions and solid understanding of pharmaceutical development, quality, and regulatory issues associated with product approvals.
Other Job Requirements
- Positive attitude and willing to roll up her/his sleeves to get the job done; ability to pay close attention to detail and step back and think strategically
- Strong interpersonal verbal, written and presentation skills in communication with internal and external parties
- Nonstandard working hours and domestic / international travel will be required periodically