Director of Commercial Product Operations
23 hours ago
At BioCryst, we are committed to improving the lives of people living with rare diseases. We are seeking a highly skilled Director, Commercial Product Operations to lead strategic operational project plans across our commercial portfolio. This individual will provide knowledge-based leadership, coordination, and management for multiple projects to successfully expedite post-approval changes, transfers, and improvement projects.
Key Responsibilities:
- Provide project leadership and technical oversight of manufacturing services, managing business relationships, and leading cross-functional teams of technical and functional experts from internal and external sources.
- Align the areas of drug substance, drug product formulation, transfers, and validation into cohesive project plans that support the company's overall MS&T strategy.
- Develop MS&T strategy for commercial supply and communicate and execute the strategy.
- Provide strategic direction for business-critical projects based on technical input, supply needs, vendor capabilities, and internal resources.
- Lead the establishment of operational plans that optimally integrate commercial supply strategies and operational plans, including successful product transfers, regulatory approvals, and validation.
- Identify and recommend improvements in post-approval product life cycle processes, strategies, and plans.
- Apply scientific chemical experience, including technical guidance, and ensure project risks are identified and mitigated.
- Collaborate on prioritization, budgets, and resource allocation for the MS&T function.
- Establish and ensure that cGMP-compliant policies, processes, procedures, and best practices are consistently executed across manufacturing operations.
- Troubleshoot and resolve issues impending deliverables.
- Maintain a contemporaneous working knowledge in cGMP requirements.
- Manage operational, budgetary, and financial responsibilities and activities of manufacturing operations with established suppliers.
- Partner with drug substance, drug product formulation technical experts to provide strategic input and project management for process improvements and technology transfers.
- Oversee all external manufacturing vendors to ensure cGMP compliance.
Requirements:
- Bachelor's degree in a relevant technical field required; Master's or PhD degree in chemistry, engineering, or pharmaceutically relevant science preferred.
- Minimum of 10 years' experience in the pharmaceutical/biotechnology industry working in technical and operations support roles, including product and analytical development.
- Minimum of 5 years' experience in managing projects and vendors related to post-approval commercial products.
- Strong analytical, mathematical, and critical thinking skills.
- Demonstrated ability to collaborate and work effectively in a cross-functional team environment.
- Exceptional communication and presentation skills.
- Travel up to 25%, as needed, with some international travel expected.
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