COMPANY:
At BioCryst, we share a deep commitment to improving the lives of people living with complement-mediated and other rare diseases. For over three decades we’ve been guided by our passion for not settling for “ordinary” in our quest to develop novel medicines. We leverage our expertise in structure-guided drug design to develop first-in-class or best-in-class oral small-molecule and protein therapeutics, led by the efforts of our team of expert scientists in our Discovery Center of Excellence in Birmingham, Alabama. Our global headquarters is in Durham, North Carolina, our European headquarters is in Dublin, Ireland and our employees span the globe across sites in multiple countries. We are proud of our culture of engagement and accountability that rewards people for innovative thinking and achievement of key objectives. For more information, please visit our website at www.biocryst.com or follow us on LinkedIn and Instagram.
JOB SUMMARY:
The Director, Commercial Product Operations will lead several key strategic operational project plans across BioCryst’s commercial portfolio ensuring alignment with corporate strategic and functional objectives. This person will provide knowledge-based leadership, coordination and management for multiple projects to successfully expedite post-approval changes, transfers and improvement projects to provide business continuity and execute risk mitigation strategies. #LI-Remote
ESSENTIAL DUTIES & 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.
• Responsible for aligning the areas of drug substance, drug product formulation, transfers and validation into cohesive project plans that supports the company’s overall MS&T strategy.
• Develop MS&T strategy for commercial supply and responsible for communicating and seeing strategy through execution. Acts as strategic MS&T leader for all project material needs.
• Provide strategic direction for business-critical projects based upon technical input, supply needs, vendor capabilities and internal resources.
• Lead the establishment of operational plans that optimally integrate the 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 where applicable as well as ensuring project risks are identified and mitigated.
• Collaborate on prioritization, budgets and resource allocation for the MS&T function. Recommend and implement strategies for project accelerations without risk to quality
• Establish and ensure that the cGMP compliant policies, processes, procedures and best practices are consistently executed across the manufacturing operations and provide leadership and guidance on policy related matters.
• Troubleshoots and resolves issues impending deliverables; proactively demonstrates the ownership to achieve on time and on budget delivery
• Maintain a contemporaneous working knowledge in cGMP requirements
• Manage the overall operational, budgetary, and financial responsibilities and activities of the manufacturing operations with our established suppliers, while working with other departments or vendors on potential budgetary impacts.
• Partner with drug substance, drug product formulation technical experts while providing strategic input and project management for process improvements and technology transfers.
• Oversee all external manufacturing vendors while ensuring cGMP compliance
• Other duties that may reasonably be assigned from time to time by the company
EXPERIENCE AND QUALIFICATIONS:
• Bachelor’s degree in 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 be a collaborator and work effectively in cross functional team environment.
• Must have exceptional communication/presentation skills,
• Travel up to 25%, as needed, with some international travel expected.
The statements in this position description are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time.
BioCryst is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, BioCryst is committed to achieving its business objectives in compliance with all federal, state and local law.
