Exec. Director, Commercial MS&T

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 Executive Director, Commercial Manufacturing Sciences and Technology (MS&T) will be part of the Global Supply Chain team. The incumbent will lead the Commercial MS&T organization to support the successful end to end manufacturing (raw material thru finish goods) of BioCryst's commercial products. This is a highly visible role within BioCryst and will be influential in the strategic and tactical aspects of the Technical Operations organization (Supply Chain, Regulatory Affairs, CMC and Quality).

The Exec. Director, Commercial MS&T will work cross functionally to ensure Commercial Manufacturing, Packaging, Analytical Services and Daily Technical/Quality Reviews run uninterrupted. They will partner with Supply Chain, Quality, Regulatory Affairs, CMC and Commercial Operations to define and implement manufacturing strategies for our commercial products. The incumbent will be responsible for managing external CMO technical manufacturing activities. This role will also be accountable for technology transfer, process optimization, process validation, and routine technical support for our external manufacturing network. The Exec. Director, Commercial MS&T will also drive technology development and innovation to implement state of the art and robust manufacturing processes that comply with current regulatory expectations and relevant quality guidelines. The successful candidate will also provide leadership in defining process control strategies and development of plans to support late-stage and commercial transition readiness. Additionally, the Exec. Director, Commercial MS&T will provide technical and strategic input and support for the preparation of regulatory submissions and health authority interactions. This position will directly manage the Commercial MS&T team.

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ESSENTIAL DUTIES & RESPONSIBILITIES:

•Manage Commercial MS&T activities to support all technical aspects of external manufacturing of BioCryst commercial products
•Provide technical leadership to ensure that current and new commercial manufacturing processes are robust, efficient, and meet current quality and regulatory expectations
•Provide oversight to Commercial MS&T group for effective management of CMO interactions for the development and manufacture of BioCryst products
•Provide oversight to the Technical Transfer process to ensure appropriate inputs into process design considerations as well as for equipment and material selection. Work cross-functionally with development, supply chain, and analytical groups to manage successful technology transfers that meet established quality targets, timelines, and budgets
•Provide technical leadership to define phase appropriate process qualification/validation activities and process control strategies for product manufacture to support clinical development and commercial registration
•Apply the principles of Quality by Design to define technical risk assessment approaches to guide process development, optimization, and characterization studies
•Implement and manage data tracking and trending program to monitor process performance at all external commercial CMO's
•Identify industry best practices and technical innovation for process validation, technology transfers, and process optimization for BioCryst products
•Support preparation and review of technical and manufacturing documentation (e.g. protocols, process descriptions, batch records, SOPs, technical reports, etc.). Interface with external partners and internal QA and QC groups to support review of data, trending of data, quality investigations, change controls, etc.
•Support preparation and review of regulatory submissions (IND, briefing packages, responses to questions) and provide strategic and technical support for interactions with health authorities
•Develop short- and long-term strategic plans for the Commercial MS&T function that are aligned with BioCryst's plans to support development and commercialization of pipeline products
•Responsible for organizational design and staffing decisions for the Commercial MS&T function. Recruit, retain, train, and develop team members
•Build and sustain employee engagement by creating a culture of efficient execution and an environment in which individuals and teams can excel and continuously improve; establish an effective technical and leadership development plan for the Commercial MS&T organization
•Other duties as assigned.

EXPERIENCE & QUALIFICATIONS:

•MS or PhD in engineering or science discipline (biochemical engineering, pharmaceutical sciences, biology, biochemistry) or equivalent combination of education & experience in related field
•12+ years of experience in the biopharmaceutical industry in small molecule product and process development from late-stage development to full commercial operations
•Deep expertise in upstream process, downstream process and/or drug product development and technology transfer of small molecule products
•Experience in authoring regulatory submissions (INDs, briefing packages, BLAs)
•Experience in good documentation practices, data archiving, and statistical approaches to support data trending and stability analyses
•Demonstrated experience in successfully working in a cross-functional model interfacing with Quality, Regulatory, CMC, Finance, Commercial Supply Chain, and Supply Chain Support Services.
•Excellent planning, organization, prioritization, and management skills to direct the work of others on assigned projects, including internal teams and external collaborators
•Demonstrated ability to create and foster effective teamwork, build relationships, motivate others, work in a matrix organization, and collaborate at all organizational levels
•Results oriented, with a sense of urgency; strong initiative, accountability, and willingness to take ownership and drive projects to completion
•Comfortable with "rolling up the sleeves" and executing the work needed to support the success of projects in a small company environment
•Strong critical thinking and problem-solving skills
•Excellent communication skills, both verbal and written, and the ability to interface effectively with all levels of the organization. Strong communication skills with outside contract organizations

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.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)
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