BioCryst Pharmaceuticals

• Manage and execute data operations between BioCryst system and downstream partners • Oversee risk management and data operations of key systems. • Act as an internal advisor to various internal functional teams. • Establish and maintain a data and risk documentation repository. • Support data operations for implementation of specific system platforms. • Coordinate and manage data flows between internal sources and external vendors. • Collaborate with Commercial departments to size field force territories. • Ensure compliance with US, Japanese Canadian data privacy and security regulations.

Title: Director, Quality Control Location: US_North Carolina_Remote Full time Job Description: COMPANY: At BioCryst, we share a deep commitment to improving the lives of people living with hereditary angioedema (HAE) and other rare diseases. We leverage our expertise in structure-guided drug design to develop first-in-class or best-in-class oral small-molecule and injectable 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 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. JOB SUMMARY: The Director, Quality Control (QC) is responsible for providing strategic and operational quality oversight of all Quality Control (QC) activities supporting the development, manufacture, testing, release, and lifecycle management of small molecule, large molecule/biologic, and combination products. The Director, Quality Control provides technical leadership and scientific decision‑making for analytical control strategies, method performance, reference standards, specifications, and laboratory investigations, serving as a recognized technical authority for QC‑related matters across the product lifecycle.This role ensures QC activities are executed in compliance with global GxP regulations and internal Quality Systems. The Director serves as the primary Quality authority for QC compliance, analytical control strategy, investigation oversight, stability programs, reference standards, and test method governance, and partners closely with Analytical Development to ensure effective method design, lifecycle transfer, performance characterization, and alignment of analytical control strategies from early development through commercialization. The role also partners closely with QA GMP Operations, Global Technical Operations, Regulatory Affairs, and external testing laboratories/CMOs. ESSENTIAL DUTIES & RESPONSIBILITIES: - Provide quality and technical oversight and governance for all QC activities including raw material, in‑process, release, stability, and special testing for drug substance, drug product, and combination devices. - Ensure QC laboratories/operations operate in compliance with applicable regulations and internal standards - Act as the primary Quality escalation point for critical QC‑related quality and compliance issues. - Provide quality oversight and approval of Laboratory Investigations, (including OOS, OOT, atypical results, deviations, and data integrity events), ensuring investigations are scientifically sound, risk‑based, appropriately escalated, trended for systemic issues, and supported by effective CAPAs through closure. - Trend QC events and ensure systemic issues are identified and addressed. - Establish and maintain lifecycle management for reference standards and critical reagents, partnering with Analytical Development to define qualification strategies, potency assignment and requalification approaches, while ensuring consistent implementation across internal QC labs and external testing partners. - Provide Quality oversight and lifecycle management of the global stability program, including protocol design input and approval, execution oversight, data review and interpretation, trend analysis, and reporting while ensuring that stability studies support regulatory filings, shelf‑life assignments, and ongoing product verification. - Provide oversight for annual product quality reviews associated with QC data (e.g. OOS/OOT trends, stability data, CoAs/QC release testing). - Ensure robust processes for CoA generation, review, and approval processes for clinical and commercial materials ensuring analytical data integrity, specification compliance, and alignment with regulatory filings. - Oversee specification management, including establishment, review, approval, and lifecycle maintenance for drug substance, drug product, and combination devices in collaboration with Pharmaceutical Sciences. Ensure alignment on scientific justification and regulatory rationale, while verifying specifications are scientifically justified, phase‑appropriate, and aligned with regulatory commitments. - Partner with Regulatory Affairs to support specification‑related regulatory submissions and variations. - Provide Quality and technical oversight of analytical method validation, verification, lifecycle management, and method transfers in close collaboration with Analytical Development, including review of validation design, acceptance criteria, and method performance trends. Ensure methods are robust, controlled and compliant across external testing sites. - Lead and/or support Quality Assurance (QA) audits and regulatory inspections of QC laboratories,serving as a Quality SME. Confirm inspection observations, audit findings and regulatory commitments are effectively addressed and sustained. - Ensure QC‑related processes are appropriately defined within the Quality Management System (QMS), including SOPs, training, change control, and risk management. - Drive continuous improvement initiatives across QC processes, analytical efficiency, and compliance maturity. - Contribute QC metrics, trends, and risk assessments to Quality Management Review (QMR) and Quality Council forums. - Provide functional leadership, mentoring, and development for QA staff supporting QC oversight. - Support selection, qualification, and ongoing oversight of external QC laboratories and CMOs. EXPERIENCE & QUALIFICATIONS: - Advanced degree in Chemistry, Pharmaceutical Sciences, Biology, Engineering, or related scientific discipline (MS/PhD preferred). - Minimum twelve (12) years of pharmaceutical/biotechnology quality experience, including significant experience in QC, QA oversight of QC, and/or analytical sciences. - Demonstrated experience supporting small molecule, biologics, and/or combination device programs. - Strong working knowledge of FDA, EMA, ICH and EU GMP and global regulatory expectations for laboratory operations. - Proven experience supporting regulatory inspections and managing complex QC‑related compliance issues. Strong understanding and ability to implement risk management fundamentals/tools. - Experience with statistical analysis of analytical data and method capability with strong scientific and analytical judgment. - Deep understanding of laboratory investigations and data integrity. - Demonstrated ability to apply scientific judgment to analytical data interpretation, method performance issues, and complex laboratory investigations. - Excellent organizational skills and ability to work on multiple projects with competitive timelines is required. - Excellent communication, negotiation, and presentation skills; maintains high ethical standards, and enjoys working with people and information, making decisions, problem solving, making a difference and working in a leadership role. - Demonstrated ability to work effectively in cross functional team environment and independently in a remote work setting, as necessary. - Excellent problem-solving and decision-making skills. 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 This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

Title: Paralegal, Generalist Location: US_North Carolina_Remote Full time Job Description: COMPANY: At BioCryst, we share a deep commitment to improving the lives of people living with hereditary angioedema (HAE) and other rare diseases. We leverage our expertise in structure-guided drug design to develop first-in-class or best-in-class oral small-molecule and injectable 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 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. JOB SUMMARY The Paralegal, Generalist provides broad-based legal and operational support across the Legal and Compliance function. This role supports contract lifecycle activities, manages discrete legal and compliance-related projects, and serves as a key coordination point between attorneys, business stakeholders, and external partners. The position operates in a highly collaborative and fast-paced, regulated environment. ESSENTIAL DUTIES & RESPONSIBILITIES Contracting & Legal Support - Support the end-to-end contract lifecycle, including intake, tracking, drafting support, review coordination, execution, and archival of agreements. - Prepare and manage standard form agreements (e.g., NDAs, employment agreements, separation agreements, consulting agreements, vendor agreements, amendments) using approved templates and playbooks. Coordinate contract review and approval workflows between attorneys, business owners, and external parties. - Maintain contract records in contract management systems and shared repositories, ensuring accuracy, completeness, and version control. - Monitor key contract milestones, renewals, expirations, and obligations; prepare reports and summaries as needed. - Assist attorneys with legal research, document review, and preparation of supporting materials, as appropriate. - Maintain deadlines, generate status reports, and ensure timely completion of tasks. - Ability to provide supplemental support and manage calendars for C Suite attorney when necessary. Project Management & Operational Support - Manage and track legal and compliance-related projects, including timelines, deliverables, dependencies, and status reporting. - Coordinate cross-functional stakeholders to ensure projects move forward efficiently and deadlines are met. - Develop and maintain project plans, trackers, dashboards, and meeting materials. - Support process improvement initiatives related to contracting, legal operations, and compliance workflows. - Assist with implementation and ongoing use of legal systems and tools (e.g., contract lifecycle management platforms, intake tools). - Assist with the creation of Purchase Orders and spend tracking for Legal vendors. Compliance & Administrative Support - Support compliance and governance activities by maintaining documentation, logs, and audit-ready records. - Assist with tracking training, certifications, disclosures, and other compliance-related requirements, as directed. - Prepare reports, summaries, and presentations for Legal and Compliance leadership. - Handle confidential and sensitive information with discretion and professionalism. EXPERIENCE & QUALIFICATIONS Required: - Bachelor’s degree or paralegal certificate from an accredited program. - 3+ years of experience in a paralegal, legal operations, contracts, or related role. - Experience supporting contracts and managing multiple projects simultaneously. - Strong organizational, project management, and prioritization skills. - Excellent written and verbal communication skills. - High level of attention to detail and accuracy. - Proficiency with Microsoft 365 (Word, Excel, PowerPoint, Outlook, Teams, SharePoint). - Able to thrive in a fast-paced, dynamic environment with a high degree of professionalism and confidentiality. Preferred: - Experience in the pharmaceutical, biotechnology, healthcare, or other regulated industry. - Familiarity with employment-related agreements and human resource matters. - Familiarity with contract lifecycle management tools and legal intake workflows. - Exposure to compliance, governance, or audit support activities. 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 This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

• Oversee the Global External Vendor Management program for all BioCryst GxP outsourced activities, including GCP, GLP, GMP, GDP, and GVP vendors. • Responsible for oversight of all new vendor qualification activities and ongoing vendor lifecycle management. • Ensure oversight of the initial qualification and continued QA management of external GxP vendors. • Develop and maintain the Vendor Qualification Program including annual audit plans, coordinating and/or conducting audits. • Support implementation and management of Quality Assurance agreements for external vendors. • Enhance and maintain the approved vendor list. • Oversee assessment of vendor reported changes and associated internal vendor change controls. • Supports deployment of operational excellence strategies internally and at external GxP vendors. • Identifies quality improvements to BioCryst Quality Systems. • Ensures oversight of vendor corrective actions to resolve quality and technical problems identified for all GxP vendors. • Ensures that critical and major issues are escalated as per standard procedures to management and are resolved within stated timelines. • Assesses and supports Internal and External GxP vendor readiness for Health Authority inspections. • Support Internal cross functional Quality System audits.

• The Assoc. Director, Medical Affairs Training is responsible for the implementation and execution of the training programs for Medical Affairs. • Will support training requests from cross-functional collaborators. • Responsible for enhancing the skills of the Medical Affairs colleagues. • Training will include onboarding, product training, skills development, virtual training and advanced training reflecting the needs of the organization. • Collaborate with Medical Directors to conduct needs analysis to ensure training alignment with global and regional medical strategies and legal/compliance/regulatory requirements. • Lead all medical training, including new hire training, virtual training, product and disease training, other skills training, and advanced training, training on new and existing initiatives and field materials, including internal journal clubs etc. • Collaborate with cross functional and medical leadership to provide feedback and input on ways to improve training programs, structure, and resources and to proactively analyze, assess and report the impact of training programs, including measurements of effectiveness post-training. • Collaborate with medical teams in the development of external communication materials for field teams and lead training thereof, including e.g. new publications, congress materials, medical website content.

• Develop and implement national and provincial market access and stakeholder engagement strategies. • Lead development and submission of HTA dossiers to bodies such as CDA and INESSS. • Lead negotiations with pCPA and provinces to secure PLAs. • Build, maintain, and strengthen senior-level relationships with public and private payers. • Monitor and assess ongoing health policy challenges and opportunities.

• Own the day to day operational enablement of Microsoft 365 Copilot across the enterprise • Configure, test, enable, and maintain Copilot features, settings, and options within the Microsoft ecosystem • Ensure Copilot remains functional, secure, and usable as Microsoft introduces updates and new capabilities • Partner with IT security, infrastructure, applications, and service teams to align AI enablement with operational standards • Translate AI capabilities into practical, repeatable use cases that improve employee productivity • Work directly with BioCryst business and functional departments to support AI implementation within their systems and workflows • Help departments identify opportunities where AI can improve efficiency, accuracy, or decision‑making • Own IT training and enablement for new hires, system changes, and technology rollouts • Develop and maintain clear, accurate IT documentation and self‑service resources