Apogee Therapeutics

Director

• Develop and deliver phase-appropriate product understanding and control strategies using QbD framework and risk assessment
• Support manufacture of clinical and commercial GMP DS throughout product lifecycle, including tech transfer, campaign analysis, and diagnostics
• Author and review technical reports, master and executed batch records, working across internal team and with CDMO partners
• Work closely with CDMO partners, providing technical oversight (including onsite Person in Plant support when required), and taking the lead in supporting investigations and resolving deviations
• Analyze process and manufacturing data to understand and optimize process performance
• Develop process characterization and PPQ strategies and documentation
• Support regulatory activities including submissions and site inspections from preparation through execution
• Liaise with DP, device development, and clinical supply chain as needed to ensure seamless end to end product delivery and robustness
• Develop and maintain cost of good models that describe process and enable sensitivity analyses for process improvements
• Collaborate closely with colleagues to ensure a seamless, highly integrated TechOps team
• Author and review internal procedures, reports, and presentations, as needed

Associate Director – Manufacturing Science and Technology

• Guide process development of protein production from lab-scale to tech transfer and GMP manufacture at CDMOs (including onsite support when required, such as Person in Plant, inspection support, etc.)
• Analyze process and manufacturing data to understand and optimize process performance
• Troubleshoot processes to identify root causes, propose corrective actions, and support resolution of deviations
• Review and approve master and executed batch records; assist with investigations
• Author and review internal procedures, reports, and presentations
• Develop process characterization and validation strategies and documentation
• Liaise with DP, device development, and clinical supply chain as needed to ensure seamless end to end product delivery and robustness
• Collaborate cross-functionally with Regulatory to author and support regulatory submissions (IND, IMPD, amendments, IB, BLA, etc.)
• Develop phase-appropriate product understanding and control strategies using QbD framework
• Create late-phase development strategy to support potential commercialization
• Collaborate closely with colleagues to ensure a seamless, highly integrated TechOps team
• Along with other TechOps team members, help shape goals and strategic vision for the TechOps organization

Director – Purification Development

• Guide process development of protein production from lab-scale to tech transfer and GMP manufacture at CDMOs (including onsite support when required, such as Person in Plant, inspection support, etc.)
• Analyze process and manufacturing data to understand and optimize process performance
• Troubleshoot processes to identify root causes, propose corrective actions, and support resolution of deviations
• Review and approve master and executed batch records; assist with investigations
• Author and review internal procedures, reports, and presentations
• Develop process characterization and validation strategies and documentation
• Support regulatory activities including submissions and site inspections from preparation through execution
• Liaise with DP, device development, and clinical supply chain as needed to ensure seamless end to end product delivery and robustness
• Collaborate cross-functionally with Regulatory to author and support regulatory submissions (IND, IMPD, amendments, IB, BLA, etc.)
• Develop phase-appropriate product understanding and control strategies using QbD framework
• Create late-phase development strategy to support potential commercialization.
• Collaborate closely with colleagues to ensure a seamless, highly integrated TechOps team
• Along with other TechOps team members, help shape goals and strategic vision for the TechOps organization

Director, Cell Culture Development

QA Engineer

• Lead and support QA activities for downstream manufacturing, including Drug Product, Finished Drug Product, and devices such as pre-filled syringes and auto-injectors
• Maintain and enhance robust GMP quality systems encompassing documentation, change control, deviations, CAPA, quality events, and continuous improvement initiatives
• Stay current with regulatory changes, industry trends, and implement new requirements into company policies and procedures
• Utilize risk-based approaches to quality management, proactively identifying and mitigating quality risks across the organization
• Develop, monitor, and report key quality metrics to drive GMP compliance and improve product quality
• Ensure all personnel are adequately trained in GMP requirements and quality procedures
• Keep comprehensive and accurate records and reports of all quality assurance activities
• Foster a culture focused on quality, compliance, data integrity, patient safety, collaboration, and teamwork
• Prepare and support the organization for regulatory authority inspections and maintain inspection readiness
• Collaborate with cross-functional teams to solve problems and drive innovation in quality systems and processes

Associate Director, GMP Quality Assurance

• Collaborate with the Clinical Strategic Excellence team to support the development and execution of the company’s clinical strategy
• Drive analysis and synthesis of both quantitative and qualitative data, including clinical trial data, scientific literature, and insights from the competitive landscape, leveraging input from multiple sources, including new insights from the Business Development & Strategy, Clinical Development, and Medical Affairs teams
• Partner with cross-functional teams to inform strategic recommendations with data-driven insight
• Optimize processes within the Clinical organization to enable program execution and further company strategy
• Support external communication about our clinical programs, including coordination of operations to support clinical data releases and development of presentations for leadership, board meetings, and external stakeholders
• Contribute to clinical strategy working groups and other ad hoc Clinical initiatives, including in-person workshops and meetings

Associate Director, Clinical Strategic Excellence

Medical Director

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Medical Director, Clinical Development – Dermatology

Attorney

• Prepare and prosecute patent applications, including drafting applications and responses to Office Actions before the U.S. Patent and Trademark Office
• Coordinate patent filing and prosecution strategy ex-US (globally) and instruct foreign counsel accordingly
• Work alongside scientific and technical colleagues to identify patenting opportunities and convert innovative ideas into patent applications
• Conduct patent and patent application landscape analyses and provide guidance to stakeholders
• Perform patentability analyses and communicate guidance to stakeholders
• Perform freedom-to-operate assessments, identify and investigate any potential risks and assist with any risk-mitigation measures
• Communicate patent-related information clearly, concisely and carefully with colleagues across functions

Director, Patent Attorney

Project Manager

• Lead the documentation flow between Tech Ops and our partners (CDMOs, external vendors) and maintain project documentation on SharePoint
• Maintain and communicate a current overview of Tech Ops documentation status and issues, including weekly dashboards to present to the upper management
• Responsible for migration of relevant Tech Ops documentation into the Veeva Quality System
• Work with various Tech Ops teams to identify resource constraints, risks, and conflicts that could impact the team’s bandwidth
• Provide Project Management support for one or more CMC programs, including building and maintaining the CMC timelines by interfacing with our external partners and facilitating cross-functional collaboration with the Tech Ops
• Collaborate closely with the cross-functional Program Management team to ensure integration of Tech Ops activities into overall program plans, monitor project deliverables and ensure tasks are on track
• Responsible for purchase order initiation in NetSuite, review and approval of vendor accruals and invoices
• Responsible for tracking all outsourced activities

Senior CMC Project Manager

• Contributor on regulatory submissions
• Provide expert statistical advice, methodological research and analysis of trial and epidemiological data to inform the design, planning and execution of Apogee’s clinical studies
• Review and/or author statistical analysis sections of protocols, statistical analysis plans, clinical study reports, regulatory documents or scientific publications, generates or reviews study randomization, and sample size/power estimations
• Oversee the vendor/CRO biostatistics teams, including activities during TFL development, Data Monitoring Safety Board meetings, interim analyses, and database locks
• Execute or oversee individual projects, which will include meeting with project/study team members, conducting exploratory analyses and graphic support, and providing analyses for publications of Apogee’s studies
• Evaluate alternative or innovative approaches to statistical methods and study design
• Build relationships with CROs and other external partners to achieve results for specific project needs
• Ensure the delivery of high quality and timely reports to project teams and clinical trial team