Associate Director - Project Management, Prefilled Syringe and Combination Product Development

October 29

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Apellis Pharmaceuticals

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Targeted C3 Therapies • Complement System • Hematology • Ophthalmology • Nephrology

501 - 1000

Description

• The Associate Director, Project Management for Prefilled Syringe and Combination Product will support Apellis Tech Ops cross-functional teams. • The successful candidate will be a key contributor managing the overarching project plan, proactively manage risks and escalate as needed. • Drive deliverables among separate workstreams to meaningful integration points through foundational knowledge in combination product development. • Organize meetings, develop agendas, take meeting minutes, track metrics, create reports and dashboards, and crisp documentation for key stakeholders.

Requirements

• Bachelor’s degree in science, engineering, healthcare, or business administration with prior project management experience. • Preferred: Project Management Professional certification (PMP). • 10+ years of experience in project management within the pharmaceutical or medical device industry, working with functional leaders in CMC, Device, Quality, Supply Chain, and Regulatory. • Experience working in an ISO 13485 compliant quality management system. • Deep understanding of design controls and how they apply to combination product development. • Project management experience leading combination product development. • Preferred: Experience with prefilled syringe development. • Demonstrated interpersonal and leadership skills to build strong professional relationships and lead cross-functional team towards success. • Demonstrated track record in successful delivery of projects which include third party collaborations and internal cross-functional groups. • Good documentation and tracking discipline of relevant project management information. • Smartsheet, OneNote, SharePoint experience or willingness to learn. • Familiarity with GxP regulations. • Familiarity with Data Privacy and Integrity laws and best practices is preferred.

Benefits

• Apellis offers a great benefit package which includes: health insurance with full premium coverage. • 401K with company match. • Paid time off (PTO). • Long-term disability insurance. • Life insurance and more!