Apellis Pharmaceuticals · 21 hours ago
Associate Director, Project Management (Prefilled Syringe and Combination Product Development)
United States
Full-time
Remote
Director/Executive
10+ years exp
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Responsibilities
Experience with and ability to guide teams and members to ensure effective development of drug-device combinations products including design reviews, technical reviews, the implementation of statistically justified design changes, design inputs and outputs, and appropriate risk management activities within the design control system.
Together with the project leader and team members create detailed project timelines and verify connectivity between activities. Maintain and communicate timeline changes promptly to the impacted parties.
Support the project lead and team members to create and manage an effective and productive environment for quality discussions, timely execution, decision making, problem solving, communication, transparency, and proper risk management.
Manage the project including milestones timelines, deliverables, action items, key interdependencies, applying experienced project management techniques. With the project leader pro-actively manage CDMO and foster a constructive and accountable relationship to meet deliverables. Assist with administrative activities (e.g. agreements, SOW and other)
Collaborate effectively and professionally in a matrixed environment with the different team members and stakeholders, including external partners while maintaining focus on the key success factors.
Ensure timely escalation of issues, when appropriate, to assist in problem solving and move the projects forward. Support making acceptable tradeoffs between scope, timeline, budget that are subsequently approved.
Organize meetings, develop agendas, take meeting minutes, track metrics, create reports and dashboards, and crisp documentation for key stakeholders. Support the team by facilitating material shipment between sites.
Qualification
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Required
Bachelor’s degree in science, engineering, healthcare, or business administration with prior project management experience.
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.
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.
Highly organized, service-oriented, and adept at problem-solving.
Demonstrated ability of managing projects, competing priorities, and work with various tools to lead successful projects.
Able to work in a fast-paced environment with shifting priorities and timelines.
Excellent written and verbal communication skills, able to communicate effectively with management as well as with peers.
Comfortable working independently with minimal supervision.
Excellent interpersonal and relationship management skills.
Ability to work independently, navigate ambiguity, adapt to change, and make rapid, disciplined decisions to enable agile execution.
Preferred
Project Management Professional certification (PMP)
Experience with prefilled syringe development.
Familiarity with Data Privacy and Integrity laws and best practices.
Benefits
Health insurance with full premium coverage
401K with company match
Paid time off (PTO)
Long- term disability insurance
Life insurance
Company
Apellis Pharmaceuticals
Apellis Pharmaceuticals focuses on developing novel therapeutics and drug delivery technologies to address chronic inflammatory diseases.
501-1,000 employees
H1B Sponsorship
Apellis Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (5)
2022 (6)
2021 (9)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$643.53MKey Investors
Sixth StreetSectoral Asset ManagementCormorant Asset Management
2024-05-14Post Ipo Debt· $475M
2020-01-01Post Ipo Equity· Undisclosed
2017-11-09IPO· nasdaq:APLS
Leadership Team
Cedric Francois
Co-founder, Chief Executive Officer , and President
Adam Townsend
COO
Recent News
GlobeNewswire News Room
2024-11-12
2024-11-08
Company data provided by crunchbase
