Associate Director, Project Management (Prefilled Syringe and Combination Product Development)

Position Summary:

The Associate Director, Project Management for Prefilled Syringe and Combination Product will support Apellis Tech Ops cross-functional teams, including members from Device, CMC, Quality, Regulatory, Supply and external contract service providers, to develop and execute project plans on time. 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.This individual will report to the head of Operational Excellence within Technical Operations and drive the teams towards success and perform end-to-end project management responsibilities according to the needs of the projects and teams.

Key Responsibilities Include:

• Experience with and ability to guide teams and members to ensure effective development of drug-device combinations products including design reviews, technicalreviews, the implementation of statisticallyjustified 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.

Education, Registration & Certification:

• Bachelor's degree in science, engineering, healthcare, or business administration with prior project management experience.
• Preferred: Project Management Professional certification (PMP)

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.
• 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.

Skills, Knowledge & Abilities:

• 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.

Physical Demands and Work Environment:

This is largely a sedentary role; however, some filing is required. This would require the ability to lift files, open filing cabinets. This job operates in a professional office environment and routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Travel Requirements:

• Expected travel to be 20%

Benefits and Perks:

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! Visit https://apellis.com/careers/ to learn more.

Company Background:

Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that combines courageous science and compassion to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two approved medicines targeting C3. These include the first and only therapy for geographic atrophy, a leading cause of blindness around the world. With nearly a dozen clinical and pre-clinical programs underway, we believe we have only begun to unlock the potential of targeting C3 across many serious diseases.

For more information, please visit http://apellis.com or follow us on Twitter and LinkedIn

EEO Statement:

Apellis is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. Apellis strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumoconiosis or any other characteristic protected under applicable federal, state or local law.

For San Francisco postings: Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.

Other Duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.