Sr. Project Manager, Operational Excellence

Waltham, MA, United States

Position Summary

The Senior Manager, Project Management supports Apellis Tech Ops Program Leads and cross-functional teams with internal members from CMC, Supply, Quality and Regulatory and external contract manufacturers and service providers to develop and execute project plans successfully. The candidate will be an active contributor to developing the overarching Technical Operations (TO) program plan, managing risks, and helping to drive deliverables among disparate workstreams into meaningful integration points through skilled project management and a foundational knowledge of Product development and Manufacturing. 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

Core Technical Development Team (TDT) member

Together with the project leads and team members create prioritized project timelines and verify connectivity between activities. Maintain and communicate timeline changes promptly to the impacted parties.

Support the project leads and team members in creating an effective and productive environment for quality discussions, timely execution, decision making, problem solving, communication, transparency, and proper risk management.

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.

Manage the project including milestones timelines, deliverables, action items, key interdependencies, applying experienced project management techniques as needed.

Organize meetings, develop agendas, take meeting minutes, track metrics, create reports and dashboards, and crisp documentation for key stakeholders.

Education, Registration & Certification

Bachelor’s degree in science, engineering, healthcare, or business administration with prior project management experience.

Preferred: Project Management Professional certification.

Experience

8 years’ experience as a Project Manager working in the medical device or pharmaceutical industry, interfacing with functional leaders from CMC, Quality, Supply Chain, and Regulatory.

Skills, Knowledge & Abilities

Good understanding of Medical Device and/or Combination Products development and compliance.

Contribute towards an effective and well-functioning team, closely aligned with program and project leader(s).

Outstanding cross-functional communication with team and stakeholders, including external partners.

Drive team towards execution, decision making, problem solving, communication in a constructive manner.

Effectively manage project risk by engaging with subject matter experts and workstream leaders

Appropriate and timely documentation and tracking of project plans, timelines, deliverables, decisions, minutes, etc.

Demonstrated interpersonal and leadership skills to build strong professional relationships and lead cross-functional team towards success.

Track record in successful delivery of projects which may 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.

Highly organized, service-oriented, problem solver with sense of urgency.

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.

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

Travel estimated at 15%

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.

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