Landmark Bio translates groundbreaking research into life-changing medicines. We provide development, manufacturing, and regulatory capabilities to help early-stage life science innovators rapidly progress advanced therapies from bench to clinic.

Launched in 2021, Landmark Bio is an unprecedented venture bringing together the best of industry, academia and research hospitals to accelerate life sciences innovation. A public benefit company, our work advances emerging technologies, demonstrates therapeutic potential, and improves human health.

Landmark Bio is based in Watertown, Mass. Our founders include Harvard University, Massachusetts Institute of Technology, FUJIFILM Diosynth Biotechnologies, Cytiva, and Alexandria Real Estate Equities, Inc. Collaborating partners include Massachusetts General Hospital, Brigham and Women’s Hospital, Beth Israel Deaconess Medical Center, Dana-Farber Cancer Institute and Boston Children’s Hospital.

We are seeking a self-driven, team-oriented, and entrepreneurial-minded Director of Program Management to act asthe lead on client programs of varying size and complexity which are strategically important to our business. This role will lead cross-functional teams to solve challenges that affect the program scope, timeline and/or budget while meeting the overall program and business goal(s). Strong communication skills are required for coordination with the client and internal stakeholders. The Director has an in-depth understanding of the processes and systems to manage programs, including Microsoft systems and Smartsheet, with a solid understanding of the technical aspects of GMP cell and gene therapy manufacturing and awareness of Landmark Bio’s business objectives.

This is an exciting opportunity for a well-qualified candidate to join a rapidly growing company focused on turning today’s cutting-edge research into tomorrow’s breakthrough therapies. Together with our partners and collaborators, we are effecting broader changes in the healthcare industry and making a positive impact on people’s lives and our society.

Scope of Responsibilities

•Under own direction, develop, execute, and oversee the coordination of client facing programs from award stage to closure ensuring correct planning timelines are generated, monitored and updated to ensure successful adherence and completion.

•Develop and implement new PM tools for Landmark Bio (including document and presentation templates, Smartsheet dashboards, trackers, etc.) and recommend process improvements to existing PM tools and ways of working.

•Write applicable program documents including charters, program plans, program schedules, RACI matrices, risk registers, business requirements, policies and procedures, and training materials. Ensure all program documents are complete, accurate, current, and stored appropriately.

•Identify and generate documentation for changes in scope to be issued to the client.

•Lead and manage client meetings/teleconferences/onsite visits to understand full scope requirements, ensuring minutes and actions are taken and all required program documentation is generated by self or the project team.

•Provide overall program coordination and direction to multiple functional areas, including Process and Analytical Development, Supply Chain, Quality, and GMP Manufacturing.

•Coordinate program materials and the use of shared resources; identify resource constraints and assist with corrective action plans to remedy any issues.

•Manage program resources, ensuring appropriate allocation, alignment to tasks, adherence to timeline, and conflict resolution.

•Apply formal Change Management processes when substantive modifications affecting the program scope, timeline, and/or resources/budget are suggested or necessary.

•Facilitate issue resolution through analysis and collaboration; develop and present recommendations to leadership and negotiate to reach resolution.

•Identify, evaluate, prioritize, and manage program risks through application of a Risk Management process designed to minimize, monitor, and control the impact of risks to the project.

•Create and update presentations in preparation for leadership reviews and Joint Steering Committees.

•Mentor program team members to ensure Landmark Bio’s client services are world class.

Qualifications

•BA/BS degree with 10+ years relevant experience (or a combination of education and experience) is required

•PMP certification desired

•Minimum 5+ years prior experience in leading program teams in the technology transfer and GMP manufacturing of pharmaceutical, biologics, and/or cell and gene therapy products is required; client facing experience is highly preferred

•Thorough understanding and experience leading cross-function programs that include GMP manufacturing is required, experience working in a start-up environment is a plus

•High degree of proficiency in Microsoft Office Suite (Word, Excel, Outlook, MS Project and PowerPoint) and Smartsheet is required

•Strong communication, problem solving, planning, and project/program management skills

•Ability to understand scope of work contracts and implement change order documentation

•Demonstrated knowledge of project financial reporting

•Experience working in a matrixed organization, leading cross-functional project teams

•Ability to manage and participate in more than one project of a reasonable size simultaneously

•Ability to understand and impartially consider project needs among diverse colleagues in various departments both internally and from client organizations

•Ability to understand and enforce contract terms

Landmark Bio is an Equal Opportunity, Affirmative Action employer. Minorities, women, veterans, and individuals with disabilities are encouraged to apply.

#J-18808-Ljbffr

Landmark Bio

New Jobs

QC Analyst II

Director, Program Management

Director of Manufacturing