Associate Director (AD), CMC Program Management will be responsible for project and program management support for our cross-functional CMC teams which can be based out of Cambridge or Toronto location. The AD, CMC PM will collaborate with CMC Program Leads to develop and oversee timelines and critical milestones, and ensure that the direction, coordination, implementation, control and completion of projects are achieved, while remaining aligned with the program and company strategy, commitments and goals. The AD, CMC PM oversees initiating, planning and executing Cell+gene CMC combo programs, and will coordinate planning/tracking meetings and associated minutes, actions, risk management, and decisions tracking.
The primary focus of the CMC PM will be to manage critical projects in support of specific Cell+gene combo product programs spanning initiating, planning, executing, facilitating decision-making, communicating, owning risk management process and ensuring both near- and long-term factors in our CMC strategy are considered. This includes partnering with the project leads to identify scope, work and program strategy. The PM is responsible for developing detailed program plans in support of the program and project scope and cross-functional stakeholders. This position works closely with the Program Lead, CMC Leads, Workstream Leads and Program and functional PMs in order to coordinate and organize the deliverables associated with the BRT combo product programs. This position may also need to work closely with functional leadership and representatives to ensure alignment and coordination across BRT and Tech OPS priorities. This role will also assist in business analysis for projects and programs; helping teams to define processes, criteria, etc. in order to support key decisions.
The AD, CMC PM will use BRT and Portfolio best practices, tools and templates. CMC PMs may be called upon to provide training and coaching for functional project managers. The successful candidate will support a robust CMC PM structure: share ideas, tools, best practices, training, lessons learned, establish core competencies, conduct peer reviews of program & project management deliverables, etc.
The successful candidate will be a demonstrated leader with the breadth of professional experience and the drive to work with both internal and external partners to define and implement effective project management plans. Must have the ability to work in a highly matrixed and cross-functional organization, against tight deadlines, and with world-class partners, suppliers and business leaders alike. Position reports to the Sr. Director Tech Ops Program Management
Responsibilities:
- Collaborating and communicating effectively with cross-functional CMC Teams, CMC Leads, Workstream teams and leads, Program Team, and other stakeholders to ensure successful achievement of goals and commitments as aligned with the respective program teams
- Support CMC Teams by:
- Provide strong team leadership and drive to ensure projects are executed within scope, on-time and within budget
- Create integrated project plans; scope, work, resources, scheduling, etc.
- Facilitate the definition of project scope, goals and deliverables were applicable
- Develop and maintain integrated CMC program timeline
- Drive risk management process, i.e., identification through mitigation
- Coordinate meetings and meeting logistics, keeping clear minutes, actions, decisions, and tracking associated follow-through
- Partner with key stakeholders leads to successfully achieve program and project objectives
- Partner with CMC Program Managers and CMC Leaders to drive Tech Ops strategy via the Tech Ops project portfolio by successfully prioritizing, scoping, and executing projects.
- Monitor execution and quality to BlueRock standards
- Identify and resolve issues, offer viable solutions and opportunities as they arise
- Report on program and project progress
- Implement appropriate project change control
- Manage resources to make sure schedule is on track
- Provide structure and leadership across departments to ensure team meets project objectives
- Work with internal and external stakeholders to manage deliverables, e.g. CMO’s, Supply Chain, etc.
- Develop and communicate status to Tech Ops PMO, Program and TechOPS Leadership
Minimum Requirements:
- Bachelor’s degree in Life Sciences or engineering-related discipline
- Advanced degree in Life Sciences-related discipline and/or an MBA strongly preferred
- Project management qualification preferred; PMI’s Project Management Professional (PMP) or equivalent
- 8+ years’ experience in bio tech/life sciences project management
- 13+ years’ experience in bio tech, cell therapy industry
- Track record of handling several projects simultaneously
- Experience in cellular therapy is preferred
- PMP certification preferred; PMO experience preferred
- Proficiency with related software tools such as: MS Project, OnePager, Smartsheet, MS PPT, MS Excel, etc.
- Experience in Agile teams a plus
- Strong knowledge of biopharma industry
- Excellent interpersonal, leadership, communication, and presentation skills
- Ability to work cross-functionally, with matrixed teams; maintaining strong business partner relationships
- Expertise in conflict resolution
- Excellent problem-solving skills
- Willingness to do what needs to be done in a dynamic environment
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