Senior CMC Project Manager

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

At Bristol-Myers Squibb, we’re creating innovative medicines for patients who are fighting serious diseases. We’re also nurturing our own team with inspiring work and challenging career options. No matter our role, each of us makes a contribution. And that makes all the difference.

Job Description:

Within the Product Development (PD) division, the Portfolio Strategy and Integration (PSI) department brings together business operations, project planning and execution, and portfolio management with the vision of simplifying how Product Development runs the business. A key goal of PSI is to drive the development and execution of integrated CMC strategies via Chemistry Manufacturing Control Teams (CMC) to enable R&D Development Team objectives/deliverables. The Senior CMC Project Manager is closely partnered with the CMC Leader to enable effective execution of CMC strategy and plans. The scope of responsibilities of the Senior CMC Project Manager fall into 4 general categories which flex across all drug modalities, disease areas and stages of development.

CMC Management, including meeting planning, facilitation and documentation CMC Project Timeline Management, including maintenance of up-to-date MS project timelines and timeline scenario planning Gaps Analysis and Risks Management Allocation of drug substance and API materials for non-clinical use.

Primary Responsibilities:

The PM is a leader, coordinator, and facilitator for the Portfolio Strategy and Integration group, providing tactical direction, managing teams, and providing tactical solutions that support the overall program strategy developed by the CMC team.

Manages 4-6 CMCs (actual number determined by level of project complexity and candidate experience)

and drives execution of program strategy by fostering communication and integration of all functional area representatives on the CMC team.

Drives and manages all CMC meeting logistics including the creation of clear and concise meeting minutes that will be shared as appropriate to align all functional representatives of decisions and actions agreed upon by the team.

Facilitates sub-team meetings, as appropriate.

Is responsible for the development of a detailed CMC project plan that is aligned with the overall program strategy. Tracks all project milestones and clearly communicates status of project through the use of established PSI tools.

Leverages portfolio and program management tools to track program execution, milestones, risks, and

long range planning to ensure appropriate communication to team members and management. Examples

include the following:

PSI CMC Database

OnePager Pro

MS Project Server

DOI Tool

Right First Time Scorecard

Operational Risk Management

The PM works collaboratively with the CMC Leaders and functional leaders to track the critical operational aspects of the program(s), including monitoring key deliverables, decision points, demand planning, and critical path activities to drive delivery of project objectives which roll up to the Product Development BOW. Is responsible for contributing to the definition and execution of risk management strategies, contingency planning, supporting the development of a high performing team(s), and communication of the solutions to management.

Partners with the CMC Leader to facilitate the management of risk by scheduling meetings with the CMC team as appropriate. The Senior CMC Project Manager is responsible for capturing all gaps/risks into the appropriate PSI tools to enable effective portfolio visuals of the gaps and risks.

Coordinates and ensure appropriate allocation of drug substance and API materials for non-clinical use. The Senior CMC Project Manager may:

Lead certain cross-functional sub-team meetings as may be needed

Represent the CMC in certain governance interactions, as appropriate

Lead and/or participate in Product Development portfolio level activities including business process

improvement initiatives and resource/budgeting activities, as needed.

Experience / Qualifications:

Bachelor's degree in engineering or relevant scientific discipline with at least 5 years of relevant

experience, Masters’ degree or PhD with a minimum of 3-5 years of relevant experience.

Highly motivated self-starter that works well both in teams as well as independently.

Strong project management, business process management, and optimization skills.

Familiarity with end to end CMC drug development with an understanding of critical milestones and typical

bottlenecks preferred.

Strong organizational skills, ability to multi-task and work in a dynamic, fast paced environment.

Demonstrated ability to accomplish results and meet deadlines and commitments.

Strong interpersonal and communications skills, both oral a written.

Demonstrated analytical and logic skills with a focus on fact-based decision making.

Demonstrated proficiency in MS Project, PowerPoint, Excel and Word.

Demonstrated ability to build relationships, influence, negotiate, and drive organizational engagement.

Experience developing and/or managing program management tools to forecast budgets, timelines and resources preferred.

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com