Manager, CMC Project Operations

Company: Disability Solutions
Location: New Brunswick
Posted on: October 19, 2024

Job Description:

Working with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.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 with the resources to pursue their goals, both at work and in their personal lives. Read more: .PD Portfolio Strategy & Integration (PSI)Our Portfolio Strategy and Integration team is dedicated to developing and executing CMC strategies for small molecule and biologics portfolio utilizing the brightest minds and ideas across the enterprise to drive strategic choices for Global Product Development and Supply. From candidate selection to commercial launch and life cycle management, we provide valuable project information and portfolio insights, and we lead CMC due diligence for business development opportunities. Joining PSI means you'll have the opportunity to grow and thrive through vast and diverse opportunities. You'll make a positive impact on the lives of patients while advancing professionally alongside some of the brightest minds in biopharma.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 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 CMC Project Manager fall into 4 general categories which flex across all drug modalities, disease areas and stages of development.1) Cross-functional CMC Project Management to ensure integrated execution of CMC strategy and communication2) CMC Project Timeline Management and timeline scenario planning3) Gaps Analysis and Risks Management4) Allocation of drug substance and API materials for non-clinical usePrimary Responsibilities:

• In partnership with CMC Team Leader, manage 3-5 CMC program assignments (actual number determined by level of project complexity and candidate experience) and drive execution of integrated program strategy
• Develop detailed CMC project plan that is aligned with the overall program strategy. Work collaboratively with the CMC team leaders and functions to track all project milestones
• Facilitate pertinent CMC scenario planning to address changing business/clinic needs. Gather stakeholder input, evaluate, collate, manage and communicate implications and adjustments to the overall plan
• Manage all CMC meeting logistics including the creation of clear, concise minutes
• Partner with the CMC Leader to facilitate the management and communication of program risks and mitigation strategies
• Leverage 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 ePlan, PSI CMC database, IBP, DOI Tool, Operational Risk Management
• Coordinate and ensure appropriate allocation of DS and API materials for non-clinical use
• The CMC Project Manager may: Co-lead and/or contribute to Product Development portfolio level activities including business process improvement initiatives and resource/budgeting activities, as neededExperience / Qualifications:
  • Bachelor's degree in engineering or relevant scientific discipline with at least 5 years of relevant experience / Masters' degree with a minimum of 2-6 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 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 If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing CareersWith a single vision as inspiring as Transforming patients' lives through science--- , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.On-site Protocol BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Keywords: Disability Solutions, West Babylon , Manager, CMC Project Operations, Executive , New Brunswick, New York