The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.
A Pharmaceutical Company is seeking a Senior CMC Project Manager in Princeton, NJ.
The Senior CMC Project Manager is closely partnered with the CMC Team Leader to enable effective development and execution of integrated CMC strategy and plans.
The scope of responsibilities of the Sen. CMC Project Manager fall into 5 general categories which flex across all drug modalities, disease areas and stages of development:
• Cross-functional CMC team Management, including meeting planning, facilitation and documentation
• Integrated CMC Project Plan Management, including maintenance of up-to-date project timelines and timeline scenario planning
• Gaps Analysis and Risks Management
• Planning and allocation of CMC drug material demand for non-clinical use
• Ensure accuracy of PM-related information in established portfolio and program management tools to track program execution, milestones, risks, and long range planning to ensure appropriate communication to team members and management
• Establish strong partnership with CMC Team Leader to shape the overall strategy and ensure successful execution of early to late stage programs in product development portfolio the comprises of small and large molecules
• Facilitate cross-functional CMC team meetings using meeting management best practices to drive timely and effective decision-making and successful execution of program objectives
• Create and manage all integrated CMC meeting logistics including the creation of clear and concise meeting minutes that are shared as appropriate to align all functional representatives of decisions and actions agreed upon by the team
• Responsible for the development of a detailed CMC project plan that is aligned with the overall program strategy
• Leverage established 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 of these tolls include (CMC Database, OnePager Pro, MS Project, ePlan/Planisware, DOI Tool, Right First Time Scorecard, Operational Risk Management)
• Work collaboratively with the CMC team 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
• 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
• Partner with the CMC team Leader to facilitate the management of risk by scheduling meetings with the CMC teams as appropriate
• Coordinate and ensure appropriate allocation of drug substance and API materials for non-clinical use.
Skills & Requirements
• 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
• 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.
You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there’s a position you really want, you’re fully prepared to get it.
Additionally, this position is a contract role where Hays offers you the opportunity to enroll in full medical, dental or vision benefits.
• Life Insurance ($20,000 benefit)
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Hays is an Equal Opportunity Employer including disability/veteran.
In accordance with applicable federal and state law protecting qualified individuals with known disabilities, Hays U.S. Corporation will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570
Drug testing may be required; please contact a recruiter for more information. #1142979