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26 Oct 2020

Temporary CMC Project Manager (20-16683)

Axelon Services Corporation – Posted by New Brunswick, New Jersey, United States

Job Description

“This role is currently work-from-home and will move to the office environment after the COVID-19 restrictions are lifted.”

Job Description: Senior CMC Project Manager

To perform the duties of this job, the candidate must have:
– Experience in cross functional project management (preferably CMC)

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

– Ability to develop strong collaborative working relationships with stakeholders and across technical functions to drive efficient execution of CMC program strategy

– Strong organizational, interpersonal & communication skills, be agile, display an enthusiastic and collaborative attitude with peers and team members

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

This position will be a 12 month term.

Project Manager Job Description:
CMC PM is a leader, coordinator, and facilitator for the Portfolio Strategy and Integration (PSI) organization , providing tactical direction, managing teams, and providing tactical solutions that support the overall program strategy developed by the Integrated CMC team
CMC PM is expected to manage 4-5 development assets (actual number determined by level of project complexity and candidate experience) and drive execution of program strategy by fostering communication and integration of all functional area representatives on the integrated CMC development team
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.

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
• 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

How to Apply

Please send your updated resume to

Job Types: Temporary.

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