Drive the development and execution of integrated CMC strategies via Chemistry Manufacturing Control Teams (CMC) to enable R&D Development Team objectives/deliverables.
Closely partnered with the CMC Leader to enable effective execution of CMC strategy and plans.
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.
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 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 cross-functional sub-team meetings, as appropriate.
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.
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
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
MS Project Server
Right First Time Scorecard
Operational Risk Management
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.
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
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.
Lead certain cross-functional sub-team meetings
Represent the CMC in certain governance interactions
Lead and/or participate in Product Development portfolio level activities including business process improvement initiatives and resource/budgeting activities
Bachelor's degree in engineering or relevant scientific discipline with at least 5 years of relevant experience; OR
Masters’ degree; OR
PhD with a minimum of 3-5 years of relevant experience.
Highly motivated self-starter that works well both in teams and 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 and 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.