Director, CMC Product Development

Job Description
Leads global Product Presentation and Device Strategy Teams (PPDST) and Chemistry, Manufacturing and Controls (CMC) teams of functional representatives from various departments and divisions. Accountable for creating a CMC development plan in collaboration with line functions and the Asset Strategy Team (AST). Serves as the spokesperson for all CMC functions and ensures information flow among AST and various line functions and stakeholders. Partners with Clinical, Regulatory, Operations, Quality, Preclinical Safety, and Commercial organizations. Apprises CMC and Stakeholder Management of strategies, plans and risks through regular communications and periodic reviews throughout development and in support of global filings and approvals
 
 
Represents all CMC areas on the AST serving as spokesperson for the CMC project team and ensures information flow among the AST and all line functions. Ensures high quality science, technology, deliverables, and collaborates to ensure compliance with global regulatory and quality requirements. Participates in meetings with Regulatory Authorities, responds urgently to regulatory queries, and participates in Pre-Approval Inspections.
Leads the Product Presentation and Device Strategy Team (PPDST), a key deliverable team of the AST. Develops an integrated CMC strategy considering value drivers incl. patient convenience
Critically evaluates and integrates drug substance, drug product, and device inputs to CMC team strategies and plans that align with corporate business objectives. Decision-making will often require assessment and integration of physical chemical properties, formulation science, engineering, analytical, and device technical information in conjunction with the project strategy, with full consideration of current regulatory and compliance requirements.
Leads several early stage projects and one or more late stage projects in one modality area (NBE, NCE, gene/cell therapy) using matrix management approach. Mentors junior colleagues or Peers. May have direct reports.
Negotiates for additional resources when required, influences project timelines to ensure proper completion of required activities. Implements creative approaches to conserve resources, and achieves efficiency with respect to time, and budget.  Serves as a mentor for functional representatives, provides feedback and input to their functional managers and identify growth needs for team members.
Reviews contracts with Third Party Manufacturers and consultants. Develops a budget in collaboration with AST, obtains resources from functional areas and stays within the approved funding. Accountable for the success and overall CMC quality of a given project. Ensures timely execution of project plan to deliver high quality with respect to science, technology, compliance and cost effectiveness.
Leads CMC development teams for assigned projects: schedules meetings, develops agendas, issues highlights, apprise risks and plans with CMC Management, conduct periodic reviews, to ensure that phase transition criteria are met in the most efficient and resource sparing manner.
Supports and implements corporate and divisional initiatives and strategies. Promotes scientific and entrepreneurial thinking, encourage creativity and manage quality and results with respect to science, time, budget and resources.
Develops and implements a CMC product development plan and updates as necessary in collaboration with the ADT and respective line functions.
Ensures compliance with regulatory, health, safety and environmental requirements. Is always informed of developments in the global technical, regulatory and compliance arena and industry practices.
Apprises CMC Management of plans and risks through regular communications and periodic reviews throughout development and in support of global filings, approvals and launches.
Responsible for the Quality / Module 3 content of global filings of high quality CMC dossiers, approvals and commercialization of products.