Director, CMC Product Development

3 weeks ago

North Chicago Illinois, United States AbbVie Full time
Job Description

 

Manages multiple projects and contributes to project prioritization. Represents AbbVie on high profile partnerships and collaborations with other pharma/biotech companies and at the Joint Development Committee level driving joint decisions for the development programs. Key member of Asset Strategy Team (AST) and ensures CMC strategy is closely aligned with the clinical and regulatory development strategy. May lead multiple  PPDST/CMC teams from GLP tox through IND and cPoC towards tec transfer to commercial sites. May supervise or mentor other PDD(s) and/or develops and implements PM or training tools. Lead R&D wide or DevSci wide initiatives and strategies Leads a global CMC team of functional representatives from various departments and divisions. Accountable for creating a CMC development plan in collaboration with line functions and the ASDT. Serves as the spokesperson for all CMC functions and ensure information flow among ADTAST/ALB and various line functions. Partners with Clinical, Regulatory, Operations, Quality, Preclinical Safety and Commercial Organizations. Apprises CMC Management of strategies, plans and risks through regular communications and periodic reviews throughout development and in support of global filings and approvals. 

Major Responsibilities:

Represents all CMC areas on the ADTAST serving as spokesperson for the CMC project team and ensures information flow among the ADTAST 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 as needed. 

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. 

Manages multiple projects and contributes to project prioritization. Negotiates for additional resources when required, influences project timelines to ensure proper completion of required activities. Implements creative approaches to conserve resources, and achieve 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 external partners and consultants. Develops a budget in collaboration with ADTAST, 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. 

Represents AbbVie on high profile partnerships and collaborations with other pharma/biotech companies and at the Joint Development Committee level driving joint decisions for the development programs. 

Promote scientific and entrepreneurial thinking, encourage creativity and manage quality and results with respect to science, time, budget and resources. 

Ensures compliance with regulatory, health, safety and environmental requirements. Stay abreast of developments in global technical, regulatory and compliance arena and industry practice. 

Apprises CMC Management of plans and risks through regular communications and periodic reviews throughout development and in support of global filings. 

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