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CMC Product Development Director

Research & Development
1804314 Requisition #
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The Ideal Candidate Will: 
  • Lead a global Chemistry, Manufacturing and Controls (CMC) team of functional representatives from various departments and divisions. 
  • Develop a CMC development plan in collaboration with line functions and the Asset Development Team (ADT). 
  • Serve as a CMC spokesperson for all CMC functions and ensure information flow among ADT/ALB and various line functions. 
  • Partner with Clinical, Regulatory, Operations, Quality, PCS, and Commercial organizations. 
  • Apprise CMC Management of plans, risks through regular communications, periodic reviews in support of global filings, approvals, and launches.

Key Responsibilities Includes:

  • Represents all CMC areas on the ADT serving as spokesperson for the CMC project team and ensures information flow among the ADT and all line functions. Ensures high quality science, technology, deliverables, and certifies compliance with global regulatory and quality requirements. Participates in meetings with Regulatory Authorities, responds urgently to regulatory queries, and participates in Pre-Approval Inspections.
  • Manages a limited number of projects utilizing matrix management approach. 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 Third Party Manufacturers and consultants. Develops a budget in collaboration with ADT, obtains resources from functional areas and stays within the approved funding. Accountable for the success and overall CMC quality of a given project. Ensure timely execution of high quality deliverables with respect to science, technology, compliance and cost effectiveness.
  • Lead 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.
  • Support and implement corporate and divisional initiatives and strategies. Promote scientific and entrepreneurial thinking, encourage creativity and manage quality and results with respect to science, time, budget and resources.
  • Develop and implement a pre-clinical development plan and update as necessary in collaboration with the global development team and respective line functions.
  • Ensures compliance with regulatory, health, safety and environmental requirements. Stay abreast of developments in global technical, regulatory and compliance arena and industry practice.
  • Apprise CMC Management of plans and risks through regular communications, periodic reviews, in support of global filings, approvals and launches.
  • Responsible for the global filings of high quality CMC dossiers, approval and commercialization of products.
  • Bachelor’s Degree with at least 10-15 years of experience with different CMC functions required; Master’s Degree with at least 8-12 years of relevant outstanding experience preferred; PhD Degree with at least 6-10 years of experience with past history of significant accomplishments to effectively manage and direct global teams and all CMC activities with respect to science, technology, quality, regulatory and compliance requirements, budget and resources highly preferred.
  • At least 6-8 years’ experience in a Principle Analyst/Formulator/Process position.
  • Total combined minimum years of experience 6-13 required.
  • Must possess good scientific writing skills and good verbal skills.
  • Must have a good working knowledge of regulatory requirements and familiarity with relevant research instrumentation and techniques.
  • Knowledge of pharmaceutical theory and the drug development process.
  • Must have CMC interdisciplinary experience and expertise.
  • Possess negotiating, influencing, leadership skills.
  • Creative in implementing entrepreneurial thinking and make smart business decisions.
  • Ensure high level of morale in the CMC team.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled

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