Director, CMC Product Development

Advance your career as Director CMC Product Development where youll oversee the CMC aspects of drug and combination product development across programs align strategy with clinical and regulatory goals and lead a global cross-functional team. Collaborate with key partners communicate critical updates to senior management and drive robust CMC plans in support of global filings and approvals. Ideal candidates bring deep CMC drug development and team leadership experience strategic vision and a strong record in supporting clinical and regulatory milestones.

Join us to shape the future of global drug development.

Responsibilities

• Serves as spokesperson for CMC on the Asset Development Team promoting effective information flow and collaboration across all line functions
• Ensures excellence in science technology and deliverables while maintaining compliance with global regulatory and quality standards including active participation in meetings with authorities and pre-approval inspections
• Critically evaluates and integrates drug substance product and device inputs into CMC strategies aligned with business and compliance objectives
• Utilizes a matrix management approach to oversee a limited project portfolio negotiating resources and fostering efficiency in timelines budgets and team development
• Leads contract reviews with third-party partners manage project budgets with ADT collaboration and ensure successful CMC execution and quality deliverables within approved funding
• Guides CMC development teams by organizing meetings setting agendas highlighting achievements and risks and conducting reviews to efficiently meet phase transition criteria
• Advances corporate and divisional initiatives encourage creative and scientific thinking and champion quality and resource management.
• Develops updates and implements CMC product development plans while ensuring regulatory health safety and environmental compliance and support high-quality global filings approvals and product launches

Qualifications :

• Bachelors Degree with at least 18 years of CMC experience a Masters Degree with at least 16 years of relevant CMC experience or a PhD with at least 10 years of relevant CMC experience
• Strong educational foundation with significant experience across CMC functions
• Excellent scientific writing and verbal communication skills
• Expertise includes regulatory requirements and familiarity with relevant research instrumentation and techniques
• Solid knowledge of pharmaceutical sciences and the drug development process
• Interdisciplinary CMC experience and depth of expertise
• Negotiation influencing and leadership abilities are well developed
• Creative and entrepreneurial thinking to guide smart business decisions
• Fostering a high level of team morale within the CMC group

Additional Information :

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future
• We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees
• This job is eligible to participate in our short-term incentive programs
• This job is eligible to participate in our long-term incentive programs

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law. 

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

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Work :

No

Employment Type :

Full-time