Senior Director CMC Product Development

Purpose:

Drive bestinclass drug product development strategies to support AbbVies pipeline through leadership on own projects and by supervising or mentoring other CMC Product Development Directors (PDDs). Develops and implements project management tools and develops training to assure consistency and quality of CMC Team deliverables. Manages CMC aspects of drug/combination product development on multiple programs. Key member of Asset Development Team (ADT) and ensures CMC strategy is closely aligned with the clinical and regulatory development strategy. Leads a global CMC team of functional reps from various departments. Accountable for creating CMC development plan in collaboration with line functions and ADT. Serves as spokesperson for all CMC functions and ensures information flow among ADT/ALB and line functions. Apprises CMC Mgmt of strategies plans and risks through regular communications and periodic reviews throughout development and in support of global filings and approvals.

Responsibilities:

• 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. Participates in meetings with Regulatory Authorities responds urgently to regulatory queries and participates in PreApproval Inspections.
• Critically evaluates and integrates drug substance drug product and device inputs to CMC team strategies and plans that align with corporate business objectives. Decisionmaking 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.
• Promotes entrepreneurial thinking and makes smart business decisions while balancing risk.
• Manages multiple CMC project teams and contributes to project prioritization on a portfolio level. 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.
• Supports and contributes to the strategic direction of AbbVies Program Management framework for asset development including initiatives to drive continuous improvement of the Pipeline Operating Model and Governance and effective collaboration across partner organizations.
• 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.
• Reviews contracts with external partners and consultants. Accountable for the success and overall CMC quality of a given project. Ensures timely 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 deliverables are met at each stage gate in the most efficient and resource sparing manner.
• Apprises CMC Management of plans and risks through regular communications and periodic reviews throughout development and in support of global filings approvals and launches.

Qualifications :

*This position will be required to sit onsite from our North Chicago IL headquarters*

Qualifications:

• Bachelors Degree with at least 10 years of experience in a variety of CMC functions required; Masters Degree with at least 10 years of relevant CMC experience required; or PhD with at least 10 years of relevant CMC experience required to effectively manage global teams and all CMC activities with respect to science technology quality regulatory/compliance requirements budget and resources.
• Multiple product development experiences of leading a CMC team through IND and NDA/MAA preferred.
• 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 sciences 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.

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 shortterm incentive programs. 

• This job is eligible to participate in our longterm 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 serving our community and embracing diversity and inclusion.  It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race color religion national origin age sex (including pregnancy) physical or mental disability medical condition genetic information gender identity or expression sexual orientation marital status status as a protected veteran or any other legally protected group status.

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Work :

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