Senior Director, Cmc Product Development

Company DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job DescriptionThe Senior Director of CMC Product Development will use their breadth of experience to drive best-in-class drug product development strategies in support of AbbVie's pipeline. This role will include personal leadership on key pipeline projects while also supervising and mentoring a team of CMC Product Development Directors.
A key function of the role is to serve as a member of the Asset Strategy Team (AST) and ensure the Product Presentation & Device Strategy Team (PPDST) and CMC development plans closely align with the clinical and regulatory development strategy. This requires leading global teams of functional representatives from various departments and divisions as well as creating the Product Presentation & Device Strategy Team (PPDST) strategy and CMC development plan in collaboration with line functions and the AST.
The successful candidate will have the ability to develop and implement project management tools and training to ensure consistency and quality of team deliverables. A background leading Chemistry, Manufacturing, and Controls (CMC) aspects of drug/combination products on multiple programs is essential.
Responsibilities:
Represents all CMC areas on the AST serving as spokesperson for the PPDST and CMC project teams and ensures information flow among the AST and all line functions. Participates in meetings with Regulatory Authorities, responds urgently to regulatory queries, and participates in Pre-Approval Inspections.Critically evaluates and integrates drug substance, drug product, and device inputs to PPDST and 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.Lead several late-stage programs across several modalities, incl. NCE, NBE, device/combination product, gene therapy, cell therapies.Promotes entrepreneurial thinking and makes smart business decisions while balancing risk.Manages multiple PPDST and 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 AbbVie's Program Management framework for asset development, including initiatives to drive continuous improvement of the Pipeline Commercialization Model and Governance, incl. TASC, CMC GR, EPG/LMG etc. and effectively collaborates 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.Supervises or mentors junior colleagues and Peers to drive individual and organizational growth.Leads PPDST and CMC development teams for assigned projects: schedules meetings, develops agendas, issues highlights, apprise risks and plans with CMC Management and management of partner functions across organizations, conducts periodic reviews, to ensure that deliverables are met at each stage gate in the most efficient and resource sparing manner.Apprises Development Sciences and Ops/CMC and partner function Management of plans and risks through regular communications and periodic reviews throughout development and in support of global filings, approvals and launches. QualificationsBachelor's Degree with at least 10 years of experience in a variety of CMC functions required; Master's 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. Experience across various asset modalities, e.g. NCE, NBE, gene/cell therapy and device development desirable.Possess negotiating, influencing, leadership skills.Creative in implementing entrepreneurial thinking and make smart business decisions.Ensure high level of morale in the CMC team.Ability to be based from AbbVie's headquarters in North Chicago, IL. Additional InformationApplicable 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 Company's sole and absolute discretion unless and until paid and may be modified at the Company's 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 AbbVie's 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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