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Director, CMC Product Development - Lincoln, United States - Allergan
Description
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 Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.Job Description
Leads global Product Presentation and Device Strategy Teams (PPDST) and Chemistry, Manufacturing and Controls (CMC) teams of functional representatives from various departments and divisions.
Accountable for creating a CMC development plan in collaboration with line functions and the Asset Strategy Team (AST).Serves as the spokesperson for all CMC functions and ensures information flow among AST and various line functions and stakeholders.
Partners with Clinical, Regulatory, Operations, Quality, Preclinical Safety, and Commercial organizations. Apprises CMC and Stakeholder Management of strategies, plans and risks through regular communications and periodic reviews throughout development and in support of global filings and approvalsRepresents all CMC areas on the AST serving as spokesperson for the CMC project team and ensures information flow among the AST 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.Leads the Product Presentation and Device Strategy Team (PPDST), a key deliverable team of the AST. Develops an integrated CMC strategy considering value drivers incl. patient convenience
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.
Leads several early stage projects and one or more late stage projects in one modality area (NBE, NCE, gene/cell therapy) using 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 achieves 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 AST, 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.
Promotes scientific and entrepreneurial thinking, encourage creativity and manage quality and results with respect to science, time, budget and resources.
Develops and implements a CMC product development plan and updates as necessary in collaboration with the ADT and respective line functions.
Apprises CMC Management of plans and risks through regular communications and periodic reviews throughout development and in support of global filings, approvals and launches.
Responsible for the Quality / Module 3 content of global filings of high quality CMC dossiers, approvals and commercialization of products.
Qualifications - External
Bachelor's Degree with at least 10 years of experience in a variety of CMC functions required; Master's Degree with at least 8 years of relevant CMC experience required; or PhD with at least 6 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.
Excellent communication, leadership and influencing skills, superior team building skills in a matrixed environment.Must possess superior scientific writing skills.
Must have a good working knowledge of regulatory requirements and familiarity with relevant research instrumentation and techniques.
Expert knowledge of pharmaceutical sciences and the drug development process.
Must have CMC interdisciplinary experience and expertise.
Creative in implementing entrepreneurial thinking and make smart business decisions. Excels in agility, accountability and motivation
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 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 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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