Associate Director CMC Program Strategy
AbbVie's mission is to discover and deliver innovative medicines 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, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .
Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products - Imbruvica, Venclexta, and Empliciti - and a pipeline containing multiple promising new molecules that are being studied in nearly 200 clinical trials in 19 different types of cancer.
AbbVie is expanding its oncology hub on the West Coast, with three sites in the San Francisco Bay Area (Redwood City, South San Francisco, and Sunnyvale) focused on the discovery and development of novel oncology therapies. More than 1,000 AbbVie scientists, clinicians, and product developers with strong entrepreneurial roots work across these three sites. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. This position is based at AbbVie in Redwood City, CA location.
- Leads a global Chemistry, Manufacturing and Controls (CMC) team of functional representatives from various departments and divisions for projects involving external collaboration partners.
- Integrate CMC product development strategy and project plan with collaboration partner and internal cross-functional project team.
- To serve as a CMC spokesperson for all CMC functions and ensure information flow among Asset Strategy Team (AST) 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.
- Represents all CMC areas on the AST serving as spokesperson for the product presentation and device team (PPDST) and ensures information flow among the AST 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.
- Proficient with legal and financial aspects of outsourcing, contracts, and statements of work (SOW).
- Demonstrate excellent interpersonal skills, ability to develop important relationships with external collaboration partners and key internal stakeholders.
- Demonstrate strong negotiating, influencing, and leadership skills.
- Lead teams and partner interactions for new due diligence in-licensing opportunities and successfully transition leadership for programs where development is internalized.
- Manages a limited number of projects of low complexity 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.
- Provides feedback and input to functional managers and identify growth needs for team members.
- Reviews contracts with Third Party Manufacturers and consultants.
- Develops an often-significant 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.
- 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.
- Integrate 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 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.
- 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**
Significant Work Activities
Yes, 25 % of the Time
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.