Associate Director / Director, CMC Product Development

About the role

This role can be hired at either level dependent upon years of experience and education.

Responsibilities

• Represents 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 certifies compliance with global regulatory and quality requirements.
• Participates in meetings with Regulatory Authorities, responds to regulatory queries, and participates in communications and meetings with regulatory agencies.
• Accountable for creating CMC development plan incl. timelines, risks and mitigations in collaboration with line functions and AST
• Leads PPDST and/or CMC development teams for assigned projects: schedules meetings, develops agendas, issues highlights, identifies risks and develops mitigation plans with technical functions.
• Conducts periodic reviews to ensure that phase transition criteria are met in the most efficient and resource effective manner.
• Reviews contracts with Third Party Manufacturers and consultants.
• Develops budget needs in collaboration with AST, obtains resources from functional areas and stays within the approved funding.
• Drives legal and financial aspects of outsourcing, contracts, and statements of work (SOW).
• Serves as the spokesperson for all CMC functions and ensures information flow among AST and various line functions and stakeholders.
• Partners with key collaborators, incl. Clinical, Regulatory, Operations, Quality, Preclinical Safety, ADME 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 approvals.
• Serves as the spokesperson for all CMC functions and ensures information flow among AST and various line functions and stakeholders.
• Supports and implements corporate and division-level initiatives and strategies.
• Promotes scientific and entrepreneurial thinking, encourages creativity and manages quality and results with respect to science, time, budget and resources.
• Mentors PDD peers and/or other less experienced team members.
• Responsible for performance and career development of 0-3 direct reports.
• Ensures compliance with regulatory, health, safety and environmental requirements.
• Stays abreast of developments in global technical, regulatory and compliance arena and industry practice.
• Apprises management of plans and risks through regular communications, periodic reviews, in support of global filings, approvals and general agency feedback.
• Responsible for the quality and effectiveness of dossiers and communication with health authorities at global level.

Qualifications

• Director, CMC Product Development: Bachelor’s Degree with at least 12 years of experience in a variety of relevant functions required; Master’s Degree with at least 10 years of relevant experience required; or PhD with at least 8 years of relevant experience required. 3-8 years of working experience required in the same/similar role or in related CMC function.
• Associate Director, CMC Product Development: Bachelor’s Degree with at least 10 years of experience in a variety of relevant functions required; Master’s Degree with at least 8 years of relevant experience required; or PhD with at least 6 years of relevant experience required. 2-6 years of working experience required in the same/similar role or in related CMC function.

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 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 and serving our community.
• Equal Opportunity Employer/Veterans/Disabled.
• US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
• US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html