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.
• Serves as the spokesperson for all CMC functions and ensures information flow among AST and various line functions.
• 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).
• Partners with key collaborators, incl. Clinical, Regulatory, Operations, Quality, Preclinical Safety, ADME and Commercial organizations.
• 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

• For Director, CMC Product Development:
  • Bachelors Degree with at least 12 years of experience in a variety of relevant functions required;
  • Masters Degree with at least 10 years of relevant experience required;
  • or PhD with at least 8 years of relevant experience required.
• For Associate Director, CMC Product Development:
  • Bachelors Degree with at least 10 years of experience in a variety of relevant functions required;
  • Masters Degree with at least 8 years of relevant experience required;
  • or PhD with at least 6 years of relevant experience required.
• 3-8 years of working experience required in the same/similar role or in related CMC function.
• Must possess excellent scientific writing and verbal communication skills.
• Must have a good working knowledge of regulatory requirements and familiarity with relevant scientific instrumentation and techniques.
• Deep knowledge of pharmaceutical drug development process.
• Possess negotiating, influencing, leadership skills.
• Creative in implementing entrepreneurial thinking and making smart business decisions.
• Ensure high level of morale and collaboration in cross-functional teams to maximize team impact and output.

Additional Information

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.

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