Associate DirectorDirector CMC Product Development all genders fulltime permanent

More than a job. It\’s a chance to make a real difference.

At AbbVie, we strive to push the boundaries of science and innovation to improve life quality globally. As part of our vibrant team, you\’ll help transform possibilities in neurological and psychiatric care into realities. Join a global powerhouse with over 50,000 employees worldwide, including 3,000 in Germany, where your expertise will address tomorrow\’s unmet medical needs.

Position: Associate Director / Director, CMC Product Development

This role involves independently managing programs of various complexities using a matrix approach. You will lead Chemistry Manufacturing and Controls (CMC) teams and Product Presentation and Device Strategy Teams (PPDST) comprising cross-functional representatives from various departments. Your responsibilities include creating CMC strategies, development plans, and ensuring alignment with overarching asset strategies to meet key milestones. You will serve as the spokesperson for CMC functions, ensuring effective communication among teams and stakeholders, and collaborate with clinical, regulatory, operational, quality, preclinical, safety, ADME, and commercial organizations.

Key Responsibilities:

1. Represent CMC in Asset Strategy Teams: Serve as the spokesperson for CMC projects, ensure quality and compliance, participate in regulatory meetings, and develop development plans with timelines and risk mitigation strategies.
2. Lead CMC and PPDST Teams: Schedule meetings, develop agendas, identify risks, and oversee project reviews to meet phase transition criteria, including for NCEs, NBEs, ADCs, toxins, and gene and cell therapies.
3. Manage Contracts and Budgets: Review contracts, develop budgets, coordinate with external partners, and oversee outsourcing agreements and SOWs.
4. Partner with External and Internal Stakeholders: Lead due diligence, licensing opportunities, and program transitions, ensuring resource allocation and project progression.
5. Oversee Project Management: Manage multiple projects, negotiate resources, influence timelines, and implement resource-efficient strategies. Provide feedback for team development.
6. Align with Development Functions: Ensure strategic coordination with preclinical toxicology, biological sciences, QTAS, ADME, and other key functions to meet asset development milestones.
7. Ensure Regulatory Compliance and Communication: Maintain compliance with global regulatory standards, prepare dossiers, and communicate with health authorities.

Qualifications:

• Bachelor\’s Degree with 10+ years, Master\’s with 8+ years, or PhD with 6+ years of relevant experience in CMC or related functions. Overall 26+ years of industry experience preferred.
• Excellent scientific writing and verbal communication skills.
• Strong knowledge of regulatory requirements and scientific instrumentation.
• Deep understanding of pharmaceutical drug development and interdisciplinary CMC expertise.

Desired Skills:

• Negotiation, influencing, and leadership skills.
• Entrepreneurial mindset and strategic decision-making abilities.
• Ability to foster high morale and collaboration in cross-functional teams.

What We Offer:

• A diverse work environment with impactful roles.
• An open corporate culture and attractive salary.
• Structured onboarding with mentoring.
• Flexible work models for work-life balance.
• Comprehensive health and wellness programs.
• Global career development opportunities and an international network.

We are proud to be recognized as a Great Place to Work and are committed to diversity, equity, and inclusion. We focus on environmental and social responsibility and value all employees\‘ dignity and respect.

We invite applications for the role of Executive Director, Neuroscience Discovery, based in Ludwigshafen. Join us to lead groundbreaking research and innovation. Submit your CV to start your journey with AbbVie.

Additional Information:

AbbVie is an equal opportunity employer committed to integrity, innovation, and community service. We welcome applicants from all backgrounds, including veterans and individuals with disabilities.

For US & Puerto Rico applicants, please visit our website for more information and accommodation requests.

Employment Type: Full-time

Key Skills: Fundraising, Management, Biotechnology, Clinical Development, Research & Development, Leadership, Public Speaking, Product Development

Experience: 26+ years in related roles

Vacancy: 1

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