Associate Director/Director CMC Product Development (all genders) (fulltime, permanent)

Stellenbeschreibung

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 the 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

You will independently manage programs of various complexity utilizing a matrix approach. Lead Chemistry, Manufacturing and Controls (CMC) teams and Product Presentation and Device Strategy Teams (PPDST) of functional representatives from various departments and divisions for projects involving external collaboration partners per Pipeline Commercialization Model (PCM). As PPDST co-chair for Asset Strategy Teams (ASTs) and a key member of AST, you will be accountable for creating a CMC strategy and development plan that aligns with overarching asset strategy to effectively advance to next milestones and deliver differentiated products. You serve as the spokesperson for all CMC functions, ensuring information flow among AST, line functions, and stakeholders. Partner with Clinical, Regulatory, Operations, Quality, Preclinical Safety, ADME, and Commercial organizations. Keep CMC and Stakeholder Management informed of strategies, plans, and risks through regular communications and reviews. Support and implement CMC initiatives and cross-asset strategies.

Key Responsibilities:

• Represent all CMC areas on the AST, serve as spokesperson, ensure information flow, and certify compliance with global regulatory and quality standards. Participate in meetings with Regulatory Authorities, respond to queries, and communicate with agencies. Create CMC development plans including timelines, risks, and mitigations in collaboration with line functions and AST.
• Lead PPDST and/or CMC development teams for assigned projects, schedule meetings, develop agendas, identify risks, and develop mitigation plans. Conduct periodic reviews to meet phase transition criteria efficiently. Modalities include NCEs, NBEs, ADCs, toxins, and gene/cell therapies.
• Review contracts with Third Party Manufacturers and consultants. Develop budgets, acquire resources, and manage outsourcing, contracts, and SOWs. Demonstrate strong interpersonal, negotiating, influencing, and leadership skills.
• Lead teams and partner interactions for due diligence in-licensing opportunities and transition leadership for internalized programs.
• Manage projects of various complexity using a matrix management approach, negotiate resources, influence timelines, and implement resource-efficient strategies. Provide feedback and identify growth needs for team members.
• Ensure strategic alignment with Preclinical Toxicology, Biological Sciences, QTAS, and ADME to meet key asset development deliverables. Integrate and update preclinical development plans collaboratively.
• Support and implement CMC and cross-asset strategies, promote scientific and entrepreneurial thinking, and manage quality and results.
• Ensure compliance with regulatory, health, safety, and environmental standards. Stay updated on global technical, regulatory, and industry developments.
• Report plans and risks regularly to management, support global filings and approvals, and ensure high-quality dossiers and communication with health authorities.

Qualifications:

• Bachelor’s Degree with at least 10 years of relevant experience, or Master’s Degree with 8 years, or PhD with 6 years. 2-6 years in similar roles or CMC functions.
• Excellent scientific writing and verbal communication skills.
• Good knowledge of regulatory requirements and scientific instrumentation.
• Strong understanding of pharmaceutical drug development and CMC interdisciplinary expertise.
• Negotiating, influencing, and leadership skills.
• Creative entrepreneurial thinking and smart business decision-making.
• Ability to foster high morale and collaboration in cross-functional teams.

What we offer you :

• A diverse work environment with meaningful impact
• An open corporate culture
• Attractive salary and comprehensive onboarding with a mentor
• Flexible work models for work-life balance
• Health management programs
• Company social benefits and international career opportunities
• Top-tier development opportunities and a strong global network

We have been recognized multiple times as a "Great Place to Work". We are committed to equality, diversity, and inclusion, fostering an inclusive culture and respecting all employees.

At AbbVie, your contributions matter. Join us to make an impact, grow your career, and achieve more than you imagined. Interested? Submit your CV, and we will discuss the rest in person.

Additional Information

AbbVie is committed to equal opportunity employment, working with integrity, driving innovation, and serving our community. We value diversity and inclusion, respecting different perspectives and creating an inclusive environment.