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

Company Description

AbbVie’s mission is to discover and deliver innovative medicines and solutions 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, and eye care—and portfolio products and services in our Allergan Aesthetics division.

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Job Description

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

At AbbVie, we push the boundaries of science and innovation to improve life quality globally. As part of our vibrant team, you will 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.

As an Associate Director/Director, CMC Product Development, you independently manage programs of varying complexity using a matrix approach. You 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 the Pipeline Commercialization Model (PCM). In the role of PPDST co‑chair for Asset Strategy Teams (ASTs) and a key member of AST, you are accountable for creating a CMC strategy and development plan that aligns with the overarching asset strategy to advance to the next key milestone and deliver a differentiated product.

You serve as the spokesperson for all CMC functions and ensure information flow among AST and various line functions and stakeholders. You also partner with key collaborators—including Clinical, Regulatory, Operations, Quality, Preclinical Safety, ADME and Commercial organizations—to communicate strategies, plans and risks through regular communications and periodic reviews throughout development and in support of global filings and approvals. In addition, you support and implement CMC functional initiatives across‑asset strategies.

Make your mark by:

• Representing all CMC areas on the AST, serving as spokesperson for the CMC project team and ensuring information flow among the AST and all line functions. Ensuring high‑quality science, technology, deliverables, and certifying compliance with global regulatory and quality requirements; participating in meetings with Regulatory Authorities, responding to regulatory queries, and engaging in communications and meetings with regulatory agencies.
• Leading PPDST and/or CMC development teams for assigned projects: scheduling meetings, developing agendas, issuing highlights, identifying risks and developing mitigation plans with technical functions. Conducting periodic reviews to ensure phase transition criteria are met efficiently and resource‑effectively. Asset modalities may include NCEs, NBEs, ADCs, toxins, and gene and cell therapies.
• Reviewing contracts with Third‑Party Manufacturers and consultants; developing budget needs in collaboration with AST, obtaining resources from functional areas and staying within approved funding. Driving legal and financial aspects of outsourcing, contracts and statements of work (SOW). Demonstrating excellent interpersonal skills, ability to build relationships with external partners and key internal stakeholders, and strong negotiating, influencing and leadership skills.
• Leading teams and partner interactions for new due diligence in‑licensing opportunities and successfully transitioning leadership for programs that are internalized.
• Managing a limited number of projects of varying complexity using a matrix management approach. Negotiating additional resources when required, influencing project timelines to ensure proper completion of required activities, and implementing creative approaches to conserve resources, achieve time and budget efficiency, and identify team growth needs.
• Ensuring strategic alignment with other key Development Sciences functions, such as Preclinical Toxicology/Biological Sciences and QTAS/ADME, to meet key deliverables for asset advancement and maintain risk and mitigation plans. Integrating and implementing pre‑clinical development plans and updates in collaboration with global development teams and line functions.
• Supporting and implementing CMC functional initiatives and across‑asset strategies.
• Promoting scientific and entrepreneurial thinking, encouraging creativity, and managing quality and results with respect to science, time, budget and resources.
• Ensuring compliance with regulatory, health, safety and environmental requirements and staying abreast of developments in global technical, regulatory and compliance arenas and industry practice.
• Apprising management of plans and risks through regular communications and periodic reviews to support global filings, approvals and general agency feedback; responsible for the quality and effectiveness of dossiers and communication with health authorities at the global level.

Qualifications

• Bachelor’s Degree with at least 10 years of experience in a variety of relevant functions; Master’s Degree with at least 8 years of relevant experience; or PhD with at least 6 years of relevant experience.
• 2–6 years of working experience in the same or related CMC function.
• Excellent scientific writing and verbal communication skills.
• Good working knowledge of regulatory requirements and familiarity with relevant scientific instrumentation and techniques.
• Good knowledge of pharmaceutical drug development process.
• Must have CMC interdisciplinary experience and expertise.
• 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.

What we offer you:

• Diverse work environment where you can have a real impact.
• Open corporate culture.
• Attractive salary.
• Intensive onboarding process with a mentor at your side.
• Flexible work models for a healthy work‑life balance.
• Corporate health management offering comprehensive health and exercise programs.
• Company social benefits.
• Wide range of career opportunities in an international organization.
• Top‑tier, attractive development opportunities.
• Strong international network.

Additional Information

Multiple times, AbbVie has been globally recognized as a “Great Place to Work” and we provide employees with the flexibility to maintain a healthy work‑life balance. We take our impact on the environment and our communities seriously and focus on giving something back on a regular basis.

We are committed to equality, equity, diversity and inclusion (EEDI) – a commitment that is fundamental to us. This includes appreciating different perspectives, creating an inclusive culture and treating all employees with dignity and respect.

At AbbVie, your individual contributions count—help us move mountains together. Be a part of our success, grow with us and accomplish more than you could have imagined. Sounds like the perfect career opportunity for you? We look forward to receiving your application! All you need is a complete CV – we will discuss everything else with you in person.

Equal Opportunity Employer

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our communities. Equal Opportunity Employer, Veterans, Disabled.

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