Drug Product Lead fulltime

Overview

Abb Vie'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 products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit  Follow @abbvie on X, Facebook, Instagram, You Tube, Linked In and Tik Tok.

You will lead and represent the Drug Product (DP) team for a product and be responsible for defining and executing the activities of drug product development, lifecycle management, and the technical-scientific support of the commercial production according to the latest state of science and technology, while considering regulatory requirements for the manufacturing of pharmaceuticals in parenteral drug product development.

• Lead and represent the Drug Product (DP) team for a late-stage development and or a commercial product
• Drive Tech Transfers to commercial DP manufacturing sites
• Provide technical leadership in exception and change management
• Represent manufacturing, CCS and Formulation aspects in the PDS&T CMC Team
• Develop, manage and drive execution of global initiatives to improve biologics CMC drug product development and commercial support strategies
• Review and approve of GMP-compliant and regulatory documents (such as IMPD, IND, CTD for clinical trials, and BLA, NDA, PAS for market submissions)
• Communicate actively project strategies, key issues and risks to the PDS&T CMC
  - Team, to functional management and SMEs as well as present complex technical topics to the development team and management

• You are a Pharmacist, Chemist, Biochemist, Biologist or have comparable academic background, preferably with PhD and typically 4 years of experience in relevant areas of parenteral Drug Products or Master Degree or equivalent education and typically 10 years of experience.
• Proven track-record of advanced technical/scientific achievements.
• Practical experience with process transfers from R&D to Operations is desirable.
• You are used to working in a fast-paced, collaborative environment overseeing multiple concurrent projects. You have thorough understanding of Global CMC drug development, strong project management skills, and long-term planning skills.
• You are experienced with working in a cGMP-regulated environment, including knowledge of international relevant (especially US/EU) regulatory and quality requirements and standards.
• You have strong leadership skills:
  Proven track-record in successful direct or cross-functional people management while effectively working in matrix organisations.

• Here s how we can move mountains together:
• with a diverse work environment where you can have a real impact
• with an open corporate culture
• with an attractive salary
• with an intensive onboarding process with a mentor at your side
• with flexible work models for a healthy work-life balance
• with a corporate health management that offers comprehensive health and exercise programs
• with company social benefits
• with a wide range of career opportunities in an international organization
• with top-tier, attractive development opportunities
• with a strong international network

Multiple times, we have been globally recognized as a "Great Place to Work" and we are proud to provide our employees with the flexibility to maintain a healthy work-life balance. We take our impact on the environment and our communities seriously and therefore focus on giving something back on a regular basis. We are committed to equality, equity, diversity and inclusion (EED&I) - 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 Abb Vie, 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.

Abb Vie 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

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