AbbVie Deutschland GmbH & Co. KG

AbbVie's Product Development Science & Technology (PDS&T) organization is seeking a highly motivated, talented, and creative Principal Research Scientist I to be a key contributor within our Global Material and Parenteral Packaging Science team within PDS&T, offering advanced technical expertise in the field of Container Closure Systems (CCS), parenteral manufacturing and combination products.

This role demands leadership in the development and life cycle for primary packaging components and collaboration with manufacturing, quality, procurement, development, device teams and external partners to ensure successful development and commercialization of the drug product.

In your role as technical expert for CCS you will work collaboratively with experts in global multi-functional teams and serve as Technical Lead on your own projects and contribute CCS insights into multiple other projects from early development through to product launch, technical commercial support and life cycle management.

As Technical Lead you will:

- Deliver technical expertise in the development of container closure systems, including vials, prefilled syringes, and prefilled cartridges, by employing cutting-edge methodologies to conduct comprehensive analyses and evaluations of their protection, safety, compatibility, and performance attributes
- Provide technical leadership of primary packaging selection and qualification for sterile dosage forms, development of specifications for primary packaging components, internal/external tech transfer and life cycle management for commercial products
- Additionally, the role requires partnering with device development teams to ensure that system-level requirements for combination products are meticulously developed, verified, and validated in alignment with design controls.
- Support continuity of supply for marketed products and ensure technical performance, processability and safety of the primary packaging components and systems
- Lead CCS related technical impact assessment for investigations, complaints and change control

Qualifications

This is how you make a difference:

- M.Sc. or Diploma (and 12+ years) or PhD degree (and 6+ years) in Parenteral manufacturing, Parenteral process development, Container closure and combination product development, Product Quality, Analytical, Material Sciences, or related fields
- Expert knowledge and practical experience in container closure system, e.g. profound knowledge in CCS materials, E&L concepts, functional CCS characterization, Container Closure Integrity testing
- Profound knowledge of quality and regulatory requirements for container closure systems for parenteral pharmaceutical and biopharmaceutical products, primary packaging materials and drug/device combinations products
- Practical experience and strong knowledge of Parenteral Fill finish processes is preferred and solid understanding of pharmaceutical development in a cGMP environment
- Strong leadership and communication skills, demonstrated through the successful establishment and management of cross-functional teams in a manufacturing setting
- The candidate must have strong analytical and problem solving skills and be able to work independently, respond to changing priorities and short lead times for multiple tasks

Additional Information

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