Beschreibung
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 products and services in our Allergan Aesthetics portfolio.
Technical Lead Container Closure Systems (all genders)
REF: R00138102
AbbVie's Product Development Science & Technology ...
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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 products and services in our Allergan Aesthetics portfolio.
Technical Lead Container Closure Systems (all genders)
REF: R00138102
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
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
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 f...