Senior Scientist (all genders) Product Development Science & Technology - Global Material and Parenteral Packaging (permanent / full- or part-time)
Ludwigshafen am Rhein
Aktualität: 27.12.2024
27.12.2024, AbbVie Deutschland GmbH & Co. KG
Ludwigshafen am Rhein
Senior Scientist (all genders) Product Development Science & Technology - Global Material and Parenteral Packaging (permanent / full- or part-time)
Aufgaben:
We are seeking a Senior Scientist to support the Global Material and Parenteral Packaging Science team within Product Development Science & Technology (PDS&T).
Direct project activities regarding Container Closure System (CCS) development for AbbVie's early- and late-stage parenteral Antibodies, Antibody-Drug Conjugates as well as Eye Care and Neurotoxin products. Independently conceive, develop, and manage all aspects of CCS landscaping and characterization for Vials, Prefilled Syringes (PFS) and Cartridges to support drug product and combination products requirements.
In your role as technical expert for CCS you will work collaboratively with experts in multi-functional teams and serve as Technical Lead on his/her own project and contribute CCS insights into multiple other projects from early development through to product launch, technical commercial support and life cycle management.
The candidate will be working on the development of container closure systems (CCS) and manufacturing processes within the PDS&T organization at AbbVie.
Lead, design, and evaluate the development of innovative and/or alternate primary packaging materials, packaging solutions or packaging systems for sterile dosage forms
Provide technical leadership of primary packaging selection and qualification, development of component specification for primary packaging components, support internal / external tech transfer and Lifecycle-Management (LCM) for commercial products (e.g. identify cost saving opportunities, evaluating new suppliers, implementing changes to components and technology improvements)
Support continuity of supply for marketed products and ensure technical performance, processability and safety of the primary packaging components and systems, i.e. regulatory questions, support complaint investigations and change control
Represent the PDS&T group in cross-functional teams and develop strong cross-functional relationships, proven ability to work collaboratively in cross-functional teams located globally, and effectively communicate complex packaging concepts to stakeholders at various levels
Partner with device / combination product development teams to ensure system level requirements for combination products are developed, verified, and validated in accordance with design controls requirements
Qualifikationen:
Senior Scientist II: Bachelor's Degree or equivalent education and typically, 12 years of experience, master's degree or equivalent education and typically 10 years of experience, PhD and typically 4 years of experience. Degree in Pharmaceutical Technology, Analytical Chemistry, Material Sciences, Chemistry, Physic, or related fields
Senior Scientist I: Bachelor's Degree or equivalent education and typically, 10 years of experience, master's degree or equivalent education and typically 8 years of experience, PhD and some necessary experience. Degree in Analytical Chemistry, Material Sciences, Chemistry, Physic, or related fields
Significant experience in primary packaging development, qualification and implementation within the pharmaceutical industry, including experience working in a GMP environment, preferably in sterile / aseptic fill & finish
In-depth knowledge of primary packaging materials, CCS, combination products and relevant regulatory requirements (e.g., FDA, EMA, ISO etc.)
Able to mentor and guide a team of scientists
Excellent oral communication skills as well as sound technical writing documentation competencies are required, experience in authoring and reviewing regulatory submissions
The candidate must be able to work independently, respond to changing priorities and short lead times for multiple tasks; able to identify problems and work toward solutions; able to influence without direct authority in multidisciplinary teams; must be attentive to details and have excellent organization skills and the ability to make informed decisions based on scientific data and risk assessment
Fluent in written and spoken English