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 products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
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 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.
Job Description
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 attributesProvide 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 (e.g. identify cost saving opportunities, evaluating new suppliers, implementing changes to components and technology improvements)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 systemsLead CCS related technical impact assessment for investigations, complaints and change controlRepresent the PDS&T group in cross-functional teams and develop strong cross-functional relationships with manufacturing, process development, quality functions, procurement and external partners to enable effective resolution to technical issues and drive continuous process improvement
Qualifications
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 fieldsExpert knowledge and practical experience in container closure system qualification, e.g. profound knowledge in CCS materials, E&L concepts, functional CCS characterization, Container Closure Integrity testingProfound knowledge of quality and regulatory requirements for container closure systems for parenteral pharmaceutical and biopharmaceutical products, primary packaging materials and drug/device combinations productsPractical experience and strong knowledge of Parenteral Fill finish processes is preferred and solid understanding of pharmaceutical development in a cGMP environmentStrong leadership skills, demonstrated through the successful establishment and management of cross-functional teams in a manufacturing setting. Additionally, demonstrate excellence in fostering a collaborative work environment, driving team performance, and supporting professional development to achieve strategic objectivesThe 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 multi-disciplinary teams; must be attentive to details and have excellent organization skillsExcellent interpersonal skills with the ability to interact professionally and effectively with peers, management, and leadership both within and outside AbbVieExcellent oral and written communication skills including the ability to create sound technical documents
Additional Information
Here's how we can grow together:
with a diverse work environment where you can have a real impactwith an open corporate culturewith an attractive salarywith an intensive onboarding process with a mentor at your sidewith flexible work models for a healthy work-life balancewith a corporate health management that offers comprehensive health and exercise programswith company social benefitswith a wide range of career opportunities in an international organizationwith top-tier, attractive development opportunitieswith 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.
Any questions? Feel free to email us at TalentAcquisition.de@abbvie.com – we look forward to hearing from you!
AbbVie 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 https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html