Senior Scientist (all genders) Product Development Science & Technology - Global Material and Parenteral Packaging (permanent / full- or part-time)

Unternehmensbeschreibung

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 Twitter, Facebook, Instagram, YouTube and LinkedIn.

Stellenbeschreibung

The job that makes possibilities real in patients' lives. And yours.

The job that helps you get ahead in life. Moving mountains together.

Welcome to AbbVie! As part of an international company with 48,000 employees worldwide and around 3,000 employees in Germany, you will have the opportunity of addressing some of tomorrows unmet medical needs in close collaboration with your colleagues. Are you passionate about improving global health care? Do you want to contribute to improving patients' quality of life through your expertise? In a challenging work environment that offers opportunities of developing and increasing your own skills? Youve come to the right place!

Moving mountains together – as Senior Scientist (all genders) Product Development Science & Technology - Global Material and Parenteral Packaging (permanent / full- or part-time)

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.

Responsibilities

• 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 Life-Cycle-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