Technical Lead Container Closure Systems Fulltime

Overview

Company Description Abb Vie 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 key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit  Follow @abbvie on X, Facebook, Instagram, You Tube, Linked In and Tik Tok.

Job Description Abb Vie 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.

• 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

• 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

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range.
  
  This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our short-term incentive programs.

Note:

No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company s sole and absolute discretion unless and until paid and may be modified at the Company s sole and absolute discretion, consistent with applicable law

Abb Vie is an equal opportunity employer and is committed to operating with integrity, driving…