Principal Research Scientist, Material and Parenteral Packaging -(Onsite, IL based)

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.

Job Description

We are seeking a Principal Research Scientist to be a key contributor within our Global Material and Parenteral Packaging Science team within Product Development Science & Technology (PDS&T), offering advanced technical expertise in the field of CCS and combination products. This role demands leadership in the development of CCS for primary packaging systems and collaboration with manufacturing and device teams to ensure successful development and commercialization of the drug product.

As a vital contributor to regulatory success, the Principal Research Scientist will provide sterile packaging technical support for quality and regulatory activities, encompassing the preparation of technical documentation for regulatory submissions. 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.

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 and the commercial product.

Responsibilities

• 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 sterile packaging technical assistance for quality and regulatory activities including preparation of technical documents for regulatory filings.

• Partner with device development team to ensure system level requirements for combination products are developed, verified, and validated in accordance with design controls

• Develop strong cross-functional relationships with manufacturing, process development, Quality Control and Quality Assurance to enable effective resolution to technical issues and drive continuous process improvement.

• Evaluate and develop new materials and/or alternate packaging materials, packaging solutions or packaging systems, focused on sterile dosage forms, based on patient, user, and technical requirements.

• Expert knowledge in container closure system qualification, in-depth knowledge of regulatory requirements for container closure integrity, hands-on experience in container closure integrity test method development and validation.

• Excellent interpersonal skills with the ability to interact professionally and effectively with peers, management, and leadership both within and outside AbbVie.

• Excellent oral and written communication skills including the ability to create sound technical documents.

Qualifications

• MS or Diploma (14+ years) or PhD degree (8+ years) in Analytical Chemistry, Material Sciences, Chemistry, Physic, or related fields, preferably with PhD degree.

• Expert knowledge in parenteral manufacturing or CCS development in either pharmaceutical, medical device or biotech industry is required.

• Profound knowledge in E&L concepts, functional CCS characterization and Container Closure Integrity testing and assessment.

• Experience in analytical method development and validation according to USP, ICH or other compendial or regulatory requirements.

• Knowledge around regulatory requirements for parenteral pharmaceutical and biopharmaceutical products, packaging materials and drug/device combinations products expected.

• Strong 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 objectives

• 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 multi-disciplinary teams; must be attentive to details and have excellent organization skills

• Excellent oral communication skills as well as sound technical writing and documentation competencies are required.

Additional Information

Applicable only to applicants