Principal Research Scientist Global Material and Parenteral Packaging Sciences -( On site, IL based)

ZipRecruiter; North Chicago (IL); On-site; USD 100,000 - 130,000; Full time

Job summary

A leading company in the pharmaceutical industry is seeking a Principal Research Scientist to contribute to the development of container closure systems and ensure regulatory success. The role involves collaboration with cross-functional teams and requires expertise in analytical chemistry and packaging solutions.

Benefits

Paid Time Off

Medical/Dental/Vision Insurance

401(k)

Short-term and Long-term Incentive Programs

Qualifications

• 14+ years with MS or Diploma, or 8+ years with PhD in relevant fields.
• Expert knowledge in parenteral manufacturing or CCS development.

Responsibilities

• Deliver technical expertise in the development of container closure systems.
• Provide sterile packaging technical assistance for regulatory activities.
• Evaluate and develop new materials for sterile dosage forms.

Skills

Leadership

Analytical Skills

Communication

Education

MS or Diploma in Analytical Chemistry

PhD in Chemistry or related fields

Job description

Job Description

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 TikTok.

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, including 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 a technical expert for CCS, you will work collaboratively with experts in multi-functional teams, serve as Technical Lead on your own projects, and contribute CCS insights into multiple other projects from early development through to product launch and the commercial product.

Responsibilities

1. 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.
2. Provide sterile packaging technical assistance for quality and regulatory activities, including the preparation of technical documents for regulatory filings.
3. Partner with device development teams to ensure system-level requirements for combination products are developed, verified, and validated in accordance with design controls.
4. Develop strong cross-functional relationships with manufacturing, process development, Quality Control, and Quality Assurance to enable effective resolution of technical issues and drive continuous process improvement.
5. 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.
6. Provide expert knowledge in container closure system qualification, in-depth knowledge of regulatory requirements for container closure integrity, and hands-on experience in container closure integrity test method development and validation.
7. Demonstrate excellent interpersonal skills to interact professionally and effectively with peers, management, and leadership within and outside AbbVie.
8. Exhibit excellent oral and written communication skills, including the ability to create sound technical documents.

Qualifications

1. MS or Diploma (14+ years) or PhD degree (8+ years) in Analytical Chemistry, Material Sciences, Chemistry, Physics, or related fields, preferably with a PhD degree.
2. Expert knowledge in parenteral manufacturing or CCS development in pharmaceutical, medical device, or biotech industries.
3. Profound knowledge in E&L concepts, functional CCS characterization, and Container Closure Integrity testing and assessment.
4. Experience in analytical method development and validation according to USP, ICH, or other regulatory requirements.
5. Knowledge of regulatory requirements for parenteral pharmaceutical and biopharmaceutical products, packaging materials, and drug/device combinations.
6. Strong leadership skills demonstrated through managing cross-functional teams in a manufacturing setting, fostering collaboration, and driving team performance.
7. Ability to work independently, respond to changing priorities, identify problems, influence without authority, and organize effectively.
8. Excellent oral communication and technical writing skills.

Additional Information

Applicable only to applicants applying to a position in locations with pay disclosure requirements:

• The compensation range is a good-faith estimate based on the job grade, and actual pay may vary depending on location and other factors.
• We offer comprehensive benefits including paid time off, medical/dental/vision insurance, and 401(k).
• This role is eligible for short-term and long-term incentive programs.

Note: Compensation is only considered earned when vested and payable. The company reserves the right to modify compensation and benefits at its discretion.

AbbVie is an equal opportunity employer committed to integrity, innovation, and community service. We welcome applications from veterans and individuals with disabilities.

US & Puerto Rico only - learn more at https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html. For accommodations, visit https://www.abbvie.com/join-us/reasonable-accommodations.html.