Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) and Safety Standards

Job Description

Scientist – Packaging Development – Ware, UK

Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission – to enable our clients to make the world healthier, safer, and cleaner.

Within our Analytical Services team, we offer a functional service provider solution, which is an outstanding partnership that allows our customers to leverage our staff's experience while providing employees with direct onsite experience at a pharmaceutical/biopharmaceutical company, maintaining full-time benefits.

Summarized Purpose:

Essential Functions:

1. Support the delivery of the move to a newer vacuum decay process.
2. Test new bench top manufacturing equipment within the R&D packaging lab, experimenting with various blister materials.
3. Test the new seal integrity analysis equipment.
4. Identify ways of working, research, and compare standard test methodologies, and develop instructions for equipment use.
5. Lead the self-inspection audit schedule, respond to findings, communicate findings and good practices, and complete or assign related actions.
6. Record prior knowledge data from packaging development work packages.
7. Update specifications to ensure accuracy and proper references.
8. Develop packaging development strategies for bulk pack analysis, stability, and preferred components for drug substance and drug product.
9. Deliver sustainability assessments of different packaging container closure systems and New Product Introductions.
10. Conduct moisture modeling assessments of packaging systems and oral solid dose products, identifying required desiccant levels.
11. Act as the lead experimental scientist conducting laboratory investigations on developing coldform and thermoform blister foils.

Education and Experience:

• B.S./M.S. degree in Packaging Engineering/Science, Chemistry, Life Science, or equivalent industry experience.
• Proven experience in pharmaceutical packaging development.

Knowledge, Skills, and Abilities:

• Understanding of design control requirements for Medical Devices and Combination Products.
• Knowledge of pharmaceutical packaging, technology, regulatory requirements, R&D, NPI, and technology transfer processes.
• Proven track record of project delivery within complex, multidisciplinary teams across organizational and cultural boundaries.
• Ability to manage multiple projects and meet milestones.
• Working knowledge of packaging materials, components, vendors, equipment, legislation, regulations, and technologies.
• Knowledge of domestic and international packaging regulations (FDA, MAA, USP, Ph. Eur., etc.).
• Understanding of statistical analysis and Design of Experiments applied to packaging operations.

Our 4i Values:

Integrity – Innovation – Intensity – Involvement

If you resonate with our values and wish to contribute to delivering safe and effective therapeutics for urgent health needs, we encourage you to submit your application. We look forward to hearing from you.