Scientist: Steriles Packaging Development

at  Thermo Fisher Scientific

JOB DESCRIPTION

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 customers to make the world healthier, safer, and cleaner.
Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to demonstrate the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.

EDUCATION AND EXPERIENCE:

• Bachelor’s degree in Chemistry, Life Science, Packaging Engineering, Packaging Science, or related field and 2+ years of applicable experience
  In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

PREFERRED QUALIFICATIONS:

• Knowledge of parenteral packaging materials, components, vendors, analytical equipment, and technologies.
• Experience in sterile drug primary packaging development for large and small molecules including vial/stopper, pre-filled syringes, and cartridges presentations.
• Knowledge of domestic and international packaging requirements and regulations (i.e., current applicable FDA/MAA guidelines, USP/Ph Eur, etc).
• Knowledge of statistical analysis and Design of Experiments as they apply to packaging operations.
• Ability to quickly establish relationships with internal and external stakeholders.
• Strong time management / organizational skills.
• Evidence of team working skills and flexibility.

TASKS:

• Perform timely execution of lab based analysis, including experiment write up to support sterile primary package selection, integrity, stability, and lifecycle for the coordination and testing of samples
• Examples of analytical technique include extrusion force testing, stopper movement assessment, CCI capabilities including HeLD, Vacuum Decay, and headspace analysis
• Be a practical expert in a packaging/analytical technique relevant to a primary pack presentation, capable of training others in the technique and application
• Collaborate with the Lab Manager to maintain the License To Operate (LTO) status in the Lab – including equipment maintenance, documentation and coordination with vendors, management monitoring, and safety requirements
• Maintain packaging lab component and lab inventory, including ordering, receiving, and organization of lab space to enable dynamic, flexible laboratory workspace
• Prepare and communicate data summaries to relevant project team members

STRETCH TASKS:

• Writing work instructions, study protocol contribution
• Authoring/revising component specifications
• Supporting document and knowledge management

Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary and/or standing for typical working hours.
• Able to lift and move objects up to 25 pounds.
• Able to work in non-traditional work environments.
• Able to use and learn standard office equipment and technology with proficiency.
• May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities