Scientist II

at  Thermo Fisher Scientific

JOB DESCRIPTION

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. And you’ll have the opportunity for continual growth and learning in a culture that empowers your development. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.
The Technical Operations team is responsible for process validations and implementations, change control, technical transfer and technical support for ELISA kits. The Scientist II position requires the ability to write protocols, complete studies, and write reports for medium complexity processes. The application of risk assessment methodology is required for this position in order to support a fast-paced Change Control system while maintaining all IVD Compliance Requirements, where applicable. The Scientist II may sit on Core Teams or assist the Tech Ops Core Team member in which they will develop processes and transfer knowledge to the Manufacturing teams. In addition, the Scientist II will investigate, strive to root cause, and propose solutions for manufacturing challenges of moderate complexity. This position is constantly cross functional in nature and requires independent thought and schedule adherence, under moderate levels of guidance from the Technical Operations team.

EDUCATION:

• Bachelor’s degree in Biology, Chemistry, or other similar Life Science field.

KNOWLEDGE, SKILLS AND ABILITY:

• Able to work independently, with mentorship from Technical Operations team.
• Good analytical skills, with an ability to use scientific knowledge and statistical methods.
• Excellent verbal and written communication skills
• Ability to learn new products and technology at a moderate speed.
• Strong laboratory skills and knowledge of safety precautions
• Strong project management and organizational skills.
• Possess a continuous process improvement mentality with the ability to optimally lead and handle change.
• Proficient in use of Microsoft Office Suite.
• Exhibits a high level of quality (right the first time), integrity (do what you say you are going to do), and cross functional behaviour (always stay above the line). Embody the Thermo Fisher 4-I Values at all times.

EXPERIENCE:

• 3-5 years relevant experience in medical device or pharmaceutical area.
• Previous experience of working with ELISA kits
• Familiarity working within a QMS system and ISO regulations.
  At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.
  Apply today! http://jobs.thermofisher.com
  Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status

• Coordinate and perform validation projects and protocols in support of process validation of moderate complexity.
• Write protocols and reports.
• Perform and lead Risk Assessment exercises in support of validation activities, and perform periodic reviews as needed.
• Coordinate activities in support of assigned projects working closely with Quality Systems and Subject Matter Authorities.
• Train and provide support to Operations to ensure protocols are implemented as intended.
• Maintain knowledge and comprehensive understanding of relevant Medical Device regulations and current interpretations affecting product and process validation.
• Act as a resource to other departments for product and process knowledge.
• Performs root cause analysis and suggest workarounds and/or solutions for recurring issues of moderate complexity.
• Adopts PPI as a culture and as way of life and works with Operations & Quality to drive efficiency and implement future state processes.
• Participant in our PPI Lean Enterprise initiatives driving improvements through customer delivery & improved quality, as well as cost reduction/avoidance to drive growth and improve profitability.
• Performs other duties as assigned.