Qc Scientist Ii

Job Description
As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner, and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Location/Division Specific Information
This position will be site based in Lexington, MA and will support our Viral Vector Services (VVS Lexington) business unit of Thermo Fisher Scientific. At VVS Lexington, we deliver process development through commercial supply and offer the expertise and resources vital to help clients deliver innovative gene therapies. Placed in the forefront of our leading and cutting edge Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases.
Discover Impactful Work:
This position will work in the GMP QC Laboratories to qualify and conduct chemistry-based assays that support quality control of biopharmaceutical products being developed and manufactured. Supports analytical test method validation and transfer activities at and between external sites for PCR. Will perform routine assays and testing including but not limited to ddPCR, pH, appearance, osmolality, SDS page, and ELISAs. Responsible for coordinating or chipping in to sophisticated projects of moderate scope within QC and cross-functionally. Independently runs analytical reference standard programs for commercial drug substances and drug products including qualification /requalification, inventory, supply / shipping.
A Day in the Life:

• Independently apply scientific judgment and contribute to landmarks related to specific projects.
• Represent QC business processes and needs within the department and at cross functional forums.
• Apply proficiency in analytical techniques within and outside of your specific group.
• Resolve technical and tactical operations problems, communicate to collaborators in a timely manner.
• Ensure sample testing achievements are met and supervise due dates through completion to meet or exceed metrics.
• Ensure method performance and sample data trending is kept up to date.
• Maintain cGMP and GDP compliance within their laboratories.
• Generate, revise, and/or approve SOP or test methods.
• Review and ensure training requirements are completed and maintained for analysts and self.
• Maintain a safe working environment in the laboratory and participate in safety and compliance inspections.
• Support regulatory inspections and audits.

Keys to Success:
Education

• Bachelor's degree in science; preferably Microbiology or Biology, or related field preferred.
• High school diploma or equivalent required.

Experience

• 2-4 years' experience with relevant laboratory experience in a regulated manufacturing or QC laboratory environment; 3-7 years preferred.
• Experience with electronic systems such as LIMS and Trackwise is an advantage.

Knowledge, Skills, Abilities

• Applied knowledge and in-depth understanding of GMP Quality Control systems.
• The candidate must have analytical experience with molecular techniques compendial methods.
• Shown problem solving ability, interpersonal, oral and written communication skills.
• Ability to prioritize objectives from multiple projects and scheduled timelines while maintaining flexibility and attention to detail.
• Understanding of applicable regulatory requirements.
• Must be proactive, committed and have the ability to adapt to a change.
• Significant laboratory documentation review and revision experience.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
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.
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