QC Supervisor

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Job description

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

At Viral Vector Services (VVS) a division of Thermo Fisher Scientific we deliver, from process development through commercial supply, we offer the expertise and resources necessary 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.

How will you make an impact?

This position will work in the GMP compliant QC Laboratories to develop, qualify or validate, and conduct cell-based, nucleic acid-based, protein-based, and chemistry-based assays that support quality control of biopharmaceutical products being developed and manufactured. Analytical assays performed would support GMP manufacturing activities and release testing.

The incumbent will be expected to drive the Cell Based Assay Qualification/Validation work for all QC timelines and ensuring adherence to timelines to support client milestones. The incumbent will work with Internal and External stakeholders to oversee the projects. Additionally, the incumbent will be expected to technically interpret, write controlled documents and reports, and review data produced by self and participate in laboratory investigations. Will interact with other departments to ensure that sample flow, supply chain, and equipment disposition are correctly maintained. Mentor technicians/ scientists to conduct/Troubleshoot/develop these assays; write/ review cGMP reports/ documents and test records.

What will you do?

* Coordinate all Cell Based Assay Qualification/Validation/Bridging work.
* Provide support for all Analytical Assay Qualification/Validation/Bridging work.
* Prepares/reviews/approves sampling plans, protocols, reports, data tables, test methods and writes SOPs. Writes URS for equipment commissioning
* Function as a subject matter expert for Cell Based Assays.
* Attend internal and client facing meetings to provide technical feedback and support planning activities.
* Responsible for writing and reviewing investigations - invalids, minor and major events lab events and deviations, involved in investigations and troubleshooting
* Review data generated by reports and solve issues
* Will mentor Scientists and Lab Associates
* Collaborates with PM and technical leads from other cross functional areas to ensure clear expectations and successful deliverable
* Conducts resource modeling for team's projects, forecasting and resource and equipment allocation
* Acts as a functional group technical lead on multiple programs, with responsibility for running those programs within own functional group
* Regularly performs 1:1's with direct reports, coaching, mentoring and developing. Periodic 1:1's with indirect reports. Trains and mentors senior level scientists and supervisors.
* Coordinate tech transfer of methods and review all associated documents, including Tech Transfer protocols, SOPS, TRS, AQ/Val reports and protocols
* Drive functional, technical and operational excellence
* Responsible for continually improving the department via operational excellence initiatives, advances in technology, changes to regulatory landscape or other organizational changes

How will you get here?

Education:

* Master's degree preferred/ Bachelor's degree in Life Sciences, Chemistry, Chemical/Biological Engineering or related field required.

Experience:

* BS Degree in related field, 4+ years of experience or superior demonstration of skill sets or background.
* MS Degree in related field, 2+ Years of experience or superior demonstration of skill set or background
* Hands-on experience in cell culture and cell-based assays.
* Additional experience in PCR based assays is preferred.
* Experience in method development, Qualification and validation activities. Well versed in cGMP/ICH/FDA/EU regulations and guidelines preferred
* Experience in a QC GMP Laboratory, including GMP documentation and review, Author Protocols and reports, and exceptions preferred
* Advanced skills in Electronic Sample management and quality systems (e.g.: Trackwise). Experience in handling deviations and OOS preferred

Knowledge, Skills, Abilities:

* Electronic organizational skills using Microsoft Excel or other planning tools
* Ability to communicate/work in a high pressure/high paced environment
* Ability to multi-task and function effectively as a member of a team
* Advanced knowledge on analytical, biochemical or cell-based methods in Quality Control
* Excellent Leadership skills and people management experience.
* Ability to read, analyze, and interpret technical procedures, or governmental regulations
* Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
* Ability to speak effectively before groups of customers or employees

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 global team of 90,000 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!

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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