Scientist II (QC Project Lead)

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Job description

Job Title Scientist II (QC Project Lead)

Requisition ID:

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.

Location/Division Specific Information

This position supports the QC Analytical team for our Biologics Division in St. Louis, MO.

How will you make an impact?

The Scientist II (QC Project Lead) will be responsible for the performance of project management for the Client Facing- Quality Control in support of Commercial and Clinical Biopharmaceutical Manufacturing. The individual will be responsible for following Current Good Manufacturing Practices (cGMP) and carrying out a variety of functions related to Quality Control methods, scheduling, deviations and CAPAs. Functions may include, but are not limited to: Managing QC needs for clients, developing timelines and schedules for QC needs for complex projects, communication with both internal and client facing stakeholders, and preparation and revision of documents per ICH guidelines for Biopharmaceutical Drug Substance (such as product specifications, BOT, validation protocols and reports).

What will you do?

• Work directly with client site Program Manager to direct assess and direct work related to the Quality Control team.
• Liaise between internal and client teams to drive QC projects and process solutions.
• Prepare and present weekly project updates to client management via project meetings.
• Manage client needs related to QC scheduling and visits in support of site departments (Program Management, Operations, QA)
• Interface directly with program management for scheduling and forecasting of QC specific scheduling and workflow
• Monitor AFS qualification and QC validation, transfer and release activities in progress
• Coordinate and communicate with Program Managers for project related needs and issue
• Authors analytical method validation and transfer documents, Specification Documents, BOT, Certificate of Testing, SOP, and all other documents necessary for the job.
• Opens and manages change controls
• Carries out duties in compliance with all local, state and federal regulations and guidelines including FDA, EPA, and OSHA.
• Complies with all company and site policies and procedures. Reports any non-conformances. Initiates and/or leads resolution efforts and laboratory investigations.
• Recognize and solve potential problems and evaluate project/program effectiveness from a QC standpoint
• Interacts with auditors and clients during visits and tours
• Trains junior level staff in analytical method transfer.
• Other job duties as assigned

How will you get here?

Education

Bachelor's Degree in a Biological Science related field required and 5+ years related experience in biopharmaceutical or pharmaceutical industry.

Experience

• At least two years of project lead experience within the pharmaceutical industry.
• Extensive knowledge of GMP regulations in cGMP manufacturing environment.
• Working Knowledge of scientific principles for wide range of analytical techniques strongly preferred. HPLC and ELISA experience with large molecules is preferred.
• Advanced knowledge of FDA guidance for industry for Analytical Procedures and Methods Validation for Drugs and Biologics

Knowledge, Skills, Abilities

• Ability to understand customer requirements related to Quality control, including processes and equipment.
• Outstanding technical writing skills.
• Strong interpersonal skills including actively listening, conflict resolution and the ability to effectively influence diverse stakeholders for positive outcome.
• Ability to build strong relationships with client while instilling trust and confidence
• Highly organized with attention to detail
• Familiar with standard project management concepts, tools and responsibilities (objectives, scope, deliverables)

• Ability to manage multiple client, and their needs related to QC activities, scheduling and visits in support of site departments (Program Management, Operations, QA)
• Strong organizational skills in monitoring QC qualification, validation and release activities in progress
• Excellent communication skills - Coordinate and communicate with Program Managers for project related needs and issues
• Working knowledge of cGMPs and Quality Control regulatory requirements
• Experience with authoring documents for qualification/validation of QC assays.
• Performs analytical and technical troubleshooting
• Routine use of MS Excel, MS PowerPoint, and MS Word is essential

At Thermo Fisher Scientific, each one of our 65,000 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!

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.