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 Information
 
This position supports the Quality Control, Analytical team for our Biologics Division in St. Louis, MO.
 
 
How will you make an impact?
 
The Scientist II (QC Analytical 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. You 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, 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 QC qualification, validation and release activities in progress
• Coordinate and communicate with Program Managers for project related needs and issue
• Author, review qualification, validation, method transfer documents.
• Carry out duties in compliance with all local, state and federal regulations and guidelines including FDA, EPA, and OSHA.
• Comply with all company and site policies and procedures. Report any non-conformances. Initiate and/or lead resolution efforts and laboratory investigations.

• Strong customer facing experience
• Knowledge of GMP regulations in cGMP manufacturing environment.
• Working knowledge of scientific principles for wide range of analytical techniques strongly preferred.
• Five years related experience in Biopharma or pharma area.
• At least two years of project lead experience within the pharmaceutical industry
• Ability to understand customer requirements related to Quality control, including processes and equipment.
• Highly organized with attention to detail.
• Excellent communication skills.
• Solid experience with MS Excel, MS PowerPoint, and MS Word is essential
• Experience with authoring documents for qualification/validation of QC assays.
• HPLC and ELISA experience with large molecules is preferred.

• Ability to build strong relationships with client while instilling trust and confidence
• Familiar with standard project management concepts, tools and responsibilities (objectives, scope, deliverables)
• Ability to manage client needs related to QC scheduling and visits in support of site departments (Program Management, Operations, QA)

 
 
This position has not been approved to provide relocation assistance
 
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.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.