Thermo Fisher Scientific Scientist II (QC Analytical Project Lead) in Saint Louis, Missouri
When you join us at Thermo Fisher Scientific, you'll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 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.
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 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. He/She 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 issueOther job duties as assigned.
Authors, reviews qualification, validation, method transfer documents.
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.
Trains junior level staff in analytical method transfer.
How will you get here?
- Bachelor's Degree in a Biological Science related field is required.
5+ years related experience in biopharmaceutical or pharmaceutical industry.
At least two years of project lead experience within the pharmaceutical industry.
Experience with authoring documents for qualification/validation of QC assays.
HPLC and ELISA experience with large molecules is preferred.
Knowledge, Skills, Abilities
Extensive knowledge of GMP regulations in a cGMP manufacturing environment.
Working knowledge of scientific principles for a wide range of analytical techniques strongly preferred.
Routine use of MS Excel, MS PowerPoint, and MS Word is essential
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)
Knowledge of Qualification and Validation requirements for analytical methods
Ability to manage client needs related to QC 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
Ability to perform analytical and technical troubleshooting
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.
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.