Job DescriptionWhen 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 InformationThis position supports the QC Analytical team for our Biologics Division in St. Louis, MO.How will you make an impact?The job will be responsible for Quality Control Project Leads Department and will support of Commercial and Clinical Biopharmaceutical Manufacturing. They will be responsible for following Current Good Manufacturing Practices (cGMP). 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 customers, and managing change controls and revision of documents per ICH guidelines for Biopharmaceutical Drug Substance (such as product specifications, validation protocols and reports).What will you do?
Ensures the successful operations of the QC Leads team, providing support and setting team priorities
Establish meaningful goals and manage the performance of assigned personnel to those goals
Participates in troubleshooting, technical discussions, teleconferences, and client visits, as required
Proactively develops, manages, tracks and improves team’s performance. Set targets and monitors critical metrics for efficiency, compliance, and delivery.
Liaise between internal and client teams to drive QC projects and process solutions.
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
Facilitate and manage QC analytical meetings between client and designated internal SMEs to ensure completion of project prior to agreed timelines.
Monitor QC qualification, transfers, validation and release activities in progress. Provides risk mitigation strategies to ensure on time completion of activities.
Coordinate and communicate with Program Managers and clients for project related needs and issues.
Carries out duties in compliance with all local, state and federal regulations and guidelines including FDA, EPA, and OSHA.
Actively champions process improvement initiatives in the Project lead group, QC analytical group and inter-site collaboration (for co-validation, co-transfers etc)
Actively involved in scientific discussions with the Analytical Formulation Sciences team
Other duties as assigned
How will you get here?
Bachelor’s Degree in a Biological Science related field and 5+ years related experience in biopharmaceutical or pharmaceutical industry.
Experience
At least 2 years supervisory/ team 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 (HPLC, ELISA, Cell-Based Assay, Capillary Electrophoresis, etc.) strongly preferred.
Knowledge, Skills, Abilities
Ability to understand customer requirements related to Quality control, including processes and equipment.
Outstanding technical writing skills.
Strong social skills including actively listening, conflict resolution and the ability to effectively influence diverse customers for positive outcome.
Ability to build strong relationships with client while instilling trust and confidence
Highly organized with attention to detail, excellent interpersonal skills
Familiar with standard project management concepts, tools and responsibilities (objectives, scope, deliverables)
Advanced knowledge of FDA guidance for industry for Analytical Procedures and Methods Validation for Drugs and Biologics
Ability to drive functional, technical and operational excellence.
Ability to inspire and foster innovation, collaboration, transparency and team effectiveness.
Routine use of MS Excel, MS PowerPoint, and MS Word is crucial
Solid understanding of cGMPs and Quality Control regulatory requirements
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 (https://jobs.thermofisher.com/global/en/5-reasons-to-work-at-thermo-fisher-scientific) . 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.comThermo 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.We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.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.