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Job DescriptionAs 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 InformationThis position supports the QC Analytical team for our Biologics Division in St. Louis, MO.How will you make an impact?The Scientist III (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: Leading QC needs for clients, developing timelines and schedules for QC needs for complex projects, communication with both internal and client facing collaborators, 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, Bill of Testing, Certificate of Testing, SOP, and all other documents as required.
Opens and manages change controls, CAPA's, or Deviations as required.
Carries out duties in compliance with all local, state and federal regulations and guidelines including FDA, EPA, and OSHA.
Aligns with all company and site policies and procedures.
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
Other job duties as assigned
How will you get here?Education
Required: Associates Degree with 7 or more years of relevant work experience or a Bachelor’s degree with 5 or more years of relevant work experience, STEM degree preferred - Biological Science related field highly desired
Relevant work experience includes working in biopharmaceutical or pharmaceutical industry
2+ years experience in a client facing and/or project lead experience role
Experience
Extensive knowledge of GMP and ICH 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 collaborators 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 interpersonal 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
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.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.
