Scientist II (QC Project Lead)
Company: Thermo Fisher Scientific
Location: Saint Louis
Posted on: November 23, 2021
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
InformationThis 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,
- 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
- 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
- Trains junior level staff in analytical method transfer.
- Other job duties as assignedHow will you get
here?EducationBachelor'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
- Extensive knowledge of GMP regulations in cGMP manufacturing
- 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 BiologicsKnowledge,
- 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
- 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
essentialAt 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.
Keywords: Thermo Fisher Scientific, St. Louis , Scientist II (QC Project Lead), Other , Saint Louis, Missouri
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