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 Information

This position supports the QC Stability team for our Biologics Division in St. Louis, MO.

How will you make an impact?

The Scientist I, QC Stability will be assigned a variety of activities required to support the site’s stability programs. This individual will report directly to the Supervisor, QC Stability. This position will spend a majority of their time focused on cGMP activities that support the complete lifecycle of sample management during a stability study which include, but not limited to: stability sets, pulls, aliquoting, shipments, disposal, and supporting LIMS and/or paper GMP documentation at each of those steps per site SOPs. In addition, this individual will be assigned 1-3 clients and directly interface with their clients as needed.

This role will routinely interface cross-functionally with several departments internally. He/she will also be the customer facing representative for their client’s stability programs: attending regular project meetings for updates, work with customers to develop, design, and implement stability programs in alignment with company and ICH guidelines. He/she will also be responsible for ownership over client stability documentation and oversight on the testing status/results for their projects.

What will you do?

• Complete assigned stability tasks in a timely manner and in alignment with department SOPs and stability protocols.
• Handle stability samples in the QC laboratory: setting stability studies, pulling stability samples, performing aliquoting in an aseptic environment, moving stability material for scheduled PMs, disposal/shipment of stability samples.
• Responsible for maintaining master schedule, or equivalent system, of assigned client stability programs.
• Responsible for management of assigned client stability programs and ensures tasks assigned to them are on schedule.
• Coordinate the stability testing schedule and maintaining relationships with testing laboratories and sample management group to ensure timely completion and reporting of results for a stability time point.
• Author and/or revise internal procedures, stability protocols, interim and final stability reports as assigned.
• Manage and monitor stability inventory, milestones and detailed timelines for stability studies. Plan, direct, coordinate, and lead activities of assigned client stability program to ensure that goals and objectives are accomplished within the prescribed time frame.
• Use LIMS system to generate testing samples, document stability sample movements and activities, and monitor testing statuses.
• Complete GMP documentation in a manner consistent with company’s GDP and Data Integrity policies.
• Attend assigned client meetings and on-site visits as needed.
• Serve as client stability lead for up to 3 programs; interfacing directly with client counterparts to gather information, discuss on-going stability programs, troubleshoot and resolve stability related issues, etc.
• Participate in the continuous process improvements related to the stability program.
• Participate in site Safety initiatives.
• Other job duties as assigned.

How will you get here?

• Bachelor’s Degree in a Biological Science or related field and 1-3 years related experience in biopharmaceutical or pharmaceutical industry.

• At least have one-year experience within the pharmaceutical industry, preferably in a stability/sample management or laboratory-based role.

• Knowledge of GMP regulations in cGMP manufacturing environment.
• At least one-year experience with GDP documentation in a cGMP laboratory.
• Awareness of scientific principles and/or willingness to learn a wide range of techniques strongly preferred.
• Intermediate/Advanced skills with Microsoft Office Applications: Word, Excel, PowerPoint, Teams, OneNote, and Project.
• Experience with laboratory and quality systems is preferred: EDMS, QMS, LMS, LIMS, and stability specific laboratory systems.
• Experience in a customer facing role is a plus, but not required.

Knowledge, Skills, Abilities

• Ability to understand customer requirements related to Quality control, including processes and equipment.
• Moderate 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.
• Desire to increase understanding of ICH guidelines, regulations, and industry best practices pertaining to stability.
• Highly organized with attention to detail.
• Awareness of standard project management concepts, tools and responsibilities (objectives, scope, deliverables).

• Willingness to improve in quality and operational excellence.