Job Title Scientist II, Quality Control Stability

Requisition ID: 115531BR

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 II, QC Stability will be responsible managing assigned client stability programs and working in a QC environment, and will ensure that the stability programs are in compliance with regulatory requirement for clinical and commercial products.

The Scientist II, QC Stability will report directly to the Supervisor, QC Stability. This is a client facing position, this role will interface directly with assigned clients.

He/She will be assigned multiple client projects and serve as the stability lead for those assignments. As stability lead, he/she will be responsible for interfacing 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. He/She will spend a portion of their time in a QC laboratory handling stability samples and performing tasks in support of the QC Stability department’s requirements.

What will you do?

• Maintain stability programs in compliance with regulatory requirements and commitments for clinical and commercial products.
• Responsible for overall quality and management of assigned client stability programs.
• Maintain master schedule, or equivalent system, of assigned client stability programs.
• Responsible for management of assigned client stability programs and ensures tasks 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.
• 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.
• Perform periodic review and analysis of stability results.
• 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.
• 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.
• Attend assigned client meetings and on-site visits.
• Serve as client stability lead; 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.
• Minor involvement with client audits, internal site audits and regulatory audits.
• Participate in site Safety initiatives.
• Other job duties as assigned.

How will you get here?

Education

• Bachelor’s Degree in a Biological Science related field and 3-5 years related experience in biopharmaceutical or pharmaceutical industry.

Experience

• At least three years’ experience within the pharmaceutical industry, preferably in a stability or analytical laboratory role.

• Extensive knowledge of GMP regulations in cGMP manufacturing environment.
• OTJ application of the ICH guidelines and scientific principles applying to stability regulations.
• Working Knowledge of scientific principles for wide range of techniques strongly preferred. Knowledge of analytical, micro and protein methods with large molecules is 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 position is a plus, but not required.

Knowledge, Skills, Abilities

• Ability to understand customer requirements related to Quality control, including processes and equipment.
• Outstanding technical writing skills.
• Moderate knowledge and understanding of US and international (e.g. EU, ICH, GXP) regulations and guidance applicable to stability of biological products
• Experience with developing and implementation of QC stability programs in a pharma/biopharma GMP environment.
• 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 drive functional, technical and operational excellence.

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.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.