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 QC Stability supervisor will be responsible for improvement, development, implementation and maintenance of the stability programs and internal procedures and processes. He/She will ensure that the stability programs are in compliance with regulatory requirement for clinical and commercial products.

The QC Stability Supervisor will consult with Patheon Core Teams, will report directly to the QC Senior Manager, and will manage the activities of all members of QC stability team. He/She will work closely within the QC organization and external laboratories to ensure testing completion and will review and trend the stability results. He/She will also be responsible for attending new client meetings for their stability program as well as working with Program Managers to determine Timelines and Budgets for FTE Resources.

What will you do?

• Provide leadership to assigned staff by performing the following: leading organizational change; developing and empowering staff; cultivating relationships; putting staff in a position to succeed, meeting their personal career goals while also achieving organizational goals; building effective teams that apply their diverse skills and perspectives to achieve common goals; driving engagement and creating a climate where staff are motivated to do their best.

• Maintain stability programs in compliance with regulatory requirements and commitments for clinical and commercial products.
• Author and/or revise internal procedures, stability protocols, interim and final stability reports. May author or supervise QC stability team members in writing of stability-related records and investigations.
• Develop and implement processes as part of continuous process improvements related to the stability program.
• Perform periodic review and analysis of stability results
• Ensure stability chambers have been appropriately validated, calibrated and maintained.
• Manage and monitor stability inventory, milestones and detailed timelines for stability studies. Plan, direct, coordinate, and lead activities of each client stability program to ensure that goals and objectives are accomplished within the prescribed time frame.
• Review FTE assessments to determine time frame, limitations, procedures for accomplishing project, staffing requirements, and allotment of available resources to various phases of project.
• Responsible for supervision of all QC stability personnel assigned to each client stability program 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.
• Oversee inspections and inventory of stability samples annually for each study.
• Outline work plan to assign duties, responsibilities, and scope of authority.
• Maintain master schedule of all client stability programs.
• Responsible for overall quality and management of all the stability programs.
• Attend new client meetings and on-site visits.
• High involvement with client audits, internal site audits and regulatory audits.
• Performance management for staff.
• Provide support to site Safety initiatives.
• Other job 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.

• At least three years supervisory/ team lead experience within the pharmaceutical industry, preferably in a QC senior stability or analytical laboratory role.
• Extensive knowledge of GMP regulations in cGMP manufacturing environment.
• Working Knowledge of scientific principles for wide range of techniques strongly preferred. Knowledge of analytical, micro and protein methods with large molecules is preferred.
• Routine use of MS Excel, MS PowerPoint, and MS Word is essential

Knowledge, Skills, Abilities

• Ability to understand customer requirements related to Quality control, including processes and equipment.
• Outstanding technical writing skills.
• Solid 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 for biologics drug substance in a commercial 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.
• Ability to inspire and foster innovation, collaboration, transparency and team effectiveness.

At 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! http://jobs.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.