Supervisor, QC Bioassay

Job Description

Job Description:

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 Analytical team for our Biologics Division in St. Louis, MO.

How will you make an impact?

The QC Analytical supervisor’s primary responsibility is to supervise and develop the staff to perform routine activities in accordance with cGMP regulations and ThermFisher standards to meet departmental and organizational goals. This position entails managing employees to support qualification assays, to perform transfer and validation assays, batch release, process and facility support testing to meet customer needs. The supervisor is also expected to represent the department in regulatory agency, internal and partner audits. The individual will also provide technical expertise to resolve routine to complex QC issues pertaining to ELISA and cell-based bioassays, provide assay execution support, and conduct training for QC analytical personnel. Additional responsibilities include supporting the department to establish robust work processes and assess for continuous improvement opportunities.

The QC Analytical Supervisor will report directly to the QC Analytical Manager, and will manage the activities of 5-10 members of ELISA and Cell-based bioassay team. 

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.
• Overall creation and coordination of work schedules for team.
• Provide technical and compliance guidance on Test Methods, qualification, validation and transfer protocols and reports. Revise/review specifications, SOPs, and other documents regarding QC-Analytical testing and assay execution.
• Train new hires on department processes, procedures and tools.
• Interact with auditors/clients during visits and tours.
• Oversee daily activity for the group to ensure appropriate quality and volumetric output and maintenance of schedules.
• Perform in-lab assay execution support for validation, qualification studies or routine testing, when needed
• Set objectives and tasks for staff and regularly review staff progress in meeting objectives
• Review and approval of documentation generated by the group.
• Lead investigations in the case of deviations, and assists in the resolution of Out of Specification (OOS), complaints, discrepancies and CAPA (corrective actions preventive actions)
• Establish work plan and staffing for each phase of project, and arrange for assignment of project personnel
• Notify Senior Management of potential quality or regulatory issues that may impact product quality or regulatory compliance
• Effectively communicate with peers, manufacturing, AD and QC staff, to resolve technical issues and direct activities.
• Provide support to site Safety initiatives.
• Review FTE assessments to determine time frame, limitations, procedures for accomplishing project, staffing requirements, and allotment of available resources to various phases of project.
• Perform any other tasks as requested by Senior Management to support Quality oversight activities

How will you get here?

Education

• Bachelor’s Degree in a Biological Science related field

Experience

• 5+ years of related experience in the biopharmaceutical or pharmaceutical industry.
• 2+ years of supervisory/team lead experience within the pharmaceutical industry, preferably in ELISA or cell-based bioassay field.
• Extensive knowledge of GMP regulations in a cGMP manufacturing environment. 
• Working Knowledge of scientific principles for wide range of analytical techniques strongly preferred. ELISA and cell-based assay experience with large molecules is strongly recommended.
• 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.
• 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)
• Knowledge of Qualification and Validation requirements for analytical methods
• Ability to interpret and relate Quality Standards for implementation and review
• Ability to make sound decisions about scheduling, allocation of resources, and managing priorities
• Ability to communicate clearly and professionally in writing and verbally
• Flexibility in problem solving, providing direction and work hours to meet business objectives
• Working knowledge in 5S, SAP, Nextdocs and Trackwise preferred
• 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 70,000 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

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

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. 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.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.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.