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.
The BioProduction Division is one of the fastest growing businesses in the company, supporting developers and manufacturers of biological-based therapeutics and vaccines. With our portfolio of best-in-class products that span the bioprocessing workflow from discovery through large-scale commercial production, our business is driving performance in bioprocessing through collaboration with our customers.
How will you make an impact?
Within the growing Quality organization of the Bedford, MA facility, we are seeking a career-conscious HPLC Leader will be motivated by this exciting opportunity for an experienced Quality Professional to lead and grow a POROS workstream team to meet the needs of multiple businesses including one that is fast-growing.
You'll be a proven team leader with experience in building high-performance teams, bringing a strong operational understanding and technical expertise to enhance our Quality Team.
What will you do?
Supporting the Quality Organization, the HPLC Leader will:
- HPLC leadership role and testing expertise to HPLC group in the Quality Control department.
- Individual will provide directives for HPLC day-to-day testing, schedule work to support production needs and any other testing required for stability and project work etc.
- This position to take initiatives and work closely with production, analytical development and other departments.
- As a part of continuous improvement, this position will review and revise HPLC methods and implement best lab practices.
- Adhere to in-house processes and procedures maintaining compliance to ISO 13485 standards.
- Provide guidance and expertise to HPLC operations personnel and foster a culture of learning.
- Oversee Out Of Specification (OOS) investigations and general troubleshooting with an effort towards timely resolutions.
- Take initiatives to improve lab efficiency and expedite overall POROS HPLC operations.
- Partner with cross functional team members to drive and execute critical quality, cross-functional and cross-site initiatives.
- Develop and execute to a resource plan for POROS HPLC to support business sustainability, risk mitigation and growth.
- Maintain and support a safety and quality culture.
How will you get here?
Education and Experience
- Bachelor's or equivalent degree from accredited college/university in relevant scientific discipline and have a strong leadership and technical background. Preferred advanced degree i.e., Masters or Doctorate
- Minimum 5 years of relevant Quality Control Lab experience
- Experience training to Quality Control and other staff
- Experience with internal and customer audits
Knowledge, Skills, Abilities
- Knowledge of Quality standard (e.g., ISO 13485), FDA, ICH (International Council for Harmonization) Quality guidelines
- Working knowledge of HPLCs and other analytical equipment.
- Good understanding of ISO 13485 OR ISO 9001 requirements including CAPA, Risk Assessments, Deviation investigation and Change Control process
- Document review experience such as, but not limited to, in-process, final batch release and stability data
- Understanding of how to set up and maintain product stability programs and sample/raw material retain programs
- Familiarity with SAP, Trackwise, Agile, E1, LIMS systems
- Ability to work independently or as part of a team
- Flexibility to adapt to a dynamic environment and manage activities to meet the needs of the business while maintaining a focus on quality
- Versed in continual process improvement practices such as Kaizens, Gemba, 3P, 5S, Standard Work and others
- Excellent inter-personal, communication and organizational skills with good attention to detail
- Ability to produce and present original quality communication materials for internal and external audiences
At Thermo Fisher Scientific, each one of our 75,000 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.
To Apply, please click the following link: https://thermofisher.contacthr.com/75752615
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