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Thermo Fisher Scientific Specialist III, Manufacturing Compliance in Cambridge, Massachusetts

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.

At Viral Vector Services (VVS) a division of Thermo Fisher Scientific we deliver, from process development through commercial supply, we offer the expertise and resources necessary to help clients deliver innovative gene therapies. Placed in the forefront of our leading and cutting edge Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases.

How will you make an impact?

The Manufacturing Compliance Specialist III reports into the Viral Vector Services group at Thermo Fisher Scientific and is based in the Cambridge, MA office. The Specialist III in this role will be part of a cohesive team responsible for Deviations, CAPAs, and Change Controls for all phases of manufacturing. The Specialist III uses expert knowledge of cGMP regulations and project management to ensure manufacturing readiness. The incumbent will also support equipment, documentation, investigations and improvement initiatives within the manufacturing operations. Works independently with minimal supervision and direction. Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion.

What will you do?

  • Support manufacturing at tech transfer with change controls if needed

  • Support manufacturing corrective and preventative actions

  • Support manufacturing internal and external observations

  • Lead manufacturing investigations if needed

  • Support daily huddle meetings if needed

  • Practices and promotes safe work habits and adheres to safety procedures and guidelines

  • Utilizes manufacturing process knowledge and investigational skills to identify and resolve manufacturing issues and drive continuous improvement in process operations

  • Maintain and Improve Systems:

  • Performs training with staff for Deviations, Change Controls, and CAPAs as needed

  • Supports cross-functional continuous improvement teams, with Engineering, Validation, Quality Assurance, Quality Control, Facilities, and Manufacturing Science and Technology

  • Supports cross-functional company goals for Site Metrics

  • Builds cross-functional relationships and enhances relationships with team members

  • Works cooperatively with others to meet group and organizational goals

  • Participates in initiatives to support, innovation and continuous improvement activities and improved compliance with quality procedures, policies and regulations.

  • Participate in client and planning meetings as requested

How will you get here?

  • Bachelors Degree preferred

  • Minimum of 3 - 5 years experience in pharmaceuticals manufacturing and/or quality

  • Demonstrated ability to motivate exempt and non-exempt employees and demonstrated management skills, (i.e., business knowledge, leadership, communication, ability to analyze technical issues, conflict resolution). Thorough knowledge of cGMPs

  • Strong interpersonal and communications skills; written and oral

Knowledge, Skills, Abilities

  • Ability to function in a fast paced, dynamic environment with multiple priorities simultaneously

  • Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community

  • Ability to make decisions and work with minimal to moderate supervision

  • Able to provide effective written or verbal communication to peers, senior associates, and area management within their operational groups

  • Strong planning, organization and multitasking skills

  • Solid understanding of root cause analysis tools

  • Strong Leadership skills

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.