QC Analytical Development Leader – GMP & Strategy

Regulatory Jobs; Greenville (NC); On-site; USD 140,000 - 200,000; Full time

Job summary

Thermo Fisher Scientific Inc. is seeking a Sr. Manager, QC Analytical Development to lead the Analytical Development Laboratory unit.

You will set quality policies for materials, products and the production environment, and participate as a key member of the site Management Team. The role provides technical and operational leadership for lab operations and support to manufacturing facilities. The candidate will bring extensive cGMP pharmaceutical experience, leadership in analytics, and strong

Qualifications

• BS/BA in Chemistry or related field required.
• 10+ years of cGMP experience in the pharmaceutical industry; Steriles manufacturing experience required.
• 7+ years in a leadership role; committed to employee engagement and development.
• Outstanding attention to detail and organizational skills.
• Excellent written and verbal communication; ability to write quality reports and present.
• Proficiency in Microsoft Suite (Word, Excel, PowerPoint).
• Knowledge of microbial test methods including endotoxin and sterility testing; particulate matter testing a plus.

Responsibilities

• Lead analytical development and method transfer activities for New Business Development projects.
• Advise on regulatory submissions and support product revisions/new introductions.
• Develop and monitor budgets for the Lab Services Department and plan long-term goals.
• Maintain safe, injury-free workspace in line with safety and training requirements.
• Drive organizational change, empower staff, build effective teams and foster engagement.

Skills

Leadership

cGMP experience

Regulatory knowledge

Analytical chemistry

Data integrity

Budget planning

Communication skills

Microsoft Office

Team building

Project management

Education

BS/BA in Chemistry or related field

Job description

Thermo Fisher Scientific Inc. is seeking a Sr. Manager, QC Analytical Development to lead the Analytical Development Laboratory unit.

You will set quality policies for materials, products and the production environment, and participate as a key member of the site Management Team. The role provides technical and operational leadership for lab operations and support to manufacturing facilities. The candidate will bring extensive cGMP pharmaceutical experience, leadership in analytics, and strong