Study Director - Chemistry

Overview

At TÜV SÜD we are passionate about technology. Innovations impact our daily lives in countless ways, and we are dedicated to being a part of that progress. We test, we audit, we inspect, we advise. We never stop challenging ourselves for the safety of society and its people. We breathe technology, we strive for professional excellence, and we leave a mark.

We take the future into our hands. We are TÜV SÜD.

• Lead GLP-compliant chemistry studies for medical device testing, ensuring scientific integrity and regulatory compliance.
• Serve as the single point of control for study design, execution, and reporting in line with FDA GLP (21 CFR Part 58), ISO 17025, and ISO 10993 standards.
• Collaborate with clients and internal teams to align timelines, deliverables, and expectations.
• Provide technical guidance on method selection, troubleshooting, and interpretation of results.
• Prepare and approve study reports to ensure accuracy and timely delivery.
• Support audits and inspections related to study conduct and data integrity.

• Bachelor’s degree in Chemistry or related field.
• Minimum 2 years of experience in a regulated laboratory environment.
• Proven experience as Study Director under GLP or similar role in ISO 17025 environment.
• Strong knowledge of FDA GLP regulations and analytical chemistry techniques.
• Preferred:
• Experience with extractables and leachables testing.
• Familiarity with ISO 10993 series.
• Excellent technical writing and project management skills.

• A collaborative and inclusive work environment.
• Opportunities for professional development and growth.
• Competitive compensation and benefits package.
• Global exposure through cross-functional projects.

• The anticipated annual base pay range for this full-time position is $70,000 – $90,000. Actual base pay will be determined based on various factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include an annual bonus target, subject to eligibility and other requirements. Additionally, we offer a comprehensive benefits package to employees, including a 401(k) plan with employer match, up to 12 weeks of paid parental leave for birthing parents and 2 weeks for other parents, health plans (medical, dental, and vision), life insurance and disability, and generous paid time off.
• Workplace model:
  On-site
• Travel:
  Up to 10% domestic travel; occasional international travel with advance notice.
• We welcome applications from people of all backgrounds, experiences, and perspectives.

Equal Opportunity Employer - Disability and Veteran

TÜV SÜD America, Inc. is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, creed, religion, ancestry, marital status, genetics, national origin, sex, sexual orientation, gender identity and expression, age, physical or mental disability, veteran status and those laws, directives, and regulations of Federal, State, and Local governing bodies or agencies. We participate in the E-Verify Employment Verification Program.

Work Area:
Medical Devices & Healthcare

Country/Region:
United States

Job Location:

New Brighton

Working Model:
Onsite

Employment Type:

Full time / regular

Company: TÜV SÜD America Inc.

Org Unit Code: BRL-LSUP

Requisition