CCIT Technical Lead — Lab Strategy & Compliance

Ddltesting; Eden Prairie (MN); On-site; USD 120,000 - 140,000; Full time

Benefits offered by this job

Medical Insurance

Vision Insurance

Health Savings Account (HSA)

Flexible Spending Account (FSA)

Basic Life and AD&D / Voluntary Life

Short-Term Disability

Long-Term Disability

Pet Insurance

401(k) Retirement Plan

Paid Holidays

PTO

Job summary

DDL, Inc. is seeking a CCI Technology Lead in Eden Prairie, MN. This full-time role leads CCIT laboratory operations, oversees method development and validation, and ensures compliance with USP <1207>, cGMP, and ISO 17025. The position includes directing staff, audits, and collaboration with clients.

Salary ranges from $120,000 to $140,000 annually with bonus eligibility up to 10%. Occasional travel up to 20% may be required. Strong technical writing and leadership are essential.

Qualifications

• Bachelor’s or Master’s degree in Engineering, Chemistry, Materials Science, or related field.
• 7+ years of experience in pharmaceutical, medical device, or regulated laboratory environment.
• Direct experience with CCIT methods and USP <1207> required.
• Experience in CDMO or contract testing laboratory environment required.
• Knowledge and understanding of CCIT instrumentation operation and test execution.
• Demonstrated leadership experience managing technical teams.
• ISO 17025 laboratory experience and familiarity with cGMP

Responsibilities

• Establish, lead, and manage CCIT laboratory operations in a regulated environment.
• Serve as technical SME for USP <1207> and related regulatory requirements.
• Oversee method development, validation, and routine testing activities.
• Lead audits for FDA and client inspections and support CAPA programs.
• Review protocols, reports, deviations, and validation summaries.
• Drive continuous improvement of quality, efficiency, and lab performance.
• Collaborate with Business Development on proposals and scope.
• Train, mentor, and develop technical staff.

Skills

CCIT methods

Leadership

Regulatory compliance

Laboratory operations

Technical writing

Client facing

Education

Bachelor's or Master's in Engineering, Chemistry, Materials Science

Tools

Microsoft Office

LIMS

QMS System

Job description

DDL, Inc. is seeking a CCI Technology Lead in Eden Prairie, MN. This full-time role leads CCIT laboratory operations, oversees method development and validation, and ensures compliance with USP <1207>, cGMP, and ISO 17025. The position includes directing staff, audits, and collaboration with clients.

Salary ranges from $120,000 to $140,000 annually with bonus eligibility up to 10%. Occasional travel up to 20% may be required. Strong technical writing and leadership are essential.