Analytical Validation Specialist

BAMF Health • Grand Rapids, MI

1d • Onsite

About The Position

Join BAMF Health, where you're not just part of a team; you're at the forefront of a revolution in Theranostics, changing lives for the better. As a member of our global team, you'll contribute to pioneering technology and deliver top-tier patient care. Located in the heart of downtown Grand Rapids, our cutting-edge global headquarters resides within the state-of-the-art Doug Meijer Medical Innovation Building. Step into our modern and spacious facilities, where innovation thrives and collaboration knows no bounds. Join us in our mission to make Theranostics accessible and affordable for all, and be part of something truly remarkable at BAMF Health. The Analytical Validation Specialist is responsible for the planning, execution, documentation, and lifecycle management of analytical method validations in compliance with cGMP regulations and applicable regulatory guidelines (e.g., ICH Q2/Q14, USP, FDA). This role supports analytical method development, validation, transfer, and verification activities for drug products. The specialist authors and reviews validation protocols, reports, and supporting documentation, ensures data integrity, investigates deviations and out of specification results, and collaborates cross functionally with QC, QA, Manufacturing, and external partners. The position requires strong technical expertise in analytical techniques, a high level of attention to detail, and the ability to ensure methods are scientifically sound, reliable, and suitable for their intended use throughout the product lifecycle.

Requirements

• Bachelor's Degree in Applied Science or equivalent required
• 3 years hands-on experience with analytical equipment working in a GMP environment in the pharmaceutical or biotechnology industry required
• Foundational expertise in the setup, operation, and maintenance of conventional analytical instrumentation (HPLC/GC/TLC/etc.) and modern chromatography data systems required
• Experience in method transfer of HPLC, TLC, or GC QC methods required
• Proven ability to author and review validation protocols, reports, SOPs, and technical documentation.
• Experience investigating deviations, OOS/OOT results, and supporting regulatory inspections required.

Nice To Haves

• Master's Degree in Applied Science preferred
• Demonstrated experience in the operation, use, and maintenance of pharmaceutical production equipment and cleanroom facilities.
• Experience in development and manufacture of radiopharmaceutical products preferred
• Familiarity with CDMO and CMO work preferred

Responsibilities

• Develop and validate GMP-compliant analytical methods for a variety of radiopharmaceutical drug products using HPLC, TLC, GC, endotoxins, etc.
• Generate all study protocols and controlled documentation necessary to enable the technology transfer and qualification of contracted products maintaining consistency with BAMF QMS and general principles of GMP manufacturing.
• Lead the technical execution of analytical development activities at our Grand Rapids Facility
• Work collaboratively with the BAMF Radiopharmacy team and external partners on development, validation, verification, and method transfers for the manufacture and QC of radiopharmaceuticals
• Work closely with scientific staff to evaluate technical feasibility of new products
• Assist the development team in building project plans, timelines, and reports for the client
• Support internal tech transfers and train BAMF Radiopharmacy personnel on new testing procedures and provide routine production support following completion of technology transfer
• Identify and remove barriers that could impact program objectives, priorities, timelines, and quality. Communicate risks and mitigations to leadership.
• Help build technical expertise to meet future radiopharmaceutical drug product needs
• Perform other duties as assigned

Benefits

• Employer paid High Deductible Health Plan with employer HSA contribution
• Flexible Vacation Time
• 401(k) Retirement Plan with generous employer match
• Several benefit options including, but not limited to; dental, vision, disability, life, supplemental coverages, legal and identity protection
• Free Grand Rapids downtown parking

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 11-50 employees