Manufacturing Validation Specialist bei Bamfhealth

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 BAMF Health Radiopharmacy Mission is to "Enable Precision Medicine through Radiopharmaceuticals". The Manufacturing Validation Specialist is a cornerstone of this mission, leading the chemistry and manufacturing aspects of technology transfer, PET radiopharmaceutical production, and new site launches. This role pioneers the production of novel radiopharmaceuticals, supports drug manufacturing operations during critical production phases, and drives BAMF’s national expansion by ensuring seamless site scalability. By authoring manufacturing documents, executing validation runs, and collaborating with cross-functional teams, this role ensures compliance with regulatory standards and internal quality requirements, directly enabling new drug availability and operational growth.

Duties and Responsibilities, including but not limited to:

• Develop critical protocols to enable technology transfer and qualification of cutting-edge radiopharmaceuticals, ensuring flawless execution of new drug launches

• Pioneer PET production runs to validate manufacturing processes and perfect radiopharmaceutical output, bringing life-saving drugs to patients

• Lead equipment qualification, system validation, and cleaning verification in collaboration with validation teams to uphold BAMF’s world-class standards

• Resolve challenges by leading investigations and documenting deviations during technology transfers, keeping projects on track and compliant

• Empower BAMF’s radiopharmacy team by training colleagues on innovative PET manufacturing techniques and providing hands-on production support post-transfer

• Master the operation of advanced production equipment (e.g., cyclotrons, chemistry modules) – leverage the knowledge gained through tech transfer to facilitate operations throughout the BAMF radiopharmacy network as a technical subject matter expert ​

• Collaborate with cross-functional teams and external partners to drive development, validation, and method transfers for radiopharmaceutical manufacturing and quality control

• Support PET production, performing complex compounding and manufacturing processes, ensuring drug production continuity

• Perform aseptic testing and manipulations, including sterility testing, pyrogen testing, final product enclosure assembly, and final product manipulations; adhering to BAMF’s rigorous standard operating procedures

• Launch world-class production facilities to scale BAMF’s Radiopharmacy network, ensuring operational readiness and GMP compliance for new site activation

• Safeguard BAMF’s mission by delivering documentation that upholds the highest standards of GMP manufacturing and BAMF’s Quality Management System

Basic Qualifications:

• Bachelor’s degree or equivalent in applied science or related field required

• 2 years of experience with pharmaceutical manufacturing working in a GMP environment required

• Familiarity with CDMO and CMO work required

• Foundational expertise in the setup, operation, and maintenance of production equipment (e.g., cyclotrons, chemistry modules) and method transfers for radiopharmaceutical manufacturing required

Preferred Qualifications:

• Master’s degree in applied science or related field preferred

• Background in product research and development preferred

• Demonstrated experience in the operation, use, and maintenance of pharmaceutical production equipment and cleanroom facilities. Experience in the manufacturing of radiopharmaceutical products preferred

• Experience in the manufacturing of radiopharmaceutical products, particularly PET radiopharmaceuticals, preferred

• Experience supporting new site launches in a pharmaceutical or radiopharmacy setting preferred

Schedule/Compensation Details:

• Employment Status: Full time (1.0 FTE)

• Weekly Scheduled Hours: 40

• Hours of Work: 8-hour shift, start time between 6:00 PM and 8:00 PM.

• Days worked: Monday to Friday

At BAMF Health, our top priority is patient care. To ensure we are able to drive a Bold Advance Medical Future, we offer a well-rounded benefit package to care for our team members and their families. Highlights include:

• 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

Disclaimer

BAMF Health provides equal opportunities to all employees for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

BAMF Health will reasonably accommodate qualified individuals with a disability so that they can perform the essential functions of a job unless doing so causes a direct threat to these individuals or others in the workplace and the threat cannot be eliminated by reasonable accommodation or if the accommodation creates an undue hardship to BAMF Health.

BAMF Health is an Equal Opportunity Employer and will not accept or tolerate discrimination or harassment against any applicant, employee, intern, or volunteer based upon the following characteristics: race, color, religion, creed, national origin, ancestry, sex, age, qualified mental or physical disability or handicap, sexual orientation, gender identity/expression, transgender status, genetic information, pregnancy or pregnancy-related status, marital status, veteran status, military service, any application for any military service, or any other category or class protected by applicable federal, state, or local laws.