Radiopharmaceutical Process Scientist

cardinalhealth; Indianapolis (IN); On-site; USD 92,000 - 118,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

401k

Paid time off

HSA

Parental leave

Disability coverage

Job summary

Cardinal Health is seeking a qualified Manufacturing professional for its Nuclear Manufacturing division in Indianapolis. The role focuses on production of time-sensitive radiopharmaceuticals in a regulated GMP setting to support clinical and development projects.

The position requires 4–8 years of related experience and a life sciences or engineering background, with emphasis on clean room operations, documentation, and process improvement.

Qualifications

• Bachelor's degree in life sciences or engineering with at least four years of experience working in a GMP manufacturing environment in the pharmaceutical or biotechnology industry. A background in product research and development is preferred.
• 4-8 years of experience, preferred
• Commitment to maintain data integrity through strict adherence to standardized procedures and relevant compliance requirements, including the ability to clearly document all work activities in a timely manner.
• Motivation to work effectively and cooperatively with others, and to establish and maintain good working relationships.
• Flexibility to work periodic off-shift hours to accommodate routine production schedules among qualified facilities.
• Experience working with radioactive isotopes not required, but is preferred.

Responsibilities

• Perform and execute production for client drug products, including routine clinical trial manufacturing and developmental studies.
• Evaluate, create, adapt, and transfer testing procedures established by internal product development teams and external product sponsors for our Indianapolis theranostics cGMP radiopharmaceutical manufacturing facilities.
• Assist on creation of protocols and controlled documentation necessary to enable the technology transfer and qualification of contracted products. Generate study reports where required.
• Execute equipment qualifications developed in partnership with Validations personnel, as well as provide feedback and improvements to qualifications.
• Lead investigations and document deviations that occurred during technology transfer and routine production activities.
• Train facility personnel on new procedures and provide support to the facilities following completion of technology transfer.
• Facilitate day-to-day operation, maintenance and repair of manufacturing equipment. Clean and maintain all manufacturing equipment.
• Communicate all issues related to safety, quality, and compliance to leadership.
• Perform relevant documentation for maintenance activities, as well as modify and create SOPs.
• Provide input to the Product Development team regarding sponsor product manufacturing.

Job description

Cardinal Health is seeking a qualified Manufacturing professional for its Nuclear Manufacturing division in Indianapolis. The role focuses on production of time-sensitive radiopharmaceuticals in a regulated GMP setting to support clinical and development projects.

The position requires 4–8 years of related experience and a life sciences or engineering background, with emphasis on clean room operations, documentation, and process improvement.