Scientist, Nuclear Manufacturing

Cardinal Health•Indianapolis, IN

1d•$92,000 - $118,170•Onsite

About The Position

Nuclear Manufacturing is responsible for the manufacturing of time sensitive radiopharmaceuticals in an integrity driven, highly regulated environment (i.e. FDA, NRC, DOT) to support patient treatment through disease diagnosis, staging, and monitoring.

Requirements

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.
Experience in working in a clean room environment, paying special attention to environmental, health, and safety regulation.
Experience in working directly on client projects and products, and providing guidance and support for implementation challenges.
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.
Desire to create, develop, and mature testing processes, and facility and systems infrastructure, to streamline operational efficiency across a broad range of products.
Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects
Works on complex projects of large scope
Develops technical solutions to a wide range of difficult problems
Solutions are innovative and consistent with organization objectives
Completes work; independently receives general guidance on new projects
Work reviewed for purpose of meeting objectives

Nice To Haves

4-8 years of experience, preferred
Bachelor's degree in related field, or equivalent work experience, preferred
A background in product research and development is preferred.
Position may require lifting or moving equipment weighing up to 75 lbs.
May act as a mentor to less experienced colleagues
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.