Senior Chemist, Nuclear Manufacturing

Anticipated pay range: $66,500 - $95,000

Bonus eligible: No

Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.

• Medical, dental and vision coverage
• Paid time off plan
• Health savings account (HSA)
• 401k savings plan
• Access to wages before pay day with myFlexPay
• Flexible spending accounts (FSAs)
• Short- and long-term disability coverage
• Work-Life resources
• Paid parental leave
• Healthy lifestyle programs

Application window anticipated to close: 08/29/2024 *if interested in opportunity, please submit application as soon as possible.

About the Job

The Sr. Chemist, Nuclear Manufacturing position is part of a growing Technical Operations team within Cardinal Health’s Nuclear and Precision Health Solutions organization tasked with the development and enabling technology transfer of sponsor radiopharmaceutical products into and among our network of qualified manufacturing facilities. This position will be responsible for the adaptation, setup, transfer, and maintenance of sponsor drug products with strict adherence to cGMP, GDP, environmental health and safety and related guidelines, as well as internal policies and procedures. Specific duties will minimally comprise technical evaluation, material selection, process and analytical equipment configuration, document creation, method validation, and process qualification, as well as occasional production and/or testing activities typical for a cGMP pharmaceutical manufacturing operation including the preparation of chemicals and components, the operation of production and laboratory equipment, and the execution of standard operating procedures for routine manufacture and testing of radiopharmaceutical products. Technical Operations personnel are expected to work directly with Operations personnel to ensure incoming processes, procedures, and methods align with existing infrastructure. The preferred individual will also possess sufficient technical, functional, and administrative competence to work largely independently, in a team environment, to meet project timelines.

Responsibilities

• Evaluate, create, adapt, and transfer manufacturing and testing procedures established by internal product development teams and external product sponsors, in collaboration with internal operations teams, for our network of cGMP manufacturing facilities.
• Generate all study protocols and controlled documentation necessary to enable the technology transfer and qualification of contracted products.
• Execute manufacturing and testing activities required for process qualification and method validation according to study protocols and standard operating procedures. Generate study reports where required.
• Lead investigations and document deviations and exceptions occurring during technology transfer.
• Train facility personnel on new manufacturing and testing procedures and provide routine production and/or testing support to operations during technology transfer across the network.
• Facilitate day-to-day operation and maintenance of relevant production equipment and testing instrumentation. Clean and maintain all relevant production, testing, and related laboratory equipment.
• Communicate all issues related to safety, quality, and compliance to leadership.

Qualifications

• Bachelor’s degree in engineering or a physical science with at least five years of experience working in a GMP environment in the pharmaceutical or biotechnology industry preferred.
• A 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 manufacture of radiopharmaceutical products preferred.
• Foundational expertise in the setup, operation, and maintenance of conventional analytical instrumentation (HPLC/GC/TLC/etc.) and modern chromatography data systems.
• Ability to work in a controlled environment requiring special attention to environmental, health, and safety regulations.
• 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 manufacturing and testing processes, and facility and systems infrastructure, to streamline operational efficiency across a broad range of products.
• Flexibility to travel and work periodic off-shift hours to accommodate routine production schedules among qualified fa