Sr. Chemist, Nuclear Manufacturing

Cardinal Health•Beltsville, MD

6d•Onsite

About The Position

Manufacturing is responsible for cost of production and maintenance activities including process improvement, supply chain management, quality assurance, employee safety and engagement, and environmental commitment. 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 engineering or a physical science with at least five years of experience working in a GMP environment in the pharmaceutical or biotechnology industry.
Demonstrated experience in the operation, use, and maintenance of pharmaceutical production equipment and cleanroom facilities.
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.
Position may require lifting or moving equipment weighing up to 40 lbs.
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 work periodic off-shift hours to accommodate routine production schedules among qualified facilities.

Nice To Haves

A background in product research and development preferred.
Experience in the manufacture of radiopharmaceutical products preferred.

Responsibilities

Evaluate, create, adapt, and transfer manufacturing and testing procedures established by internal product development teams and external product sponsors 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.
Complete equipment qualification, computer system validation, and cleaning verification protocols developed in partnership with validations personnel.
Lead investigations and document deviations and exceptions occurring during technology transfer.
Train facility personnel on new manufacturing and testing procedures and provide routine production support following completion of technology transfer.
Facilitate day-to-day operation and maintenance of production equipment and testing instrumentation.
Clean and maintain all production, testing, and related laboratory equipment during technology transfer.
Communicate all issues related to safety, quality, and compliance to leadership.