Head Of Product Development and Manufacturing

Reporting to the Director, Nuclear Manufacturing, the Manager, Product Development, is responsible for leading a team of Product Development scientists performing technology transfer activities for clinical phase and commercial radiopharmaceuticals under contract with innovator partners. The Product Development team, as part of the larger Technical Operations team, is tasked with the development and technology transfer of sponsor radiopharmaceutical products into and among our network of qualified manufacturing facilities. As a member of the local management team, the individual will be responsible for the coordination and deployment of appropriate resources supporting the adaptation, setup, transfer, and maintenance of sponsor drug products with strict adherence to cGMP, GDP, environmental health and safety and related guidelines, and internal policies and procedures. Specific duties will at a minimum comprise technical evaluation of new sponsor products, process and analytical equipment selection, maintaining governance documentation, as well as occasional process qualification and method validation activities typical for a cGMP pharmaceutical manufacturing operation, including the preparation of chemicals and components, the operation of production and laboratory equipment, and the performance of GMP procedures. The ideal candidate will have experience with regulatory guidelines (USP/EP/ISO/ICH/CFR), troubleshooting and maintaining process and/or analytical instrumentation typical of a radiopharmaceutical environment, and strong communication and leadership skills, as well as a proven track record of leading laboratory investigations and improvements.

Planning and evaluating the transfer of manufacturing and testing procedures established by internal product development teams and external product sponsors for our network of cGMP manufacturing facilities.
Administrate, track and report (execute where necessary) on the manufacturing and testing activities required for process qualification and method validation according to study protocols and standard operating procedures. Collaborate and support execution of equipment qualification, computer system validation, and cleaning verification protocols developed in partnership with validations personnel.
Lead and/or support 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 transfers.
Enable a culture of free communication on all issues related to safety, quality, and compliance to leadership.

With responsibility for the technical transfer of new sponsor products, and maintenance and technical support of existing sponsor products, the Manager of Product Development must provide insight and recommendations to set the operational strategy for long-term and sustainable growth.
Ensure a high degree of compliance with relevant cGMP and regulatory requirements across all managed technology transfer, manufacturing, and testing activities.
Partner with business development during the evaluation of new CDMO opportunities for local pre-commercial manufacturing and testing facilities.
Support the development of and provide functional leadership for technology transfer programs in related facilities.
Develop, monitor, and report performance indicators to highlight progress, risks, and mitigation strategies for relevant technology transfer projects.
Provide technical support as a legacy owner of sponsor products manufactured at relevant facilities.

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. A background in product research and development preferred.
Demonstrated experience in the operation, use, and maintenance of pharmaceutical production and analytical equipment. Direct experience in the manufacture and testing 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. 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.
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 and testing schedules among qualified facilities.
Prior experience leading technology transfer, and/or manufacturing and testing operations within a biotechnology, pharmaceutical, or radiopharmaceutical company across all phases of product development.
Experience working with contract manufacturing as well as working with collaboration partners.

Deep technical and scientific competencies across multiple modalities.
Demonstrated ability to analyze and extrapolate data, and hypothesize, plan and implement scientific strategies.

Personal Characteristics
An individual of unquestioned personal integrity who will be viewed as trustworthy both within the company, as well as with external relations.
A mission-driven individual with high energy and high levels of perseverance.

Bonus eligible: Medical, dental and vision coverage

• Health savings account (HSA)
• Flexible spending accounts (FSAs)
• Short- and long-term disability coverage
• Application window anticipated to close: if interested in opportunity, please submit application as soon as possible.

Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate’s geographical location, relevant education, experience and skills and an evaluation of internal pay equity.
Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.
Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.