Manager, Product Development

Cardinal Health•Indianapolis, IN

3d•$105,100 - $150,100•Onsite

About The Position

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. Accountabilities 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. Plan and deploy the necessary resources to generate all study protocols and controlled documentation necessary to enable the technology transfer and qualification of contracted products. 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. Generate study reports where required. 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. Responsibilities 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.

Requirements

Bachelor’s degree in engineering or a physical science
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 and analytical equipment.
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.
Ability to clearly document all work activities in a timely manner.
Excellent interpersonal skills, including the ability to influence others, resolve challenges diplomatically, and build strong working relationships across departments.
Exceptional oral and written communication skills for effective interaction with all levels of employees, senior leadership, and external partners.
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.
Exceptional interpersonal skills including the ability to influence behaviors and resolve challenges with poise, tact and diplomacy.
Demonstrated knowledge and understanding of relevant compliance principals and requirements as applied to diagnostic and therapeutic radiopharmaceutical products.
Demonstrated ability to analyze and extrapolate data, and hypothesize, plan and implement scientific strategies.
A proven ability to operate effectively in a rapidly changing environment where analytical skills and agility are equally as important.
A self-aware, self-motivated, self-confident individual who is comfortable operating with minimal direction and who thrives in a dynamic environment.
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.

Nice To Haves

A background in product research and development preferred.
Direct experience in the manufacture and testing of radiopharmaceutical products preferred.
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.

Responsibilities

Lead a team of Product Development scientists performing technology transfer activities for clinical phase and commercial radiopharmaceuticals.
Coordinate and deploy resources for adaptation, setup, transfer, and maintenance of sponsor drug products.
Perform technical evaluation of new sponsor products, process and analytical equipment selection, and maintain governance documentation.
Conduct process qualification and method validation activities.
Prepare chemicals and components, operate production and laboratory equipment, and perform GMP procedures.
Plan and evaluate the transfer of manufacturing and testing procedures.
Generate study protocols and controlled documentation for technology transfer and qualification.
Administer, track, and report on manufacturing and testing activities for process qualification and method validation.
Generate study reports.
Collaborate and support execution of equipment qualification, computer system validation, and cleaning verification protocols.
Lead and/or support investigations and document deviations and exceptions.
Train facility personnel on new manufacturing and testing procedures.
Provide routine production support.
Enable a culture of free communication on safety, quality, and compliance.
Provide insight and recommendations for operational strategy for long-term and sustainable growth.
Ensure high degree of compliance with relevant cGMP and regulatory requirements.
Partner with business development during evaluation of new CDMO opportunities.
Support development of and provide functional leadership for technology transfer programs.
Develop, monitor, and report performance indicators for technology transfer projects.
Provide technical support as a legacy owner of sponsor products.