The Manager, Commercial Manufacturing will play a critical role within the Technical Operations organization to provide technical and operational support for the commercial manufacture of both drug substances and drug products at both internal and contract manufacturing facilities used by Cardinal Health Nuclear and Precision Health Solutions (NPHS). The individual will collaborate with colleagues in Operations, Strategic Sourcing, Quality Assurance, and Regulatory Affairs to ensure the manufacture and timely release of material produced and analyzed at our partner manufacturing and testing facilities, as well as provide routine technical support to our internal operations network. The incumbent will be expected to develop methods and evaluation criteria to plan, monitor, and document all manufacturing, testing and packaging activities across our network of commercial partners in order to manage the overall efficiency of our suppliers and identify potential quality, technical, business, or safety-related risks in our supply chain.
- Form strategic partnerships with both internal and external technical and operational colleagues to understand scientific, quality, regulatory, and business needs of the NPHS product portfolio
- Provide technical and functional subject matter expertise to ensure a robust product supply across the NPHS external manufacturing network
- Collaborate with Strategic Sourcing, Quality Assurance, and Regulatory Affairs for the scheduling, manufacturing, and reporting of all external production and testing activities
- Establish key performance indicators in alignment with business and operational goals; maintain and report applicable vendor and product metrics
- Identify technical gaps in the manufacture and testing of NPHS products; develop appropriate mitigation plans where necessary, and escalate accordingly
- Provide impact assessment and technical support to Operations, Quality Assurance, and Regulatory Affairs related to manufacturing component, material, and/or process changes
- Deliver general technical advice on process deviations and investigations; support hypothesis testing and data collection to facilitate the timely closure of non-conformance events
- Participate in routine operations meetings and ensure that validated manufacturing processes and test methods remain within a state of control
Experience, Knowledge, and Skills Required:
- Bachelor’s/Master’s degree in Chemistry or Engineering with 5 – 7 years of progressively responsible experience in the pharmaceutical or biotechnology industry in a cGMP manufacturing environment.
- Working understanding of FDA and ICH requirements as they relate to the manufacture, testing, and lifecycle management of pharmaceutical products
- Demonstrated analytical and problem solving skills coupled with strong technical writing and verbal communication skills; must possess the ability to clearly convey technical information and concepts/principles to a diverse audience
- Excellent interpersonal, influencing, and leadership skills, with the ability to develop effective working relationships among internal/external partners and teams
Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.