Novo Nordisk is looking to solve the business problem of ensuring the continuous supply of clinical drug product for nucleic acid programs by managing CMOs, applying risk mitigation strategies, and performing formulation studies. The company also aims to support commercialization through process characterization and drive continuous improvement initiatives to meet patient and business needs.
Requirements
- In-depth experience in pharmaceutical operations associated with aseptic processing required
- Proven leadership of technical teams required
- Experience working to standards required for regulatory compliance of Aseptic Processing facilities required
- Understanding of engineering and process knowledge associated with various sterilization technologies, GMP utilities, and associated pharmaceutical processes required
- Experience with the drug product formulation development process and optimization preferred
- Understanding of equipment, instrumentation, and materials of construction to design, specify, procure, start-up, fully commission and troubleshoot equipment and systems required
- Ability to perform risk assessments required
Responsibilities
- Lead, manage, and advise all aspects of drug product manufacturing operations at CMOs to manufacture clinical parenteral medicines according to approved protocols, master batch records, regulations, and timelines
- Lead and be an example for a drug product team that is responsible for ensuring clinical supply using aseptic manufacturing
- Identify and work with formulation development CROs to implement new production processes at CMOs and NDA-enabling work. Processes may include but are not limited to formulation, sterilization, filling, and lyophilization
- Responsible for key manufacturing metrics / goals, support critical program milestones, and drive continuous improvement initiatives that are essential to meeting patient and business needs
- Write, review, and/or approve Standard Operating Procedures, specifications, regulatory filings, Master/Executed Batch Records, or other controlled documents as needed
- Responsible for managing timelines, production plans, and material requirements
- Optimize and investigate formulation, sterilization, and filling processes and parameters through experiments in a laboratory setting
Other
- Approximately 15 – 20% overnight travel.
- Ability to lift 0 – 10lbs.
- Supervisory.
- Excellent verbal and written communication skills required
- Ability to work effectively managing CMOs required
