Associate Director - Drug Product Manufacturing & Development

Associate Director - Drug Product Manufacturing & Development

Facility : Manufacturing

Location : Boulder, CO, US

About the Department

Our Research & Development organization brings together the best minds in life science innovation. The teams located in facilities in Lexington, Watertown, Cambridge and Seattle reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future, creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple modalities and therapeutic areas. We recognize that improving human health starts here and that patients rely on us. Our R&D hub merges biotech speed and agility with large pharmaceutical company quality, resources, and stability, uniting the best of both worlds to develop new medicines for patients.

The Position

The Associate Director of Drug Product Manufacturing is accountable for all clinical drug product manufacturing including process characterization activities to support commercialization for nucleic acid programs and will have thorough knowledge of cGMP's for aseptic pharmaceutical products. Frequent cross functional interaction with multiple departments will be required while supporting multiple projects. The position will manage CMO's to ensure the continuous supply of product and apply risk mitigation strategies, as well as perform formulation studies in a laboratory setting as needed. This position will lead a team of Drug Product Managers and manage their own projects.

Relationships

This position reports to the Executive Director, Manufacturing.

Essential Functions

• 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
• Rapidly and accurately communicate issues to Senior Leadership. Resolve manufacturing and facility issues to mitigate any supply disruptions to our patients
• Work effectively across all departments, such as Quality Assurance / Control, Chemical Development, Program Management, Regulatory, Analytical Development, Materials Management, and Clinical Supply
• 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
• Manage DP team resource loading and personnel development
• Ensure the effective use of material, equipment, and personnel in producing quality products
• Optimize and investigate formulation, sterilization, and filling processes and parameters through experiments in a laboratory setting

Physical Requirements

Approximately 15 20% overnight travel. Ability to lift 0 10lbs.

Development of People

Supervisory. Ensure that reporting personnel have individual development plans (IDP), with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process. Ensure that the IDP forms include completed learning and aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility. Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way.

Qualifications