Manager - Drug Product Manufacturing & Development

Novo Nordisk - Boulder, CO

Full-time - Manager

Boulder, CO

Merchant Wholesalers, Nondurable Goods

About the position

The Manager of Drug Product Manufacturing at Novo Nordisk is responsible for overseeing parenteral drug product manufacturing and related CMC regulatory activities. This role requires extensive knowledge of cGMP for aseptic pharmaceutical products and involves collaboration with various departments to ensure the continuous supply of products while managing multiple projects. The position also includes performing formulation studies and implementing new production processes at contract manufacturing organizations (CMOs).

Responsibilities

• Manage all aspects of drug product manufacturing operations at CMOs to manufacture clinical parenteral medicines according to approved protocols, regulations, and timelines
• Partner with Chemical development to implement new production processes at CMOs, including formulation, sterilization, filling, and lyophilization
• Manage key manufacturing metrics/goals, support critical program milestones, and drive continuous improvement initiatives
• Rapidly and accurately communicate issues to Senior Leadership and resolve manufacturing and facility issues
• Work effectively across all departments such as Quality Assurance/Control, Chemical Development, Program Management, Regulatory, Quality Control, Supply Chain, and Clinical
• Write, review, and/or approve Standard Operating Procedures, specifications, regulatory filings, Master/Executed Batch Records, or other controlled documents
• Manage timelines, production plans, and material requirements
• Ensure effective use of material, equipment, and personnel in producing quality products
• Optimize and investigate formulation, sterilization, and filling processes through laboratory experiments

Requirements

• BS/MS in Biochemistry/Chemistry/Engineering or related discipline
• 5+ years in a cGMP setting
• In-depth experience in pharmaceutical operations associated with aseptic processing
• Experience working to standards required for regulatory compliance of Aseptic Processing facilities
• Understanding of engineering and process knowledge associated with various sterilization technologies, GMP utilities, and associated pharmaceutical processes
• Experience with the drug product formulation process and optimization
• Understanding of equipment, instrumentation, and materials of construction to design, specify, procure, start-up, fully commission and troubleshoot equipment and systems
• Ability to perform risk assessments
• Experience in problem solving and continuous improvement techniques
• Excellent verbal and written communication skills
• Ability to work effectively managing CMOs
• Strong planning & organizational skills
• Proficient in MS Word, Excel, MS Project & PowerPoint
• Understanding of national and international regulatory requirements as it relates to Aseptic Manufacturing
• Proficient in generating and executing protocols and reports

Benefits

• Medical, dental and vision coverage
• Life insurance
• Disability insurance
• 401(k) savings plan
• Flexible spending accounts
• Employee assistance program
• Tuition reimbursement program
• Voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance
• Sick time policy
• Flexible vacation policy
• Parental leave policy