Senior Manager, Drug Product Manufacturing & Development

Novo Nordisk • Boulder, CO

2d

About The Position

Novo Nordisk CMC Boulder division is seeking a highly experienced and dynamic professional to manage parenteral drug product manufacturing, and corresponding CMC regulatory activities. The Senior Manager, Drug Product Manufacturing and Development is accountable for clinical drug product manufacturing 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 work with 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.

Requirements

• Bachelor's degree and 8+ years of experience or Master's degree and 6+ years of experience or PhD and 3+ years of experience required
• 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 (and an ability to work to targets, deadlines, and prioritize)
• 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

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. Processes may include but not limited to formulation, sterilization, filling, and lyophilization
• Manage 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, Analytical Development, Program Management, Regulatory, Supply Chain, and Clinical
• Write, review, and/or approve Standard Operating Procedures, specifications, regulatory filings, Master/Executed Batch Records, or other controlled documents as needed
• Manage timelines, production plans, and material requirements
• 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

Benefits

• Company bonus based on individual and company performance
• Novo Nordisk offers long-term incentive compensation and or company vehicles depending on the position's level or other company factors
• Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance
• The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees