Drug Product Manufacturing & Development Manager

About the Department

The Boulder Site is home to the specialized technical operations/CMC team for oligonucleotides and RNAi therapeutics. The CMC team works alongside Quality, Regulatory, Technical Operations and RNAi Early Development professionals at our Boulder, Colorado facility and works closely with our teams in Lexington, Massachusetts.  Together, we are driving change. Are you ready to make a difference.

The Position

Novo Nordisk in Boulder, Colorado, is seeking an experienced and dynamic professional to manage parenteral drug product manufacturing, and corresponding CMC regulatory activities. The Drug Product Manufacturing and Development Manager 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 Contract Manufacturing Organizations (CMO's) to support the continuous supply of product and apply risk mitigation strategies, as well as perform formulation studies in a laboratory setting as needed.

Relationships

This position reports to the Associate Director, Drug Product Manufacturing and Development. This position interacts with QA, QC, Internal Chemical/ Analytical Development, Program Management, CMC Regulatory, Manufacturing Operations, Contract Manufacturing Organizations, and Contract Research Organizations (CRO’s). This role is based in Boulder, CO.

Essential Functions

• Manage drug product manufacturing operations at CMOs to produce investigational parenteral medicines according to approved protocols, regulations, and timelines
• Support the technology transfer and scale up of internally & externally developed platform technologies to partner CMO’s or internal manufacturing
• Partner with Analytical/ Chemical development/ CROs to implement new production processes at CMOs. Processes may include but not limited to formulation, sterilization, and filling
• 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 Leadership. Resolve manufacturing and facility issues to mitigate any supply disruptions to our patients
• Work effectively across all departments, such as Quality Assurance/ Control, Analytical/ Chemical 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 according to project timelines
• 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 0 – 10% overnight travel. Ability to lift 0 – 10lbs.

Qualifications

• Bachelor's degree from an accredited university and 4+ years of experience required. Equivalent experience requirements for advanced degrees would be a Master's degree and 2+ years of experience, or a PhD and 0+ years of experience
• 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
• Experience manufacturing small scale lab batches for formulation development and process optimization
• Experience working with CMOs is preferred
• Strong planning & organizational skills (and an ability to work to targets, deadlines, and prioritize)
• Proficient in MS Word, Excel, Visio & PowerPoint
• Understanding of national and international regulatory requirements as it relates to Aseptic cGxP Manufacturing
• Proficient in generating and executing protocols and reports

The base compensation range for this position is $130,000 to $165,000. Base compensation is determined based on a number of factors. This position is also eligible for a 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. 

The job posting is anticipated to close on [insert 5 days from posting]. The Company may however extend this time-period, in which case the posting will remain available on our careers website at www.novonordisk-us/careers.com.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.