Manager - Drug Product Manufacturing & Development

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Job description

About the Department

The Boulder Site is home to the specialized technical operations/CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the hub for all manufacturing-related activities for GalXC and GalXC-Plus investigational therapeutics developed from Novo Nordisk's acquisition of Dicerna Pharmaceuticals, Inc. in December 2021. With a new laboratory completed in 2021 to support analytical and process development, 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. Ranked the No. 1 Place to Live for the second consecutive year by U.S. News & World Report, Boulder is experiencing a renaissance in biotech investment and is one of the world's leading centers for oligonucleotide innovation and manufacturing. Together, we are driving change. Are you ready to make a difference?

The Position

Novo Nordisk GNAT division is seeking a highly experienced and dynamic professional to manage parenteral drug product manufacturing, and corresponding CMC regulatory activities. The Manager of Drug Product Manufacturing is accountable for clinical phase 1 and 2 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.

Relationships

This position reports to the Executive Director, Manufacturing.

Essential Functions

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, 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 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

Physical Requirements

Approximately 0 - 10% overnight travel. Physical Requirements: 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

BS/MS in Biochemistry/ Chemistry/Engineering or related discipline and 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 (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

"The base compensation range for this position is $120 K to $150 K. 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 10/28/2024. The Company may however extend this time-period, in which case the posting will remain available on our career's website at .

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

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing.

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-. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

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