Manager - Drug Product Manufacturing

About the Department

Dicerna, a Novo Nordisk company, is focused on driving innovation in RNAi (ribonucleic acid interference) to selectively target and silence genes that cause or contribute to disease. Our proprietary GalXC™ and GalXC-Plus™ RNAi technologies have the potential to address conditions that are difficult or impossible to treat with other modalities. Established as a Transformational Research Unit (TRU) following Novo Nordisk’s acquisition of Dicerna Pharmaceuticals, Inc. in December 2021, the Dicerna TRU is a unique new organization within Novo Nordisk that brings together the best of both worlds – the agility, collaborative pioneering spirit and calculated risk-taking profile of a biotech along with the scale, resources and capabilities of a global leader in drug development. With approximately 200 researchers, scientists, drug developers and operational staff, we are a team of inventive and entrepreneurial thinkers pushing the boundaries of science to create and drive new RNAi-based therapies for both rare and more prevalent diseases from the bench to the clinic. Together, we are driving change. Are you ready to make a difference?

The Position

Dicerna Pharmaceuticals, Inc. is seeking a highly experienced and dynamic professional to manage drug product manufacturing, and corresponding CMC regulatory activities. The Manager of Drug Product Manufacturing Operations 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.

Relationship

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 schedules
• Partner with Chemical development to implement new production processes at CMOs
• Processes may include but not limited to formulation, filling, 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, Chemical Development, Program Management, Regulatory, Quality Control, and Supply Chain
• Write, review, and/or approve Standard Operating Procedures, specifications, regulatory filing, or other controlled documents as needed
• Manage schedules, production plans, and material requirements
• Ensure the effective use of material, equipment and personnel in producing quality products
• Optimize and investigate formulation processes and parameters through experiments in a laboratory setting

Physical Requirements

Approximately 0 – 10% overnight travel. Ability to lift 0 – 10lbs.

Qualifications

• BS/MS in Biochemistry/Microbiology/Chemistry/Engineering or related discipline and 5+ years in a cGMP setting
• In-depth experience in pharmaceutical operations associated with aseptic processing required
• 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 required
• 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 $98,820 to $172,940. Base compensation is determined based on a number of factors.  In addition, this position is part of the Annual Performance Incentive Plan. The role may also be eligible for a long-term incentive bonus depending on level and 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 uncapped sick time policy, flex-able vacation policy, and parental leave policy.

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 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.