Executive Director of Manufacturing
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 PositionDicerna Pharmaceuticals, Inc.
is seeking a highly experienced and dynamic professional to direct manufacturing, and corresponding CMC regulatory activities.
The Executive Director of Manufacturing Operations is accountable for clinical and commercial 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.
RelationshipsThis role will report to the SVP of Technical Operations.
This role will work cross-functionally with all departments.
Position will have direct reports.
Essential FunctionsProvide leadership, vision, and management to the Manufacturing functionLead all aspects of drug product manufacturing operations at CMO s to manufacture commercial and clinical parenteral medicines according to approved protocols, regulations, and schedulesGuide and oversee validation activities involving DP Manufacturing equipment and processes.
Partner with Chemical development to implement new production processes.
Processes may include but not limited to formulation, filling, lyophilizationManage key manufacturing metrics / goals, support critical program milestones, and drive continuous improvement initiatives that are essential to meeting patient and business needsCollaborate with Human Resources and other functions to develop a multi-year staffing and recruiting plan for manufacturingRapidly and accurately communicate issues to Senior Leadership.
Resolve manufacturing and facility issues to mitigate any supply disruptions to our patientsWork effectively across all departments, such as Quality Assurance, Facilities, Engineering, Program Management, Regulatory, Quality Control, IT, and Supply ChainWrite, review, and/or approve Standard Operating Procedures, specifications, regulatory filing, or other controlled documents as neededOversee and approve schedules, production plans, and material requirementsEnsure the effective use of material, equipment and personnel in producing quality productsPrepare and administer expense and capital budgets for the function.
Recommend capital expenditures and aids in the realization of capital projectsPhysical Requirements0-10% overnight travel required.
Development Of PeopleSupervisory, 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.
QualificationsMS/PhD in Biochemistry/Microbiology/Chemistry/Engineering or related discipline and 15
years in a cGMP setting preferredIn-depth experience in pharmaceutical operations associated with aseptic processingExperience working to standards required for regulatory compliance of Aseptic Processing facilitiesUnderstanding of engineering and process knowledge associated with various sterilization technologies, GMP utilities and associated pharmaceutical processesExperience with the drug product formulation processUnderstanding of equipment, instrumentation, and materials of construction to design, specify, procure, start-up, fully commission and troubleshoot equipment and systemsAbility to perform risk assessmentsExperience in problem solving and continuous improvement techniquesExcellent verbal and written communication skillsAbility to work effectively directing a manufacturing team and CMOsStrong planning & organizational skills (and an ability to work to targets, deadlines, and prioritize)In compliance with Colorado s Equal Pay for Equal Work Act, see compensation and benefits below:
The base compensation range for this position is $200,000 to $270,000.
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.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
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 PositionDicerna Pharmaceuticals, Inc.
is seeking a highly experienced and dynamic professional to direct manufacturing, and corresponding CMC regulatory activities.
The Executive Director of Manufacturing Operations is accountable for clinical and commercial 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.
RelationshipsThis role will report to the SVP of Technical Operations.
This role will work cross-functionally with all departments.
Position will have direct reports.
Essential FunctionsProvide leadership, vision, and management to the Manufacturing functionLead all aspects of drug product manufacturing operations at CMO s to manufacture commercial and clinical parenteral medicines according to approved protocols, regulations, and schedulesGuide and oversee validation activities involving DP Manufacturing equipment and processes.
Partner with Chemical development to implement new production processes.
Processes may include but not limited to formulation, filling, lyophilizationManage key manufacturing metrics / goals, support critical program milestones, and drive continuous improvement initiatives that are essential to meeting patient and business needsCollaborate with Human Resources and other functions to develop a multi-year staffing and recruiting plan for manufacturingRapidly and accurately communicate issues to Senior Leadership.
Resolve manufacturing and facility issues to mitigate any supply disruptions to our patientsWork effectively across all departments, such as Quality Assurance, Facilities, Engineering, Program Management, Regulatory, Quality Control, IT, and Supply ChainWrite, review, and/or approve Standard Operating Procedures, specifications, regulatory filing, or other controlled documents as neededOversee and approve schedules, production plans, and material requirementsEnsure the effective use of material, equipment and personnel in producing quality productsPrepare and administer expense and capital budgets for the function.
Recommend capital expenditures and aids in the realization of capital projectsPhysical Requirements0-10% overnight travel required.
Development Of PeopleSupervisory, 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.
QualificationsMS/PhD in Biochemistry/Microbiology/Chemistry/Engineering or related discipline and 15
years in a cGMP setting preferredIn-depth experience in pharmaceutical operations associated with aseptic processingExperience working to standards required for regulatory compliance of Aseptic Processing facilitiesUnderstanding of engineering and process knowledge associated with various sterilization technologies, GMP utilities and associated pharmaceutical processesExperience with the drug product formulation processUnderstanding of equipment, instrumentation, and materials of construction to design, specify, procure, start-up, fully commission and troubleshoot equipment and systemsAbility to perform risk assessmentsExperience in problem solving and continuous improvement techniquesExcellent verbal and written communication skillsAbility to work effectively directing a manufacturing team and CMOsStrong planning & organizational skills (and an ability to work to targets, deadlines, and prioritize)In compliance with Colorado s Equal Pay for Equal Work Act, see compensation and benefits below:
The base compensation range for this position is $200,000 to $270,000.
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.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
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