Associate Director - Drug Product Manufacturing & Development
Novo Nordisk, Boulder, Colorado, United States, 80301
Associate Director - Drug Product Manufacturing & Development
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Associate Director - Drug Product Manufacturing & Development
role at
Novo Nordisk
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. 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 The Associate Director of Drug Product Manufacturing is accountable for all clinical drug product manufacturing including process characterization activities to support commercialization for nucleic acid programs 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 manage 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. This position will lead a team of Drug Product Managers and manage their own projects.
Relationships This position reports to the Executive Director, Manufacturing.
Essential Functions
Lead, manage, and advise all aspects of drug product manufacturing operations at CMOs to manufacture clinical parenteral medicines according to approved protocols, master batch records, regulations, and timelines
Lead and be an example for a drug product team that is responsible for ensuring clinical supply using aseptic manufacturing
Identify and work with formulation development CROs to implement new production processes at CMOs and NDA-enabling work. Processes may include but are not limited to formulation, sterilization, filling, and lyophilization
Responsible for 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, Analytical Development, Materials Management, and Clinical Supply
Write, review, and/or approve Standard Operating Procedures, specifications, regulatory filings, Master/Executed Batch Records, or other controlled documents as needed
Responsible for managing timelines, production plans, and material requirements
Manage DP team resource loading and personnel development
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 15 – 20% overnight travel. 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
Bachelor’s degree with 9+ years of experience, Master’s degree with 7+ years of experience, or PhD with 5+ years of experience in a cGMP setting required. Degree in Biochemistry/Chemistry/Engineering or related discipline required
In-depth experience in pharmaceutical operations associated with aseptic processing required
Proven leadership of technical teams required
Experience working to standards required for regulatory compliance of Aseptic Processing facilities required
Understanding of engineering and process knowledge associated with various sterilization technologies, GMP utilities, and associated pharmaceutical processes required
Experience with the drug product formulation development process and optimization preferred
Understanding of equipment, instrumentation, and materials of construction to design, specify, procure, start-up, fully commission and troubleshoot equipment and systems required
Ability to perform risk assessments required
Experience in problem solving and continuous improvement techniques required
Excellent verbal and written communication skills required
Ability to work effectively managing CMOs required
Strong planning & organizational skills (and an ability to work to targets, deadlines, and prioritize) required
Proficient in MS Word, Excel, MS Project & PowerPoint required
Understanding of national and international regulatory requirements as it relates to Aseptic Manufacturing required
Proficient in generating and executing protocols and reports required
Novo Nordisk is currently in the process of adjusting job titles globally. Please note that the job title listed in this advertisement may be subject to change. More detailed information will be provided during the recruitment process.
The base compensation range for this position is $148,290 to $259,510. 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.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
We’re not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long‑term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health.
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.
#J-18808-Ljbffr
Associate Director - Drug Product Manufacturing & Development
role at
Novo Nordisk
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. 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 The Associate Director of Drug Product Manufacturing is accountable for all clinical drug product manufacturing including process characterization activities to support commercialization for nucleic acid programs 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 manage 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. This position will lead a team of Drug Product Managers and manage their own projects.
Relationships This position reports to the Executive Director, Manufacturing.
Essential Functions
Lead, manage, and advise all aspects of drug product manufacturing operations at CMOs to manufacture clinical parenteral medicines according to approved protocols, master batch records, regulations, and timelines
Lead and be an example for a drug product team that is responsible for ensuring clinical supply using aseptic manufacturing
Identify and work with formulation development CROs to implement new production processes at CMOs and NDA-enabling work. Processes may include but are not limited to formulation, sterilization, filling, and lyophilization
Responsible for 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, Analytical Development, Materials Management, and Clinical Supply
Write, review, and/or approve Standard Operating Procedures, specifications, regulatory filings, Master/Executed Batch Records, or other controlled documents as needed
Responsible for managing timelines, production plans, and material requirements
Manage DP team resource loading and personnel development
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 15 – 20% overnight travel. 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
Bachelor’s degree with 9+ years of experience, Master’s degree with 7+ years of experience, or PhD with 5+ years of experience in a cGMP setting required. Degree in Biochemistry/Chemistry/Engineering or related discipline required
In-depth experience in pharmaceutical operations associated with aseptic processing required
Proven leadership of technical teams required
Experience working to standards required for regulatory compliance of Aseptic Processing facilities required
Understanding of engineering and process knowledge associated with various sterilization technologies, GMP utilities, and associated pharmaceutical processes required
Experience with the drug product formulation development process and optimization preferred
Understanding of equipment, instrumentation, and materials of construction to design, specify, procure, start-up, fully commission and troubleshoot equipment and systems required
Ability to perform risk assessments required
Experience in problem solving and continuous improvement techniques required
Excellent verbal and written communication skills required
Ability to work effectively managing CMOs required
Strong planning & organizational skills (and an ability to work to targets, deadlines, and prioritize) required
Proficient in MS Word, Excel, MS Project & PowerPoint required
Understanding of national and international regulatory requirements as it relates to Aseptic Manufacturing required
Proficient in generating and executing protocols and reports required
Novo Nordisk is currently in the process of adjusting job titles globally. Please note that the job title listed in this advertisement may be subject to change. More detailed information will be provided during the recruitment process.
The base compensation range for this position is $148,290 to $259,510. 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.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
We’re not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long‑term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health.
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.
#J-18808-Ljbffr