Senior Project Manager within Drug Substance Development

Job title:

Senior Project Manager within Drug Substance Development

Company:

Novo Nordisk

Job description

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Accept ClosePress Tab to Move to Skip to Content LinkSearch by KeywordSearch by LocationLoading…CategorySelect how often (in days) to receive an alert:×Select how often (in days) to receive an alert:Senior Project Manager within Drug Substance DevelopmentCategory: Project Management & AgileLocation:Søborg, Capital Region of Denmark, DKDo you want to use your professional expertise within organic chemistry, to drive and impact a variety of early and late-stage drug development projects within Active Pharmaceutical Ingredient (API) processes? Do you have a solid science background and strong project management skills? And do you want to be a part of the Novo Nordisk growth journey?Then apply for this exciting position as senior drug substance Project Manager in the API Project Office within Chemistry, Manufacturing, Control (CMC) development and scaling.The position
You will manage and lead all CMC API project activities through the different stages of clinical development, from Lead Candidate Selection to final regulatory approval, primarily for projects within synthetic organic chemistry, e.g., peptides, small molecules or oligonucleotides.Using your technical expertise, you will:

• Organize process development activities performed in our laboratories or outsourced to a Contract Manufacturing Organization (CMO) – this will typically include synthesis (e.g., by solid-phase or solution phase organic synthesis), purification and drying manufacturing steps
• Establish new API starting materials, planning of pilot scale manufacturing, development of upscaling for full scale manufacturing
• Author regulatory documentation including Clinical Trials Application (CTA) and New Drug Application (NDA)
• Write and compile various internal and external documentation

As an API Project Manager, you will be a member of a CMC Project Core Team and you will lead a sub-project team of subject matter experts (SME’s) focused on the API Development in an engaging and motivating way. The position will also give you the opportunity to collaborate with cross-functional stakeholders within CMC Development and lead the transfer of project activities from our research unit to CMC Development & scaling and eventually to our Product Supply manufacturing unit or to a CMO.Qualifications
As a minimum you have a M.Sc. (preferably a Ph.D.) in synthetic organic chemistry, chemical engineering, or another relevant field within pharmaceutical sciences. Experience within small molecules is considered an advantage.In addition, the preferred candidate has:

• Minimum 5 years of experience working with API process development and/or manufacturing in a GxP regulated environment. Experience working with external contract manufacturers is a benefit
• The ability to manage competing timelines and priorities
• Strong problem-solving and organizational skills
• Excellent written and verbal communication skills with expert proficiency level using Microsoft Word, Excel, and PowerPoint
• Experience with project management in a multidisciplinary organization is required, including cross-functional communication and stakeholder management, project planning, risk management, and deliverable tracking

You have a high level of energy to drive your projects and engage your colleagues. You are result-oriented and take pride in delivering on your milestones, and you motivate your colleagues with a positive, forthcoming attitude. You can function independently as well as in a team-based environment.
You must have fluency in written and spoken English. Options to learn the Danish language are available.About the department
CMC API Project Office is part of Chemistry, Manufacturing & Control (CMC) API Development and consists of approximately 25 highly skilled and motivated employees located in Søborg, Denmark. The department is involved in the entire CMC API portfolio of development projects moving through the clinical phases from early to late-stage API development and production of new synthetic, semi-recombinant or recombinant API candidates. We strive to have a high level of scientific knowledge and a helpful and pleasant working environmentAbout Novo Nordisk
At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care.Contact
For further information, please contact Dennis Jul Hansen, Manager at +45 34485389.Deadline
16 February 2025We will review applications and perform interviews on an ongoing basis, so you are encouraged to apply as soon as possible.To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.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.

Expected salary

Location

Søborg, Hovedstaden

Job date

Sun, 02 Feb 2025 04:21:52 GMT

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