Senior Project Manager within Drug Substance Development

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Søborg

Do you want to use your professional expertise within recombinant production 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 [xxxxx] 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 recombinant processes, e.g. based on yeast, that can include chemical modification steps. 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 fermentation, purification, chemical modification, 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 biology, biotechnology, biological engineering, chemical engineering or another relevant field within pharmaceutical sciences. Experience within recombinant processes and/or chemical conjugation to peptides or proteins 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 environment About [xxxxx] At [xxxxx], 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 +[xxxxx]. Deadline 16 February 2025 We will review applications and perform interviews on an ongoing basis, so you are encouraged to apply as soon as possible. You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. 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 [xxxxx] 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.


    Information og data

    Denne ledige stilling har jobtypen "Projektleder", og befinder sig i kategorien "Ledelse og personale".

    Arbejdsstedet er beliggende i Søborg.

    Jobbet er oprettet på vores service den 31.1.2025, men kan have været deaktiveret og genaktiveret igen.

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    • Projektleder
    • Søborg
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