Specialist - Oligonucleotides

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Bagsværd

Are you an experienced scientist with good familiarization of oligonucleotide manufacturing by solid-phase synthesis? Do you want to be process and product owner and participate in late-stage development and life cycle management activities at our contract manufacturing organizations (CMOs)? Then you could be our new colleague in Bagsværd.Apply now for a life-changing career journey and a chance to make a real difference!The position
We are looking for a Sr. Development Scientist / Area Specialist / Specialist (depending on the experience of the candidate) who has a strong scientific and technical background within solid-phase oligonucleotide synthesis at scale.
The preferable candidate is experienced in process chemistry (incl. good knowledge of the typical unit operations for chemical manufacturing at scale) and oligonucleotide chemistry. Experience working in cGMP regulated manufacturing of oligonucleotides is a strong advantage.Your main task will include the following:
  • Take responsibility as the process and product owner for oligonucleotide-based APIs.
  • Take the responsibility as subject matter expert for solid-phase oligonucleotide synthesis in cross-functional projects and ensure that the assigned deliverables in the technical transfer, batch execution/evaluation, process validation and life cycle management activities are timely completed.
  • Provide critical scientific and technical support and troubleshooting for process execution at CMOs, during process implementation and life cycle management and also input on process/equipment changes and deviations
  • Scientific and technical leadership in life cycle management activities, including optimizations, capacity expansions, systematic problem solving, regulatory updates and etc.
  • Author/Co-author, reviewer, and input provider to regulatory registration documents
  • Provide technical and scientific stewardship during process transfer and process implementation at CMOs for solid-phase oligonucleotide manufacturing projects, herein to evaluate, and challenge proposed technical designs, plans, and process setup (e.g. equipment trains, handling, and unit operations).
  • This job gives you a unique opportunity to work with multiple stakeholders including CMC Chemical Development, Analytical Functions, Global Contract Manufacturing (GCM), QA, RA, Sourcing, pilot facilities, production facilities, and external partners. Some travel activities can be expected.
    The position does not involve practical work in the laboratory.Qualifications
    To succeed in the role, we expect that you have:
  • Ph.D. in organic chemistry, chemical engineering or equivalent, preferably with specialization within oligonucleotide chemistry.
  • Experience with chemical manufacturing, preferably with solid-phase synthesis of oligonucleotides
  • High level of relevant GMP experience and understanding of GMP requirements for synthetic APIs
  • Good understanding of unit operations associated with solid phase synthesis. Experience with scale-up and process transfer to large-scale manufacturing is a strong advantage.
  • Good understanding of analytical principles, control strategy and impurity characterization is a strong advantage.
  • Solution-oriented with the strong practical capability to convert theory into practical solutions for technical challenges
  • As an individual, you possess the ability to communicate and collaborate effectively with internal and external stakeholders across various disciplines in development and production. Your positive attitude empowers you to work efficiently, whether as a valuable team player or independently, tackling complex tasks and ensuring timely progress.About the department
    As part of Novo Nordisk’s Product Supply organization, you will be assigned to Emerging Technologies Manufacturing Development (MDev), a cross-functional area currently being established within CMC area. We work at the interface between CMC and full-scale manufacturing with a focus on process understanding, implementation, optimization and life cycle management.
    We offer a very interesting and varying job with the opportunity to work with other highly qualified and motivated colleagues in a multidisciplinary project environment.Working at Novo Nordisk
    At Novo Nordisk, we don’t wait for a 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 to manufacturing, marketing, and sales – we’re all working to move the needle on patient care.Contact
    For further information, please contact Hao Jiang at +45 3448 4222, Director in API Area, Synthetic Platforms and Chemical Entities.Deadline6 August 2023. Applications are reviewed on an ongoing basis, so please submit your application 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 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.
    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.


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    Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".

    Arbejdsstedet er beliggende i Bagsværd.

    Jobbet er oprettet på vores service den 17.7.2023, men kan have været deaktiveret og genaktiveret igen.

    Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
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