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Chemical/Process Engineer for CMC Chemical Development
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Chemical/Process Engineer for CMC Chemical Development
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Equipment responsible in API purification pilot facility
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Development Scientist
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GMP Material Scientist
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Process Chemistry Scientists - Bagsværd, Danmark - Novo Nordisk
Beskrivelse
The positionWe are looking for Process Chemistry Scientists at all levels (Job seniority depending on the experience of the candidate) who has a strong scientific and/or technical background in organic synthesis and/or GMP manufacturing of chemical entities at scale.
The preferable candidate is experienced in process chemistry (with good knowledge of the typical unit operations for chemical manufacturing at scale) and process engineering.
Experience working in cGMP-regulated chemical manufacturing areas is a strong advantage.Your main task will include the following:
Participate in cross-organizational groups, taking responsibility for deliverables in technical transfer, batch execution/evaluation, process validation, and life cycle management.
Act as process and product owner, serving as a subject matter expert in chemical manufacturing for cross-functional projects, ensuring the completion of technical or GMP documentation at the appropriate level for validation, registration, and life-cycle management activities.
Offer critical scientific and technical support for process execution at CMOs, including troubleshooting and providing input on process and equipment changes and deviations.
Provide technical and scientific stewardship during process transfer, optimization and implementation at CMOs for chemical manufacturing projects, evaluating and challenging proposed technical designs, plans, and process setup.
Support to maintain the validated state of the products, herein regulatory writing, change and deviation management, stability and inspection support.
Collaborate as an author, co-author, reviewer, and input provider for regulatory registration documents.This job gives you a unique opportunity to work with multiple stakeholders including Late-Stage 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 some of the below qualification and is eager to learn any remaining required skillset:
Ph.
D. or M.Sc. in organic chemistry, chemical engineering, or equivalent.
Experience with chemical manufacturing, preferably at pilot plants or commercial manufacturing High level of relevant GMP experience and understanding of GMP requirements for synthetic APIs or bulk pharmaceutical chemicals Knowledge of ICH guidelines relevant for API development, manufacturing, and control.
Knowledge of the principles of process chemistry, and herein a good understanding of unit operations associated with chemical manufacturing, is needed.
Experience with scale-up and process transfer to large-scale manufacturing is a strong advantage.Technical knowledge of equipment design and automation and a good understanding of analytical principles, control strategy, and impurity characterization is a strong advantage.
As a person, you possess a solution-oriented mindset with a strong practical capability to convert theoretical knowledge into practical solutions for technical challenges.
Your ability to communicate and collaborate effectively with internal and external stakeholders across different disciplines in both development and production is highly valuable.
Your positive attitude enables you to work efficiently, whether as a team player or independently, on complicated tasks, ensuring timely progress.
About the department As part of Novo Nordisk's Product Supply organization, you will be assigned to Emerging Technologies API Manufacturing Development (ET API 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.