Development Scientist/Senior Development Scientist - Organic Chemistry
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Bagsværd
Are you highly skilled within classical organic chemistry and/or solid phase peptide synthesis and want to be part of final development activities and process validation activities including providing scientific stewardship for process transfer and implementation at CMOs? Then you could be our new colleague in Bagsværd.
The position
We are looking for a Development Scientist/Senior Development Scientist who has a strong scientific background within classical organic chemistry and/or solid phase peptide synthesis for manufacturing of APIs and/or chemical modification of recombinant peptides and proteins. The preferable candidate is experienced in process chemistry (including process scale-up, process transfer and process implementation at-scale) and/or process characterization and validation. Experience working in cGMP regulated areas and disciplines is an advantage. So, what will you do?
• Support the development of robust chemical processes, process validation activities as well as life cycle management activities during commercial supply
• Support of process transfers and implementation at CMO (GMP production) and/or Novo Nordisk’s facility
• Participate in cross organizational groups and take responsibility for specific tasks in the process transfer to the final production facility
• Generate relevant technical documentation in development reports for use in later regulatory filings and additional work on optimizing existing marketed processes
• Act as process and product SME in cross-functional project to support that all scientific documentation is in place and at the right scientific level before final process validation
• API Process responsible from process validation and onwards
• Process and product owner at Novo Nordisk and provide critical scientific support for processes during validation and commercial phase
• Comment on process changes and deviations
• Author/Co-author, review and input provider to regulatory registration documents
This job gives you a unique opportunity to work with multiple stakeholders including CMC Late-Stage Development, analysis teams, QA, RA, Sourcing, pilot facilities, production facilities, and external partners. Minor travel activities can be expected. The position does not require practical work in the laboratory.
Qualifications
The preferred candidate profile and the desired qualifications are summarized below. Nevertheless, we also encourage applications from less experienced candidates with desire to learn and grow. • PhD or equivalent in synthetic organic chemistry. Alternatively, M.Sc. in organic chemistry with min. 5 years of experience in pharmaceutical industry working with synthetic API manufacturing
• Preferably, experience with cGMP in pharmaceutical industry
• Experience with organic synthesis, preferably a process chemistry
• Innovative and flexible mind-set being able to convert theory into practical solutions
• Able to communicate and collaborate effectively across disciplines in development, production, and with external partners
• Positive attitude with the ability to be both a team player and to work independently on complicated tasks ensuring timely progress
Experience within one or more of the following disciplines are an advantage:
• Experienced within process chemistry, herein scale-up and and process transfer from pilot scale to final production facility
• Experienced with chemical modification of peptides
• Experience within solid phase synthesis, e.g. SPPS
• Solid form science knowledge is an advantage
About the department
As part of Novo Nordisk’s Product Supply organization, Active Pharmaceutical Ingredients (PS API) is responsible for manufacturing of APIs for Novo Nordisk’s products. You will be assigned to Manufacturing Development (MDev), a cross-functional area that works at the interface between R&D and full-scale manufacturing with a focus on process understanding, implementation and optimization. You will be hired into the Specialised Support Department (Synthetic API and Side Chain Reagents), where you will find highly skilled colleagues working within different chemical/synthetic modalities, statistics and modelling.
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, your skills, dedication, and ambition help us change lives for the better. In exchange, we offer unique possibilities for professional and scientific development in state-of-the-art facilities, an informal working environment, and the chance to integrate into a dynamic team of highly qualified and enthusiastic colleagues.
Contact
For further information, please contact Hao Jiang at +45 3448 4222.
Deadline
April 2 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.
The position
We are looking for a Development Scientist/Senior Development Scientist who has a strong scientific background within classical organic chemistry and/or solid phase peptide synthesis for manufacturing of APIs and/or chemical modification of recombinant peptides and proteins. The preferable candidate is experienced in process chemistry (including process scale-up, process transfer and process implementation at-scale) and/or process characterization and validation. Experience working in cGMP regulated areas and disciplines is an advantage. So, what will you do?
• Support the development of robust chemical processes, process validation activities as well as life cycle management activities during commercial supply
• Support of process transfers and implementation at CMO (GMP production) and/or Novo Nordisk’s facility
• Participate in cross organizational groups and take responsibility for specific tasks in the process transfer to the final production facility
• Generate relevant technical documentation in development reports for use in later regulatory filings and additional work on optimizing existing marketed processes
• Act as process and product SME in cross-functional project to support that all scientific documentation is in place and at the right scientific level before final process validation
• API Process responsible from process validation and onwards
• Process and product owner at Novo Nordisk and provide critical scientific support for processes during validation and commercial phase
• Comment on process changes and deviations
• Author/Co-author, review and input provider to regulatory registration documents
This job gives you a unique opportunity to work with multiple stakeholders including CMC Late-Stage Development, analysis teams, QA, RA, Sourcing, pilot facilities, production facilities, and external partners. Minor travel activities can be expected. The position does not require practical work in the laboratory.
Qualifications
The preferred candidate profile and the desired qualifications are summarized below. Nevertheless, we also encourage applications from less experienced candidates with desire to learn and grow. • PhD or equivalent in synthetic organic chemistry. Alternatively, M.Sc. in organic chemistry with min. 5 years of experience in pharmaceutical industry working with synthetic API manufacturing
• Preferably, experience with cGMP in pharmaceutical industry
• Experience with organic synthesis, preferably a process chemistry
• Innovative and flexible mind-set being able to convert theory into practical solutions
• Able to communicate and collaborate effectively across disciplines in development, production, and with external partners
• Positive attitude with the ability to be both a team player and to work independently on complicated tasks ensuring timely progress
Experience within one or more of the following disciplines are an advantage:
• Experienced within process chemistry, herein scale-up and and process transfer from pilot scale to final production facility
• Experienced with chemical modification of peptides
• Experience within solid phase synthesis, e.g. SPPS
• Solid form science knowledge is an advantage
About the department
As part of Novo Nordisk’s Product Supply organization, Active Pharmaceutical Ingredients (PS API) is responsible for manufacturing of APIs for Novo Nordisk’s products. You will be assigned to Manufacturing Development (MDev), a cross-functional area that works at the interface between R&D and full-scale manufacturing with a focus on process understanding, implementation and optimization. You will be hired into the Specialised Support Department (Synthetic API and Side Chain Reagents), where you will find highly skilled colleagues working within different chemical/synthetic modalities, statistics and modelling.
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, your skills, dedication, and ambition help us change lives for the better. In exchange, we offer unique possibilities for professional and scientific development in state-of-the-art facilities, an informal working environment, and the chance to integrate into a dynamic team of highly qualified and enthusiastic colleagues.
Contact
For further information, please contact Hao Jiang at +45 3448 4222.
Deadline
April 2 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.
Information og data
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 8.3.2023, 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.
- Øvrige
- Bagsværd
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