Director CMC
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Director CMC
Lead the formulation development activities for Orphazyme’s current and future pipeline
https://uhc.dk/wp-content/uploads/2020/12/Director_CMC_Orphazyme.mp4
This is your opportunity to join a dedicated team of professionals and become an important part of the Global Technical Operations team in a progressive and innovative Danish biopharmaceutical company based in Copenhagen.
As Director CMC at Orphazyme, you are expected to create a good understanding of CMC deliverables in the project teams and to establish a close and high-standard cooperation with the CDMOs used by Orphazyme. You will have the opportunity to put your pharmaceutical skills into play by leading the formulation development activities for the current and future pipeline of products. You will work closely with multiple stakeholders, internal as well as external, to ensure that the ambitious goals are met.
You will report directly to the Senior Director, Global Head of CMC and SRM. With your strong project management skills, you will manage Orphazyme’s pharmaceutical development projects ensuring that goals and timelines are met, and that the project organization and leadership is well informed about progress, risks, and deadlines.
The main responsibilities are:
Ideally, you hold a Master’s degree, possibly with a Ph.D., within pharmaceutical sciences or similar with a strong relevant industry experience.
The successful applicant will have a solid theoretical background within pharmaceutical sciences and formulation development, complemented by hands-on experience from years in the laboratory working on the development of oral dosage forms of small molecules. Moreover, you have a good track-record of solutions to challenging projects. You are familiar with vendor management and negotiations. You have at least 5+ years of experience from a similar role.
You are proficient in English on a professional level, both written and spoken.
You have a personal commitment to delivering results. You are analytical and science-driven, and you identify and resolve problems in a timely manner. You are a flexible, adaptable and robust person with a hands-on attitude. You are pragmatic with an open and communicative approach and with the ability to develop effective working relationships with employees at all levels. You are able to and have the routine to work independently, while at the same time having the ability to move projects forward.
Orphazyme offers you an exciting and challenging position in an entrepreneurial, science driven and international company with a short line of command. You will be involved in activities that are central to Orphazyme’s strategy and work together with highly skilled and experienced colleagues to advance the exciting product pipeline.
Travelling: 20 days/year.
Domicile: Ole Maaløes Vej 3, DK-2200 Copenhagen N.
For more details about the job or the company, please contact CEO Jørn Duhn, Unique Human Capital on M: +45 21 75 19 25 or Senior Research Consultant Elisabeth Haun, Unique Human Capital on M: +45 28 90 33 88. All applications must be in English and are treated confidentially.
Lead the formulation development activities for Orphazyme’s current and future pipeline
https://uhc.dk/wp-content/uploads/2020/12/Director_CMC_Orphazyme.mp4
This is your opportunity to join a dedicated team of professionals and become an important part of the Global Technical Operations team in a progressive and innovative Danish biopharmaceutical company based in Copenhagen.
As Director CMC at Orphazyme, you are expected to create a good understanding of CMC deliverables in the project teams and to establish a close and high-standard cooperation with the CDMOs used by Orphazyme. You will have the opportunity to put your pharmaceutical skills into play by leading the formulation development activities for the current and future pipeline of products. You will work closely with multiple stakeholders, internal as well as external, to ensure that the ambitious goals are met.
You will report directly to the Senior Director, Global Head of CMC and SRM. With your strong project management skills, you will manage Orphazyme’s pharmaceutical development projects ensuring that goals and timelines are met, and that the project organization and leadership is well informed about progress, risks, and deadlines.
The main responsibilities are:
- Manage several formulation development projects, including budget, risks and timelines, in cross-functional teams
- Primary scientific contact to the external formulation development partners (CDMOs) with whom you will work to design the work packages and deliverables of the projects
- Review test results in alignment with the project goals and recommend solutions to identified issues together with the CDMO
- To be directly involved in designing of the experimental program together with the CDMOs, while applying QbD principles to achieve optimal products with the desired target profile, ready for scale-up to clinic and commercial
- Guide, support, and co-ordinate with the rest of CMC group in the smooth transfer of products from lab to manufacturing scale
- Lead the writing of required regulatory development documentation for IND/IMPD (3.2.P.2) and other regulatory filing documents
- Secure knowledge transfer across projects
Ideally, you hold a Master’s degree, possibly with a Ph.D., within pharmaceutical sciences or similar with a strong relevant industry experience.
The successful applicant will have a solid theoretical background within pharmaceutical sciences and formulation development, complemented by hands-on experience from years in the laboratory working on the development of oral dosage forms of small molecules. Moreover, you have a good track-record of solutions to challenging projects. You are familiar with vendor management and negotiations. You have at least 5+ years of experience from a similar role.
- Experience with at least one CMC project conducted through more than one clinical development phase. Experience with phase II/III is an advantage
- Experience with project management of multi-functional project teams
- Experience with outsourcing of development and GMP manufacturing activities
You are proficient in English on a professional level, both written and spoken.
You have a personal commitment to delivering results. You are analytical and science-driven, and you identify and resolve problems in a timely manner. You are a flexible, adaptable and robust person with a hands-on attitude. You are pragmatic with an open and communicative approach and with the ability to develop effective working relationships with employees at all levels. You are able to and have the routine to work independently, while at the same time having the ability to move projects forward.
Orphazyme offers you an exciting and challenging position in an entrepreneurial, science driven and international company with a short line of command. You will be involved in activities that are central to Orphazyme’s strategy and work together with highly skilled and experienced colleagues to advance the exciting product pipeline.
Travelling: 20 days/year.
Domicile: Ole Maaløes Vej 3, DK-2200 Copenhagen N.
For more details about the job or the company, please contact CEO Jørn Duhn, Unique Human Capital on M: +45 21 75 19 25 or Senior Research Consultant Elisabeth Haun, Unique Human Capital on M: +45 28 90 33 88. All applications must be in English and are treated confidentially.
Information og data
Denne ledige stilling har jobtypen "Afdelingsleder", og befinder sig i kategorien "Ledelse og personale".
Arbejdsstedet er beliggende i København N.
Jobbet er oprettet på vores service den 2.12.2020, 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.
- Afdelingsleder
- København N
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