Head of CMC
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Head of CMC
Unique opportunity of setting up the structure and function of CMC in a growing biotech startup.
The position as Head of CMC is a newly established position and the person will be the first CMC Professional at SNIPR Biome.
It is a unique opportunity to work with the latest technologies in a biotech company that aims to be able to make targeted microbiome engineering with their CRISPR-based precision medicines. SNIPR Biome is in the process of expanding its pipeline with more drug candidates and is putting considerable emphasis on the upcoming clinical development of its own products.
It is a once in a lifetime opportunity to be part of setting up the structure and function of CMC. As Head of CMC, you will be part of the team driving SNIPR’s development projects further. You will play a key role and provide effective support to the organization to ensure the best development programs for the different projects.
With direct report to the COO.
Your main tasks are:
You have a proven record of accomplishment and have more than 5 years of documented professional experience from a CMC position in the Pharma or Biotech industry. Moreover, you have solid experience with GMP manufacturing, QC and/or QA in the field of live biotherapeutic products/phages/live bacteria/vaccines/biologics. You have experience with IND filings as well as thorough knowledge of relevant FDA and EMA regulations (CMC). Experience with managing international GMP CMOs for the manufacture and QC of API and Drug Product is prefered together with experience with implementing technical, strategic, and operational CMC plans. You can secure knowledge transfer across projects and outline the technical part of CMC agreements. Furthermore, you have knowledge of the challenges associated with CMC for this particular field and a proven ability to anticipate issues associated with production that allows to de-risk production of leads. Finally, you have knowledge of batch release assays, experience with managing the CMC/regulatory affairs interface; assay certification experience and experience with formulation design and delivery.
You have a Master’s Degree in Biology, Chemistry, Engineering, Pharmacy, or the like. A PhD is preferred but not a requirement.
You are a person who can work independently and have the experience to make critical decisions. You are comfortable in a dynamic environment in which priorities and drivers can change rapidly. You have clear communication skills towards your stakeholders, with an open and communicative approach and you can develop effective relationships internally as well as externally (CMOs). You thrive in a facilitating project management role and in a science-driven business-oriented environment. You are hands-on, open-minded and you like to have fun. You are robust and able to handle and deliver on routine jobs when necessary together with being persistent and detail-oriented without missing the big picture.
At SNIPR Biome you will be a part of an international, entrepreneurial and informal working environment with the exciting possibility to work in a novel therapeutic area and making a difference.
Travelling: 20 days per year.
Domicile: SNIPR Biome resides in an entrepreneurial office facility with a rooftop terrace and a wonderful view of Copenhagen.
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 Research Consultant Elisabeth Haun, Unique Human Capital on M: +45 28 90 33 88. All applications must be in English and are treated confidentially.
Unique opportunity of setting up the structure and function of CMC in a growing biotech startup.
The position as Head of CMC is a newly established position and the person will be the first CMC Professional at SNIPR Biome.
It is a unique opportunity to work with the latest technologies in a biotech company that aims to be able to make targeted microbiome engineering with their CRISPR-based precision medicines. SNIPR Biome is in the process of expanding its pipeline with more drug candidates and is putting considerable emphasis on the upcoming clinical development of its own products.
It is a once in a lifetime opportunity to be part of setting up the structure and function of CMC. As Head of CMC, you will be part of the team driving SNIPR’s development projects further. You will play a key role and provide effective support to the organization to ensure the best development programs for the different projects.
With direct report to the COO.
Your main tasks are:
- Drive CMC activities
- Liaise with Project Managers and Department Heads (incl. Head of Quality, Head of Assays & In Vitro Biology and Head of In Vivo Pharmacology & Toxicology), to make sure research activities (e.g. transfer of assays, material for in vivo and in vitro) are aligned with CMC activities
- Management of Contract Manufacturing Organizations (CMOs) and CMC relevant vendors
- Ensure GMP process optimization, manufacture, quality control, and supply of investigational medicinal products for clinical trials
- In coordination with the In Vitro Assay Team and Quality, implement appropriate analytical methods and protocols and ensure that all CMOs are using systems and processes in compliance with relevant regulatory standards and GMP
- Writing and reviewing documents for regulatory submissions
- Represent the company as the CMC expert to regulatory authorities
- Prepare, review, and edit GMP batch records, specifications, validations reports, CMC regulatory documents, and other relevant Quality documents
- Provide CMC input to all SNIPR Biome’s research projects
- Collaborate with authorities
- Setting the standard and ensuring continuous improvement and adaptation to the company’s needs from early development through commercialization
You have a proven record of accomplishment and have more than 5 years of documented professional experience from a CMC position in the Pharma or Biotech industry. Moreover, you have solid experience with GMP manufacturing, QC and/or QA in the field of live biotherapeutic products/phages/live bacteria/vaccines/biologics. You have experience with IND filings as well as thorough knowledge of relevant FDA and EMA regulations (CMC). Experience with managing international GMP CMOs for the manufacture and QC of API and Drug Product is prefered together with experience with implementing technical, strategic, and operational CMC plans. You can secure knowledge transfer across projects and outline the technical part of CMC agreements. Furthermore, you have knowledge of the challenges associated with CMC for this particular field and a proven ability to anticipate issues associated with production that allows to de-risk production of leads. Finally, you have knowledge of batch release assays, experience with managing the CMC/regulatory affairs interface; assay certification experience and experience with formulation design and delivery.
You have a Master’s Degree in Biology, Chemistry, Engineering, Pharmacy, or the like. A PhD is preferred but not a requirement.
You are a person who can work independently and have the experience to make critical decisions. You are comfortable in a dynamic environment in which priorities and drivers can change rapidly. You have clear communication skills towards your stakeholders, with an open and communicative approach and you can develop effective relationships internally as well as externally (CMOs). You thrive in a facilitating project management role and in a science-driven business-oriented environment. You are hands-on, open-minded and you like to have fun. You are robust and able to handle and deliver on routine jobs when necessary together with being persistent and detail-oriented without missing the big picture.
At SNIPR Biome you will be a part of an international, entrepreneurial and informal working environment with the exciting possibility to work in a novel therapeutic area and making a difference.
Travelling: 20 days per year.
Domicile: SNIPR Biome resides in an entrepreneurial office facility with a rooftop terrace and a wonderful view of Copenhagen.
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 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 Ø.
Jobbet er oprettet på vores service den 2.9.2020, 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 Ø
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