Head of Chemical and Pharmaceutical Development
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Holbæk
Pharmacosmos is seeking an experienced and highly skilled professional to join their team as the Senior Director / Head of Chemical and Pharmaceutical Development (CMC). The successful candidate will be responsible for leading the chemical, pharmaceutical and analytical development at Pharmacosmos (i.e. CMC broadly).
This is a new role of high strategic importance, which will work closely with R&D on key development projects, with business development on M&A and in-licensing assessment, and with Production and Quality in relation to projects.
It is expected that the new Head of CMC will lead and develop the function according to current and future requirements. Being a small team, the Head of CMC will therefore also take an active approach and be hands on in projects on Pharmacosmos product portfolio aimed at manufacturing and regulatory compliance in close corporation with internal functions and CROs/CMOs.
While the emphasis of the role is on CMC development, the role will also be involved in driving specific larger projects for commercial stage products. This would include driving cross-functional efforts on evaluation, selection, and negotiations with CDMOs and subsequent tech transfers in compliance with cGMP.
Work closely with regulatory affairs teams to ensure timely submission of CMC-related documentation to regulatory authorities. Provide expertise and guidance on regulatory requirements for CMC aspects of drug development.
Oversee quality control processes to ensure the highest product quality and compliance with regulatory standards. Implement and maintain effective quality systems within the CMC department.
This is your chance to embark upon a personal and organizational journey in a dynamic company where your know-how is greatly needed for the future development of Pharmacosmos.
The recruitment process is carried out by Venaris Executive Search. For more information regarding the position, please reach out to Sr. Executive Search Consultant, Lars Nordlund, on +45 3123 3018. All requests will be handled confidentially. If this position is for you, do not hesitate to apply by uploading your CV, please click om the blue bottom top right and apply directly at Venaris - it is not necessary to include a cover letter.
This is a new role of high strategic importance, which will work closely with R&D on key development projects, with business development on M&A and in-licensing assessment, and with Production and Quality in relation to projects.
It is expected that the new Head of CMC will lead and develop the function according to current and future requirements. Being a small team, the Head of CMC will therefore also take an active approach and be hands on in projects on Pharmacosmos product portfolio aimed at manufacturing and regulatory compliance in close corporation with internal functions and CROs/CMOs.
Key responsibillities
Strategic Leadership
- Develop and implement the overall CMC strategy in alignment with the company's business goals.
- Responsible for establishing, managing, and leading the execution of the CMC development plans (activities, timelines, and budgets) for drug substance and drug product at Pharmacosmos.
- Contribute to in-license opportunity evaluations and their fit to company's long-term vision.
Product Development
- Oversee the development of robust CMC strategies for new drug candidates, ensuring alignment with regulatory requirements and business objectives.
- Represent CMC in R&D Committee Meetings and ensure close integration of CMC into R&D project teams.
- Responsible for CMC development of new products from ideas through drug development to full scale production and commercialization.
- Leading evaluation, selection, and negotiations with technical/supply CRO/CMOs and responsible for identifying and contracting with control analytical laboratory sites required to support drug development, and primary liaison with all contractors relevant to chemical and pharmaceutical drug development.
- Collaborate with cross-functional teams to drive the successful transition of products from research to commercialization ensuring optimizing existing processes and products.
Manufacturing and Production
While the emphasis of the role is on CMC development, the role will also be involved in driving specific larger projects for commercial stage products. This would include driving cross-functional efforts on evaluation, selection, and negotiations with CDMOs and subsequent tech transfers in compliance with cGMP.
Regulatory Compliance
Work closely with regulatory affairs teams to ensure timely submission of CMC-related documentation to regulatory authorities. Provide expertise and guidance on regulatory requirements for CMC aspects of drug development.
Quality Control
Oversee quality control processes to ensure the highest product quality and compliance with regulatory standards. Implement and maintain effective quality systems within the CMC department.
Candidate Profile
- Advanced degree in Chemistry, Pharmacy, Chemical Engineering, or related field.
- Proven experience in CMC leadership roles within the pharmaceutical industry.
- Strong scientific and technical skills and in-depth knowledge of drug development processes, regulatory requirements, and quality control.
- Strong leadership, communication, and team-building skills.
- Demonstrated ability to navigate and succeed in a dynamic and fast-paced environment.
Experience in
- Preparing and reviewing regulatory CMC documents.
- Working with external contractors (CRO/CMOs) within CMC development.
- Transferring chemical processes from pilot to commercial scale.
- Preparing patents would be an advantage.
- Utilizing Design of Experiment (DOE) principles would be an advantage.
Skills / Competencies
- High scientific proficiency within pharmaceutical, chemical, and analytical chemistry
- Strong analytical capabilities.
- Strong sense of urgency and determination to drive projects forward.
- Self-driven, eager to innovate and to conceive, plan and execute experiments.
- Ability to interpret data and communicate to key stakeholders to assist with decision making.
- Ability to discuss technical issues at plant staff level as well as with a group of technical peers.
Impact the future development of iron- and carbohydrate-based treatments
This is your chance to embark upon a personal and organizational journey in a dynamic company where your know-how is greatly needed for the future development of Pharmacosmos.
How to apply
The recruitment process is carried out by Venaris Executive Search. For more information regarding the position, please reach out to Sr. Executive Search Consultant, Lars Nordlund, on +45 3123 3018. All requests will be handled confidentially. If this position is for you, do not hesitate to apply by uploading your CV, please click om the blue bottom top right and apply directly at Venaris - it is not necessary to include a cover letter.
Information og data
Denne ledige stilling har jobtypen "Afdelingsleder", og befinder sig i kategorien "Ledelse og personale".
Arbejdsstedet er beliggende i Holbæk.
Jobbet er oprettet på vores service den 21.3.2024, 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
- Holbæk
- Fredag den 26. april 2024
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