Head of Chemical and Pharmaceutical Development
at Pharmacosmos
4300 Holbæk, Region Sjælland, Denmark -
Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
---|---|---|---|---|---|---|---|
Immediate | 25 Jun, 2024 | Not Specified | 26 Mar, 2024 | N/A | Development Projects,Regulatory Compliance,Cmc,Design,Cmc Development,Decision Making,Chemistry,It,Licensing,Assessment | No | No |
Required Visa Status:
Citizen | GC |
US Citizen | Student Visa |
H1B | CPT |
OPT | H4 Spouse of H1B |
GC Green Card |
Employment Type:
Full Time | Part Time |
Permanent | Independent - 1099 |
Contract – W2 | C2H Independent |
C2H W2 | Contract – Corp 2 Corp |
Contract to Hire – Corp 2 Corp |
Description:
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.
Responsibilities:
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.
REQUIREMENT SUMMARY
Min:N/AMax:5.0 year(s)
Pharmaceuticals
Pharma / Biotech / Healthcare / Medical / R&D
Clinical Pharmacy
Graduate
Proficient
1
4300 Holbæk, Denmark