Head of Chemical and Pharmaceutical Development

at  Pharmacosmos

4300 Holbæk, Region Sjælland, Denmark -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate25 Jun, 2024Not Specified26 Mar, 2024N/ADevelopment Projects,Regulatory Compliance,Cmc,Design,Cmc Development,Decision Making,Chemistry,It,Licensing,AssessmentNoNo
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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