Senior PM & Process Specialist — Pharma CMO Mfg

Ascendis Pharma; Hellerup; On-site; DKK 900,000 - 1,100,000; Full time

Job summary

Ascendis Pharma is seeking a (Senior) Project Manager or Process Specialist to lead outsourced commercial manufacture of peptides, starting materials, intermediates and APIs, including technology transfer, PPQ and CPV. You will report to the Senior Director Birgitte M.

Malle and join the Hellerup-based Chemical Manufacturing team. Requirements include a Master/PhD in chemistry or related field with 5+ years in pharma development or manufacturing, GMP experience, strong English, and proficiency

Qualifications

• Master of Science or Ph.D. in organic chemistry, peptide synthesis, chemical engineering or equivalent; at least 5 years in pharmaceutical development or manufacturing.

Responsibilities

• Manage and coordinate outsourced commercial manufacture of peptides, starting materials, intermediates and APIs including technology transfer, PPQ, CPV.
• Trouble shooting with CMOs, including Deviation and Change management as SME
• Support master batch record update and release of batches with QA
• Write and support regulatory submissions for marketing approval and post-approval

Skills

GMP experience

Proficient English

MS Office with SAS JMP

Education

Master of Science or Ph.D. in organic chemistry / peptide synthesis / chemical engineering

Tools

SAS JMP

Job description

Ascendis Pharma is seeking a (Senior) Project Manager or Process Specialist to lead outsourced commercial manufacture of peptides, starting materials, intermediates and APIs, including technology transfer, PPQ and CPV. You will report to the Senior Director Birgitte M.

Malle and join the Hellerup-based Chemical Manufacturing team. Requirements include a Master/PhD in chemistry or related field with 5+ years in pharma development or manufacturing, GMP experience, strong English, and proficiency