云顶新耀 · CMC

(Senior) Director of mRNA Formulation (DP)

Salary negotiable  /  Working experience not required  /  Shanghai

2024-01-04 Update

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Job Type

  • Recruitment Type:Social Recruitment
  • Work Type:Full-Time

Job descriptions

 Work as a subject matter expert (SME) in mRNA DP process and formulation; provide all kinds of technical support on mRNA DP development and production.

 Manage DP tech transfer, optimization, scale-up, registration batch production and process validation in the manufacture site.

 Monitor project progress in manufacture site or CDMO; solve the technical problem and assure the clinical supply delivery for clinical trials and IND/BLA filings.

 Oversee the plasmid manufacture in CDMO; support the mRNA DS process development and optimization.

 Work closely with cross functions on the project execution and IND/NDA filing to health agency (HA).

 Responsible for mRNA DP commercial supply chains as well.

 Work with CMC Head on mRNA CMC strategy and team build-up.

 Conduct due diligence and provide advice from technical perspective to support license-in programs.

Job qualifications

 Has Ph.D. degree in biochemistry, chemical engineering, pharmaceutical science, or related fields with 8-12 years of industry working experience in big pharma or biotech settings.

 Must be familiar with the mRNA DS, DP process development from early to late stage and to commercialization.

 Has at least 4-6 years of experience in mRNA formulation, DP process development, optimization, scale-up, tech transfer and process characterization.

 Understand the state-of-the-art of formulation technology and analytical characterization tools in mRNA vaccine.

 Have CMC project management experience in mRNA or biologics projects.

 Be familiar with ICH, IMPA, FDA, EMA policies on innovative biologics drug and understand their differences.

 Be familiar with regulatory procedure of IND/BLA filing to IMPA, FDA and EMA.

 Be familiar with IMPD in the CTD format for IND/BLA filing.

 Should be fluent in both English and Mandarin.

Job requirements

  • Degree:PhD
  • Work Experience:Working experience not required
  • Language:Not Required
  • Management Experience:Required