Director/Sr. Director

6 days ago


Boston, United States EPM Scientific Full time
Job DescriptionJob Description

Director/Sr. Director - Process Development
Greater Boston Area
Competitive Compensation + excellent bonus/benefits

Duties and Responsibilities:

  • Lead all process development activities (cell culture/banking/development, fermentation, protein purification, tech transfers)
  • Oversee internal(in-house) and external vendors (domestic & international CDMOs)
  • Work cross-functionally with CMC & Manufacturing leaders such as Analytical, Drug Product, QA/QC, Manufacturing, Supply Chain, etc.
  • Author, review and strategically impact CMC sections (Pre-IND, IND, BLA, & MAA submissions)
  • Manage upstream and downstream scientist

Qualifications:

  • M.S or Ph.D. in Pharmaceutical Sciences or a related scientific field w/ ideally 10 or more years of industry experience & prior management experience
  • Experience working cross functionally with senior leadership (QC, Analytical, Manufacturing, Regulatory, Business Development, etc. )
  • Experience overseeing outsourced vendors (CDMOs) and internal R&D activities
  • Expert authoring and strategically working on IND/IMPD - BLA/MAA submissions
  • Exposure to several modalities is highly sought after (mAbs, ADCs, fusion proteins, VLPs, & Vaccines)
Company DescriptionA top 10 pharmaceutical company with an immense amount of growth after releasing their at home COVID diagnostic tests is looking to bring on 200+ Quality Individuals through a massive hiring campaign. In their search for Quality Specialists, the organization is looking for individuals who will be responsible for reviewing and actioning customer complaints, as well as investigation into said complaints.
Job Responsibilities:
•\tConducting Post Market Activities and Post Market Surveillance
•\tManaging Customer and Product Complaint Investigation programs
Education and Experience:
•\t1 YR. of experience in a technical role in the medical device/pharma/biotech industry
•\tBachelor's degree
•\tComputer proficiency

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