- To be successful in this role, deep understanding of Process Development is required. You should be able to drive continuous improvement initiatives across biopharmaceutical process development stages.
- Provide internal oversight for all process development activities (cell culture, cell-line banking, protein purification); along with outsourced vendor
- Provide strategic oversight for several programs from discovery, early-stage development, commercialization, and Launch
- Strategic collaboration & support across R&D/CMC, Manufacturing, Quality Operations and Business Development/Commercial
- Experience working cross functionally with senior leadership (QC, Analytical, Manufacturing, Regulatory, Business Development, etc. )
- Past Experience with CHO, HEK-293, or Yeast Fermentation based Process Development
- Experience overseeing outsourced vendors (CDMOs) and internal R&D activities
- Expert authoring and strategically working on IND - BLA/MAA submissions
- M.S or Ph.D. in Bioengineering/Chemical Engineering or a related scientific field w/ ideally 10 or more years of industry experience
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Head of Process Development CMC - Boston, United States - EPM Scientific
Description
Job Description
Job DescriptionHead of Process Development
Greater Boston Area | East Coast
Competitive Compensation + excellent bonus/benefits
Duties and Responsibilities:
Qualifications:
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
Company Description
A 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.\rJob Responsibilities:\r
•\tConducting Post Market Activities and Post Market Surveillance\r
•\tManaging Customer and Product Complaint Investigation programs\r
Education and Experience:\r
•\t1 YR. of experience in a technical role in the medical device/pharma/biotech industry\r
•\tBachelor's degree\r
•\tComputer proficiency
