Director/Senior Director Drug Substance Antibodies

1 month ago


Boston MA, United States AL Solutions Full time

DescriptionLead and develop a drug substance team for preclinical through commercialization to support biologics program advancement.Work with internal and external stakeholders to achieve on time targets.Regulatory data creation to author documentation supporting filings and responses to health authorities globally.Manage leadership and operational functions such as budget requirements, mentorship and presentation of project achievement and initiatives to company executives.RequirementsPhD in related area with 10-15 years of industry experience in process development, drug substance and or manufacturing.3-5 years of leadership experience of direct reports and career development of subordinates. Regulatory experience such as contribution to IND, BLA filings, health authority interaction and responses.Successful regulatory filing for biologics strongly preferred.BenefitsCompetitive and flexible salary range.401K plan.Industry leading full coverage health benefits.Flexible PTO and holiday shutdown.Job SummaryID: 39CCBA41C1Department: CMC & Tech OpsType: full time



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