Hiring: Director, Bioprocess / Process Development Pivotal Drug Substance Company: BioSpace Location: Cambridge, MA Job Posted Time: 2026-09-11 10:23:45 About the job Experience: •10+ years of experience in biopharmaceutical process development •4 years of experience directly managing people •At least 4 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above Required Skills: •Support a diverse portfolio of biologics, including monoclonal antibodies (mAbs), BiTEs, bispecifics, biosimilars, and other novel proteinbased modalities, and play a key role in advancing latestage and commercial drug substance strategies across Amgens manufacturing network. •Lead a highimpact, multifunctional drug substance organization integrating cell culture and purification disciplines across multiple sites. •Recruit, develop, and retain a strong and diverse team; manage portfolio prioritization and organizational resourcing. •Advance integrated drug substance processes through commercial process development, process characterization, lifecycle management, and control strategy development. •Partner with engineering, manufacturing, and external network collaborators to enable successful process transfer and commercialization. •Author and review global regulatory filings (IND/INDa/MA) and respond to regulatory agency questions. •Drive ideation, development, and deployment of innovative and differentiating bioprocess technologies. •Contribute to Amgens scientific and regulatory eminence through publications, patents, and participation in external conferences and forums. Qualifications: •PhD in Biochemistry, Biochemical Engineering, Chemical Engineering, or related discipline •Minimum of 4 years of experience directly managing people •Deep expertise in either cell culture bioreactor processes OR downstream purification processes •In-depth knowledge of latestage biologics development including process design, characterization, validation (PPQ), and regulatory interactions •Proven ability to provide scientific and engineering leadership on complex crossfunctional programs •Demonstrated experience in statistical data analysis, technical decisionmaking, and seniorlevel communication •Track record of developing talent through coaching, mentoring, and feedback •Active engagement in the scientific community (publications, patents, industry forums) •What You Can Expect Of Us •As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way. Compensation: •Competitive benefits and rewards package Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!