Director, Bioprocess & Process Development - Lead & Scale-Up

BioSpace; Cambridge (MA); On-site; USD 180,000 - 260,000; Full time

Benefits offered by this job

Comprehensive benefits

Discretionary bonus

Stock-based incentives

Flexible work models

Job summary

Amgen in Cambridge, MA, is seeking a Director of Bioprocess/Process Development to lead cell culture and purification efforts from late-stage programs to commercialization across multiple sites. You will build and mentor a 30+ scientist/engineer team, shape process characterization, lifecycle management, and regulatory interactions, while advancing innovative bioprocess technologies.

This role offers broad impact, collaboration with manufacturing, and opportunities to guide strategic decisions

Qualifications

• Doctorate or master's degree with extensive process development leadership.
• Experience managing teams, projects, or programs.
• Experience with cell culture bioreactor or downstream purification.
• Strong data analysis and scientific leadership capabilities.
• Experience with regulatory interactions and filings.

Responsibilities

• Lead a multifunctional drug substance organization across sites.
• Recruit, develop, and retain a diverse team; manage portfolio and resources.
• Advance process development, characterization, lifecycle management, and control strategy.
• Partner with engineering, manufacturing, and external collaborators for process transfer.
• Author and review regulatory filings and respond to regulatory questions.
• Drive ideation and deployment of innovative bioprocess technologies.
• Contribute to Amgen's scientific and regulatory eminence through publications and patents.
• Serve on Drug Substance Technology leadership and contribute to strategy.

Skills

Leadership and people management

Scientific process development

Cell culture and purification

Cross-functional collaboration

Regulatory filings experience

Biopharmaceutical production

Education

PhD in Biochemistry / Biochemical Engineering / related

MS in related field

BS with extensive experience

Job description

Amgen in Cambridge, MA, is seeking a Director of Bioprocess/Process Development to lead cell culture and purification efforts from late-stage programs to commercialization across multiple sites. You will build and mentor a 30+ scientist/engineer team, shape process characterization, lifecycle management, and regulatory interactions, while advancing innovative bioprocess technologies.

This role offers broad impact, collaboration with manufacturing, and opportunities to guide strategic decisions