Director, Bioprocess / Process Development – Pivotal Drug Substance

Career CategoryProcess DevelopmentJob DescriptionJoin Amgen’s Mission of Serving PatientsAt Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.Director, Bioprocess / Process Development – Pivotal Drug SubstanceWhat you will doIn this leadership role, you will be responsible for the development, characterization, scale‑up, and support of drug substance cell culture and purification processes to enable commercial advancement of programs from Phase II/III through marketing applications. Located in Cambridge, MA and/or Thousand Oaks, CA, you will lead and develop a multi‑site organization of 30+ scientists and engineers while driving program success, safety culture, technical excellence, innovation, automation, and digital strategies.You will support a diverse portfolio of biologics, including monoclonal antibodies (mAbs), BiTEs, bispecifics, biosimilars, and other novel protein‑based modalities, and play a key role in advancing late‑stage and commercial drug substance strategies across Amgen’s manufacturing network.Key ResponsibilitiesLead a high‑impact, multi‑functional 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 Amgen’s scientific and regulatory eminence through publications, patents, and participation in external conferences and forums.Serve as a member of the Drug Substance Technology extended leadership team and contribute to business, organizational, and change‑management strategies.What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications.Basic Qualifications:Doctorate degree and 4 years of scientific process development experience, ORMaster’s degree and 8 years of scientific process development experience, ORBachelor’s degree and 10 years of scientific process development experience AndIn addition to meeting at least one of the above requirements, you must have 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 abovePreferred Qualifications:PhD in Biochemistry, Biochemical Engineering, Chemical Engineering, or related discipline10+ years of experience in biopharmaceutical process developmentMinimum of 4 years of experience directly managing peopleDeep expertise in either cell culture bioreactor processes OR downstream purification processesStrong understanding of late‑stage biologics development including process design, characterization, validation (PPQ), and regulatory interactionsProven ability to provide scientific and engineering leadership on complex cross‑functional programsDemonstrated experience in statistical data analysis, technical decision‑making, and senior‑level communicationTrack record of developing talent through coaching, mentoring, and feedbackActive engagement in the scientific community (publications, patents, industry forums)What you can expect of usAs 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, we’ll support your journey every step of the way.The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accountsA discretionary annual bonus program, or for field sales representatives, a sales-based incentive planStock-based long-term incentivesAward-winning time-off plansFlexible work models where possible. Refer to the Work Location Type in the job post