Senior Director, Bioprocess / Process Development Pivotal Drug Substance

Join Amgen's mission of serving patients. 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‑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. Senior Director, Bioprocess / Process Development Pivotal Drug Substance In 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 multisite 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, playing a key role in advancing latest‑stage and commercial drug‑substance strategies across Amgen’s manufacturing network. Key Responsibilities Lead a high‑impact, 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 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. Basic Qualifications Doctorate degree and 5 years of scientific process‑development experience, OR Master’s degree and 9 years of scientific process‑development experience, OR Bachelor’s degree and 11 years of scientific process‑development experience In addition to meeting at least one of the above requirements, you must have at least 5 years of experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Your managerial experience may run concurrently with the required technical experience referenced above. Preferred Qualifications PhD in Biochemistry, Biochemical Engineering, Chemical Engineering, or a related discipline 10+ years of experience in biopharmaceutical process development Minimum of 4 years of experience directly managing people Deep expertise in either cell‑culture bioreactor processes OR downstream purification processes Strong understanding of latest‑stage biologics development including process design, characterization, validation (PPQ), and regulatory interactions Proven ability to provide scientific and engineering leadership on complex cross‑functional programs Demonstrated experience in statistical data analysis, technical decision‑making, and senior‑level 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 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 accounts A discretionary annual bonus program, or for field sales representatives, a sales‑based incentive plan Stock‑based long‑term incentives Award‑winning time‑off plans Flexible work models where possible Amgen is an Equal Opportunity Employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. #J-18808-Ljbffr BioSpace