Director, Bioprocess / Process Development Pivotal Drug Substance

BioSpace; Cambridge (MA); On-site; USD 190,000 - 280,000; Full time

Benefits offered by this job

Retirement plan

Medical insurance

Dental insurance

Vision coverage

Life and disability insurance

Flexible spending accounts

Annual bonus

Stock-based incentives

Time-off programs

Flexible work models

Job summary

Amgen seeks a Director of Bioprocess/Process Development to lead a multi-site drug substance organization, advancing cell culture and purification programs from Phase II/III through commercialization. Based in Cambridge, MA or Thousand Oaks, CA, you will guide a 30+ person team, emphasizing safety, innovation, and digital strategies.

You will oversee biologics programs including mAbs and biosimilars, drive process development, technology transfer, and lifecycle management while collaborating

Qualifications

• PhD or Master/ Bachelor with extensive leadership in biotech process development.
• Experience leading multi-site teams and complex cross-functional programs.
• Strong track record in process development for biologics and regulatory interactions.

Responsibilities

• Lead a high-impact drug substance organization across sites.
• Recruit, develop, and retain a diverse team; manage capacity and resources.
• Advance drug substance processes from development to lifecycle management and transfer.
• Partner with engineering, manufacturing, and external collaborators for tech transfer.
• Author/regulatory filings and respond to agency questions.
• Drive bioprocess tech advances and innovative platforms across Amgen networks.
• Contribute to scientific eminence through publications and patents.

Skills

Bioprocess development

Leadership

Process development

Cell culture

Regulatory filings

Cross-functional leadership

Team management

Education

PhD in Biochemistry/Biochemical Eng/Chemical Eng

Job description

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll 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 Substance

What you will do

In this leadership role, you will be responsible for the development, characterization, scaleup, 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 proteinbased modalities, and play a key role in advancing latestage and commercial drug substance strategies across Amgens manufacturing network.

Key Responsibilities

• 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.
• Serve as a member of the Drug Substance Technology extended leadership team and contribute to business, organizational, and changemanagement strategies.

What we expect of you

We 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, OR
• Masters degree and 8 years of scientific process development experience, OR
• Bachelors degree and 10 years of scientific process development experience And
• In 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 above

Preferred Qualifications

• PhD in Biochemistry, Biochemical Engineering, Chemical Engineering, or 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 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.

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 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. Refer to the Work Location Type in the job posting to see if this applies.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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.

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.