Process Development Senior Scientist

BioSpace; Cambridge (MA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Retirement plan

Medical, dental, vision coverage

Life and disability insurance

Flexible spending accounts

Stock-based incentives

Flexible work models

Job summary

Amgen in the United States seeks a Process Development Senior Scientist to lead development, characterization, scale-up and support of drug substance processes enabling program progression from Phase II/III to filing.

You will collaborate with cell culture and purification scientists across modalities to advance Amgen's rich pipeline, delivering robust processes in a regulated, cGMP environment and contributing to regulatory documentation.

Qualifications

• PhD or MSc with Life Sciences experience; strong biology/bioprocess background.
• Experience in bioreactor process development or cell line development.
• Knowledge of DOE and statistical data analysis.
• Exposure to cGMP manufacturing and regulatory submissions (CMC).

Responsibilities

• Develop, characterize, scale-up and support drug substance processes.
• Collaborate with cell culture and purification Scientists to advance programs.
• Contribute to technology development and process improvements.
• Deliver processes in a phase-appropriate manner for cGMP operation.
• Prepare technical reports and contribute to CMC regulatory submissions.

Skills

Technical communication

Leadership

Experiment design

Statistical analysis

Problem solving

Cross-functional collaboration

Education

Doctorate degree

Masters degree + Life Sciences experience

Bachelors degree + Life Sciences experience

Job description

Join Amgen's Mission of Serving Patients

At 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.

Process Development Senior Scientist

What You Will Do

Let's do this. Let's change the world. In this vital role you will be responsible for development, characterization, scale‑up and support of drug substance processes to enable commercial advancement of programs from Phase II/III clinical trials to marketing application.

Work in a coordinated group in which cell culture and purification scientists work together to advance Amgen's rich, exciting and dynamic pipeline. With Amgen's biology‑first approach, the position provides the outstanding opportunity of being able to work on multiple modalities from antibodies and oncolytic viruses to bispecifics and siRNAs.

The Pivotal Drug Substance Process Development organization at Amgen develops, characterizes and supports the commercialization of biologics drug‑substance manufacturing processes for all late‑stage programs across the Amgen portfolio.

• Apply established platform approaches and problem‑solving skills to rapidly tackle drug substance challenges and build robust processes with efficient experimentation
• Drive innovation and utilize out‑of‑the‑box thinking to contribute to technology development
• Expand and develop skills in cell culture and purification, thereby further contributing to the integrated group
• Participate in drug substance teams and collaborate cross functionally with analytical and drug product representatives to deliver drug substance manufacturing processes in a phase‑appropriate manner.
• Deliver process amenable to cGMP operation and carry out results of drug substance in a cGMP manufacturing environment
• Author, or provide direction for the authorship of, technical report or CMC regulatory submissions which may require minimal additional editing

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
• OR
• Masters degree and 2 years of Life Sciences experience
• OR
• Bachelors degree and 4 years of Life Sciences experience

Preferred Qualifications

• Ph.D. in Chemical Engineering, Biochemistry, Biotechnology, Bioengineering, Biomedical engineering, or Bioprocessing discipline or relevant experience in the pharmaceutical or related industry
• Experience in bioreactor process development or cell line development
• Scientific understanding of current bioreactor technologies, as well as the ability to explore and develop new approaches to further advance innovative bioreactor technologies
• Understanding of protein characteristics and critical attributes so as to direct bioreactor development and product/process control strategies
• Independently uncovering and resolving issues associated with cell culture and harvest and implementation of scientific projects
• Strong technical communication skills, both written and verbal, to interact effectively and appropriately with all stakeholders and document learned information, improvements, and value generated
• Motivated self‑starter with excellent interpersonal and organizational skills
• Leadership experience of progressively increased scope and a demonstrated ability to inspire and lead a group of scientists to deliver on complex and challenging objectives in defined timelines
• Demonstrated eminence in the scientific community through a sustained record of peer reviewed publications
• Demonstrated success working with diverse team members in a dynamic, cross‑functional environment
• Familiarity with design of experiments and statistical analysis of data
• Knowledge of license application and the drug development process
• Exposure to cGMP manufacturing and CMC components of regulatory submissions

What you can expect from 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, we 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 toward 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.

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.

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. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.