Process Development Principal Scientist Full-time

Process Development Principal Scientist

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. 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.

The Pre-Pivotal Drug Substance Technologies organization at Amgen develops, characterizes, and supports clinical drug substance manufacturing processes for all early-stage programs in the Amgen portfolio.

The Principal Scientist will manage an integrated group of cell culture and purification scientists working together to advance Amgen's rich, exciting and dynamic pipeline, and provide scientific and strategic leadership for the organization. Located at our Thousand Oaks, CA site, this leadership position will be responsible for the development, characterization, scale-up and support of upstream and downstream drug substance processes to enable clinical advancement of programs.

The successful candidate will lead the group to apply platform approaches and utilize solid problem-solving skills to rapidly solve development challenges and build robust processes with efficient experimentation. As part of this leadership role, you will develop strong teams and support staff in their career development.

Working closely with Research, Attribute Sciences, Drug Product Technologies, Clinical Manufacturing, and partners in the Amgen network, this role will also require leadership of matrix cross-functional teams that deliver robust drug substance data packages for clinical advancement (including authoring of CMC sections of regulatory documents, interaction with regulatory agencies, support of technology transfers and working with various contract development and manufacturing organizations). With Amgen's biology first approach, the position provides the unique opportunity of being able to work on multiple modalities from monoclonal antibodies to bi-specifics and multi-specifics and ADCs.

Additionally, the candidate will drive innovation and utilize out-of-the-box thinking to lead or support technology advancement efforts as well as business initiatives at Amgen. Expanding Amgen's external eminence as well as representing Amgen in the external scientific community would be other expectations.

What We Expect Of You

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.

Basic Qualifications:

• Bachelor's degree and 7 years of Scientific experience OR
• Master's degree and 5 years of Scientific experience OR
• Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable] and 2 years of Scientific experience

Preferred Qualifications:

• Doctorate in Chemical Engineering, Biochemical Engineering, Life Sciences, or other relevant sciences with 4+ years of experience
• Proven track record problem solving and trouble-shooting in a process development environment; Demonstrated ability to independently identify, develop and implement scientific solutions to practical problems
• Advanced understanding of cell culture and or purification techniques, bioreactor production, harvest operations, protein chromatography, TFF, filtration, etc.
• Experience with drug substance commercialization activities, including interactions with regulatory agencies; Familiarity with design of experiments and statistical analysis of data
• Track record of innovation; Demonstrated eminence in the scientific community through a sustained record of peer reviewed publications
• Motivated self starter with excellent interpersonal and organizational skills; Excellent verbal communication and scientific writing 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 success working with diverse team members in a dynamic, cross-functional environment

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, 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 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, including remote and hybrid work arrangements, where possible

Apply now and make a lasting impact with the Amgen team.