Process Development Principal Scientist

Amgen • Thousand Oaks, CA

1d

About The Position

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. R-242409 -Process Development Principal Scientist What you will do Let’s do this. Let’s change the world. In this vital role you will manage an integrated group of cell culture and purification scientists working together to advance Amgen’s rich, exciting and dynamic pipeline. Located at our Thousand Oaks California site, this scientific leadership position will be responsible for the development, characterization, scale-up and support of upstream and downstream drug substance processes to enable commercial advancement of programs. The Pivotal Biologics Drug Substance Process Development organization supports the commercialization of the drug substance manufacturing processes for all late-stage programs across the Amgen portfolio, enabling advancement of programs from Ph II/III clinical trials to marketing application and commercial launch. Lead a group to apply platform approaches and use solid problem-solving skills to rapidly solve development challenges and build robust processes with efficient experimentation. With Amgen’s biology first approach, the position provides the unique opportunity of being able to work on multiple modalities from antibodies and oncolytic viruses to bispecifics and siRNAs. As part of this leadership role, they will develop strong teams and support staff in their career development. Leadership of matrix cross-functional teams that deliver robust drug substance commercialization data packages (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). Drive innovation and use out-of-the-box thinking to lead or support technology advancement efforts at Amgen. Expand Amgen’s external eminence as well as representing Amgen in the external scientific community.

Requirements

• Doctorate degree PhD OR PharmD OR MD and 2 years of scientific experience OR Master’s degree and 5 years of scientific experience OR Bachelor’s degree and 7 years of scientific experience

Nice To Haves

• Doctorate in Chemical Engineering, Biochemical Engineering, or other relevant sciences with 4+ years of experience. Bachelor’s or Master’s degree with 10+ years of relevant industry experience would also be considered.
• Proven track record problem solving and troubleshooting in a process development environment.
• Demonstrated ability to independently identify, develop and implement scientific solutions to practical problems.
• Experience with drug substance commercialization activities, including interactions with regulatory agencies.
• Familiarity with design of experiments and statistical analysis of data.
• Strong expertise in bioprocess development including cell culture, harvest, and purification.
• Track record of innovation.
• Demonstrated eminence in the scientific community through a sustained record of peer reviewed publications and conference presentations.
• 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.
• Proven track record of mentoring and helping staff members reach their potential.

Responsibilities

• manage an integrated group of cell culture and purification scientists working together to advance Amgen’s rich, exciting and dynamic pipeline
• responsible for the development, characterization, scale-up and support of upstream and downstream drug substance processes to enable commercial advancement of programs
• Lead a group to apply platform approaches and use solid problem-solving skills to rapidly solve development challenges and build robust processes with efficient experimentation.
• develop strong teams and support staff in their career development
• Leadership of matrix cross-functional teams that deliver robust drug substance commercialization data packages (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)
• Drive innovation and use out-of-the-box thinking to lead or support technology advancement efforts at Amgen.
• Expand Amgen’s external eminence as well as representing Amgen in the external scientific community.

Benefits

• 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
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees