Process Development Senior Principal Scientist

Amgen • Cambridge, MA

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. Process Development Senior 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 Cambridge Massachusetts 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 a wide range of biologics molecules including antibodies, biosimilars, bispecifics, and other novel protein-based modalities. Develop and recruit strong and diverse 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). Ideation, development, and deployment of differentiating technologies and establishing a culture of innovation. Expand Amgen’s external eminence as well as representing Amgen in the external scientific community.

Requirements

• Bachelor’s degree and 8 years of Scientific experience OR Master’s degree and 6 years of Scientific experience OR Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable] and 3 years of Scientific experience
• 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.
• Familiarity with design of experiments and statistical analysis of data.
• Strong expertise in bioprocess development including cell culture, harvest, and purification.
• 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.

Nice To Haves

• Doctorate in Chemical Engineering, Biochemical Engineering, or other relevant sciences with 4+ years of experience OR Bachelor’s or Master’s degree with 10+ years of relevant industry experience.
• Experience with drug substance commercialization activities, including interactions with regulatory agencies.
• 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.
• 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 and recruit strong and diverse 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).
• Ideation, development, and deployment of differentiating technologies and establishing a culture of innovation.
• Expand Amgen’s external eminence as well as representing Amgen in the external scientific community.

Benefits

• 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: Mid Level
• Education Level: Ph.D. or professional degree