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.
What you will do
Let’s do this. Let’s change the world. In this vital role, you will work as a Process Development Senior Scientist within Pivotal Drug Product Technologies at Amgen's Process Development hub in Cambridge, MA. This group is responsible for late-stage drug product formulation and process development for biologics modalities (e.g. monoclonal antibodies, bispecific T-cell engagers (BiTEs), and fusion proteins). Working closely with a team of scientists and engineers, the successful candidate will apply scientific and engineering principles to advance the technical aspects of Amgen’s drug product and process development.
Responsibilities:
Participate in Drug Product Commercialization Teams responsible for responsible for conducting process development of pipeline products and for supporting commercial products through lifecycle management
Design, plan, complete, and document formulation and process development studies
Don't want to miss the next one?
Subscribe to daily email alerts for roles matching your interests.
Apply scientific/engineering principles and techniques to develop, characterize and implement processes and next generation technologies and to solve technical challenges
Apply advanced statistical/data analytics techniques to draw conclusions and inform decisions
Provide support, as needed, to clinical and commercial fill/finish manufacturing operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments for process changes/improvements and non-conformance investigations
Author/review guideline documents, technical protocols, reports, product impact assessments, and regulatory sections in support of IND and marketing application submissions
Stay current on the latest developments in the industry and scientific community to continue innovating and to meet future business needs
Effectively and consistently communicate with management, cross-functional partners and relevant team members on progress towards achievements and forthcoming program needs.
Lead cross functional initiatives enhancing Pivotal Drug Product platforms
Manage and contribute to process design improvement projects
Ability to travel domestically and internationally up to 10% of the time
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Scientific professional we seek is an individual with these qualifications.
Basic Qualifications:
Doctorate degree OR
Master’s degree and 3 years of scientific experience OR
Bachelor’s degree and 5 years of scientific experience
Preferred Qualifications:
Advanced Degree in Chemical Engineering, Biochemical Engineering, Mechanical Engineering, Chemistry, Materials Science, Pharmaceutics or related field
Experience in pharmaceutical/biotechnology development and manufacturing
Experience in biologics process development, formulation development, fill-finish process engineering, technical transfers to global manufacturing sites, and statistical design and analysis of experiments
Experience with development and characterization of formulations and drug product manufacturing processes
Experience with unit operation (i.e. filling, filtration, mixing, etc.) specific scale down model development, characterization, and scale-up
Understanding of physical/chemical stability of proteins and how process related stress impacts product quality
Proficiency in at least one statistical software package (e.g. SAS, JMP or Minitab)
Critical thinking, problem solving and independent research skills
Strong project management skills, including the ability to manage one’s project resources (material, workforce, time, etc.)
Good organizational skills with strong attention to detail
Strong ability to operate well in a fast-paced, matrixed environment and collaborate successfully cross-functionally
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 where possible. Refer to the Work Location Type in the job posting to see if this applies.
careers.amgen.com
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.
. Salary Range
Similar roles you might like
More openings like this one — take a look before you go.
