Process Development Scientist - Pivotal Drug Product Technologies
HOW MIGHT YOU DEFY IMAGINATION?
Youveearned your degree. How will you use that achievement to reach your goals? Do more with the knowledgeyouveworked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
What you will do
Letsdo this.Letschange the world. In this vital role you will be the liaison to our customers by providing clinical knowledge of our products to medical professionals.
Amgen's medicines treat serious illnesses and our research address diseases with a limited number of treatment options. With a robust and differentiated pipeline, Amgen remains committed to advancing science to dramatically improve people's lives.
Amgen is currently seeking a Process Development Scientist in Pivotal Drug Product Technologies at its 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 Amgens drug product and process development.
The responsibilities of this candidate will include:
- Own the design and planning of laboratory studies related to formulation and fill/finish process development by applying basic science/engineering skills, first principles modeling, and prior knowledge
- Execute and detail laboratory studies with a high degree of technical difficulty
- Develop technical project plans to generate comprehensive data packages in support of commercial formulation/process development and process characterization
- Author and review guideline documents, technical protocols, and reports
- Author and review regulatory sections in support of IND and marketing application submissions
- Manage multiple activities in parallel to drive project plans to completion, meeting project timelines and landmarks
- Participate in Drug Product Commercialization Teams responsible for conducting process development on pipeline and lifecycle management programs
- Perform data analysis using sophisticated statistical/analytical techniques with a proficiency in statistical analysis software
- Deliver progress reports and presentations to management on technical challenges, proposed solutions and results
- 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.
Masters degree and 3 years of Scientific experience
Bachelors degree and 5 years of Scientific experience
Associates degree and 10 years of Scientific experience
High school diploma / GED and 12 years of Scientific experience
- Advanced degree in Chemical Engineering, Biomedical Engineering, Biochemistry, Biotechnology, Pharmaceutics or related subject area
- 2 plus years of post-doctoral or industry experience in pharmaceuticals/biotechnology or related field
- Knowledge of/hands-on experience with formulation and commercial process development for liquid and lyophilized drug products
- 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, specifically, the impact of freezing and drying to short- and long-term stability
- Experience with coding/scripting for automated data analysis and modeling
- Experience with data visualization tools or packages, such as Tableau or Spotfire
- Experience that includes elements of new product development, formulation development, process characterization, equipment design and implementation, technical transfers to global manufacturing sites, statistical process control (SPC), and statistical design and analysis of experiment
- Critical thinking, problem solving and independent research skills
Strong project management skills, including the ability to manage ones project resources (material, manpower, 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.
Some of the vast rewards of workinghere
As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.
Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your careerjourney
A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table andact
Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) onGlassdoor
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
Equal Opportunity Statement
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.
We will ensure that individuals with disabilities are provided a 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 an accommodation.
Amgen is a Fortune 150 company operating in nearly 100 countries around the world, we invest in highly skilled, dedicated and collaborative individuals who are ready to contribute to our mission in meaningful ways and make a difference in the lives of ourpatients
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing,manufacturingand delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.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, or disability status.
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 requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.