Amgen Process Development Scientist - Pivotal Drug Substance in Cambridge, Massachusetts
Amgen is seeking a Process Development Scientist - Pivotal Drug Substance to join the Pivotal Drug Substance Technologies organization at our Cambridge, MA facility. The Process Development Scientist - Pivotal Drug Substance will report to the Process Development Senior Scientist.
The Process Development Scientist - Pivotal Drug Substance will be responsible for developing cell culture and bioreactor processes for recombinant proteins. This will involve bench and pilot-scale process development activities, data documentation, as well as technology transfer to manufacturing facilities. The Scientist will work in a team environment, collaborating with various colleagues in process and product development/engineering.
As part of an expanding Pivotal Process Development subgroup, the Pivotal Drug Substance Technologies organization at Amgen develops, characterizes and supports the commercialization of the drug substance manufacturing processes for all late-stage programs across the Amgen portfolio.
Responsibilities of the Process Development Scientist - Pivotal Drug Substance include:
Participates in drug substance teams and collaborate cross functionally with analytical and drug product representatives to delivery drug substance manufacturing processes in a phase appropriate manner
Works cross-functionally to deliver CMC regulatory documents and supporting documentation in support of Amgen’s large molecule regulatory filings
Works with external partners to deliver key intermediate or drug substances in support of Amgen’s large molecule pipeline
Delivers processes amenable to cGMP operation and carry out deliveries of drug substance in a cGMP manufacturing environment
Participates on drug substance development teams as a team member or primary department representative
Represents the department in various departmental and interdepartmental committees that address scientific and administrative initiatives
Participates in and can direct team efforts directed at advancing development / technology programs within the department
Applies team experiences to facilitate cohesiveness and build team spirit
Authors, or provides direction for the authorship of technical reports or regulatory submissions which may require minimal additional editing
Gives presentations within the department and to senior management with minimal supervision
Actively creates, generates, and presents paper/presentations at scientific meetings
Organize and conduct meetings
Master’s degree and 3 years of scientific experience
Bachelor’s degree and 5 years of scientific experience
Associate’s degree and 10 years of scientific experience
High school diploma / GED and 12 years of scientific experience
Ph.D. in Chemical Engineering, Biochemistry, Biotechnology, Bioengineering, Biomedical engineering, or Bioprocessing discipline or relevant experience in the pharmaceutical or related industry
Experience in bioreactor process development or cell line development
Scientific understanding of current bioreactor technologies, as well as the ability to explore and develop new approaches to further advance innovative bioreactor technologies
Understanding of protein characteristics and critical attributes so as to direct bioreactor development and product/process control strategies
Independently uncovering and resolving issues associated with cell culture and harvest and implementation of scientific projects
Ability to execute projects as part of a team
Demonstrated collaborative experience and ability to effectively work through others
Strong technical communication skills, both written and verbal, to interact effectively and appropriately with all stakeholders and document learned information, improvements, and value generated
Knowledge of license applications and the drug development process
Exposure to cGMP manufacturing and CMC components of regulatory submissions
Well-recognized in the scientific community through a sustained record of peer-reviewed publications and patents
Leadership experience of progressively increased scope
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and 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.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.