HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you're part of something bigger, it's because
you are. At Amgen, our shared mission-to serve patients-drives all
that we do. It is key to our becoming one of the world's leading
biotechnology companies. We are global collaborators who achieve
together-researching, manufacturing, and delivering ever-better
products that reach over 10 million patients worldwide. It's time
for a career you can be proud of. Join us.
Process Development Senior Scientist
What you will do
Let's do this. Let's change the world.
Amgen discovers, develops and delivers innovative human
therapeutics. A biotechnology pioneer since 1980, Amgen was one of
the first companies to realize the new science's promise by
bringing safe, effective medicines from lab, to manufacturing
plant, to patient. Amgen therapeutics have changed the practice of
medicine, helping millions of people around the world in the fight
against cancer, kidney disease, rheumatoid arthritis, and other
serious illnesses. With a deep and broad pipeline of potential new
medicines, Amgen remains committed to advancing science to
dramatically improve people's lives.
Amgen's Commercial Attribute Sciences group in Thousand Oaks, CA
is seeking a leader. The successful candidate will be responsible
for leading a team of scientists to provide technical oversight in
support of method related testing challenges, incoming method
transfer and commercial investigations spanning various analytical
platforms which may include Chromatography, CE, General Assays
(e.g. pH, Osmolality, Karl Fisher titration, etc.), Gels, Bioassays
and Immunoassays used to test diverse modalities including
monoclonal and bispecific antibodies, bispecific T-cell engagers
("BiTEs"), synthetic peptides and live oncolytic viruses.
Responsibilities also include supporting implementation of new
analytical technology, incoming tech transfer, and management of
Commercial ASTLs (Attribute Sciences Team Leads). The successful
candidate will be a part of a team at the interface with Commercial
Quality, Manufacturing, Drug Product Process Development, and
Contract Manufacturing, liaising with the global Attribute Sciences
network to ensure that site needs are addressed. This leadership
role of the Commercial Attribute Sciences team at Thousand Oaks
will laisse with site leadership as well as Attribute Sciences
functional leadership across Amgen.
Technical leadership in support of troubleshooting method
related testing challenges, incoming method transfer and commercial
Independent authorship and management review of technical
reports, variations and responses to analytical questions from
Implementing state-of-the-art and fit-for-purpose analytical
methods for: release testing, stability testing, product
characterization/optimization, investigations, and regulatory
Generating, analyzing, and critical evaluation of analytical
data to support product development investigations, method
remediation and regulatory submissions
Supporting ASTLs (May participate or contribute to critical
analytical development teams (e.g., Product and process development
teams, Product quality teams) by providing analytical updates,
analytical documentation and data interpretation
Supporting career development and mentoring staff
Duties may include establishing timelines, milestones,
methodological approaches, expected results, necessary resources
and communication to global cross-functional stakeholders
- Keeping current in the analytical development field including
literature and technology development for cutting edge and
regulatory driven activities.
What we expect of you
We are all different, yet we all use our unique contributions to
serve patients. The scientific leader we seek is a collaborative
team-player with these qualifications.
Doctorate degree and 2 years of scientific experience
Master's degree and 5 years of scientific experience
Bachelor's degree and 8 years of scientific experience
PhD in Analytical Chemistry, Organic Chemistry, Materials
Science, Biochemistry, Biochemical or Chemical Engineering
5+ year's pharmaceutical/biotech experience in process and
product development and analytical method development
Deep understanding of product quality attributes and control
strategies, quality attribute assessments, and Quality Target
Product Profile throughout the lifecycle of a product.
Commanding knowledge of analytical methods/technologies such as
Chromatography, CE, General Assays (e.g. pH, Osmolality, Karl
Fisher titration, etc.), Gels, Bioassays and Immunoassays used to
test diverse modalities including monoclonal and bispecific
antibodies, bispecific T-cell engagers ("BiTEs"), synthetic
peptides and live oncolytic viruses
Experience with developing, implementing and commercializing
methods for in-process testing, process characterization, release
and stability testing.
Strong understanding of regulatory expectations related to
analytical control strategies, familiar with applicable US and
worldwide regulatory requirements.
Strong understanding of drug substance and drug product
Experience with regulatory filings and commercial quality
Experience working closely with process engineers and quality
control laboratories to generate and interpret analytical data to
provide enhanced understanding and guidance around process
understanding and control
Experience with QbD and PAT, as applied to pharmaceutical
Experience managing and transferring commercial production and
Experience managing a team
- Strong communication skills and ability to provide
cross-functional leadership and guidance to CMC and non-clinical
teams, e.g. advising and defending the Quality Target Product
What you can expect of us
As we work to develop treatments that take care of others, so we
work to care for our teammates' professional and personal growth
Vast opportunities to learn and move up and across our global
Diverse and inclusive community of belonging, where teammates
are empowered to bring ideas to the table and act
- Generous Total Rewards Plan comprising health, finance and
wealth, work/life balance, and career benefits
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.
If 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
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.