Process Development Associate
- Employer
- Amgen
- Location
- Thousand Oaks, CA
- Start date
- Nov 29, 2022
View more
- Discipline
- Engineering, Manufacturing & Production, Process
- Required Education
- High School or equivalent
- Position Type
- Full time
- Hotbed
- Biotech Beach, Best Places to Work
Job Details
HOW MIGHT YOU DEFY IMAGINATION?
Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? 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. Come do your best work alongside other innovative, driven professionals in this meaningful role.
LiveWhat you will do
Lets do this! Lets change the world!
Attribute Sciences group within Process Development provides scientific and technical expertise to support development and commercialization of Amgens pipeline of drug candidates. The department identifies and coordinates the achievement of desired product quality attributes towards target product profiles, develops and applies fit-for-purpose analytical methodologies. This position is an exciting opportunity to be a part of Amgen. Our culture encourages open communication to help our staffs to excel throughout their career at Amgen. Amgen focuses on areas of high unmet medical needs and uses its expertise to strive for solutions that improve health outcomes and dramatically improve peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Amgen Process Development (PD) organization is seeking an enthusiastic team-oriented Associate. The successful candidate will be responsible for providing technical assessments using color, clarity, visual, pH, osmolality, density, concentration, solid state extraction, HIAC, Karl-Fisher techniques for early phase GMP biologic materials and supporting troubleshooting method related issues, transferring method into an early phase GMP laboratory, and delivering attribute characterization data in a compliance manner. The candidate should have proven skills and extensive experiences in color, clarity, visual, pH, osmolality, density, concentration, solid state extraction, HIAC, Karl-Fisher analytical methods used to test diverse modalities including monoclonal, bispecific antibodies, bispecific T-cell engagers (BiTEs), and other protein modalities. This individual will be a part of a team that collaborates with early phase and late phase attribute sciences development teams.
Compendial GxP responsibilities include, but are not limited to, the following:
Work as an analyst to support product release and stability Compendial Assay testing in compliant with cGMP regulations.
Document, analyze, and report results.
Follow Standard Operating Procedure (SOPs) under direction of a Technical Supervisor.
Author, review, and data verify technical documents.
Analytical laboratory skills and technical knowledge of proteins and peptides.
Experience with cGMP and/or QC environment, documentation and methods.
Experience with the following techniques: color, clarity, visual, pH, osmolality, density, concentration, solid state extraction, HIAC, Karl-Fisher.
Experience in working with LIMS is a plus.
Collaborative personality and acute attention to detail.
Good troubleshooting and problem solving skills.
Good verbal communication, organization, presentation, and technical writing skills.
Ability to work and adapt in a fast-paced and dynamic environment
Document, review results, and maintain electronic laboratory notebooks
Work with development team to implement methods, analyze and interpret data
Solve technical problems with both instrument and assay issues as part of troubleshooting
Author, review, and data verify technical documents
Communicate project updates as appropriate
Participate and present scientific data in meetings
Interact with collaborators for data and project demands
Maintain instruments and follow labs general equipment cleaning protocols
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an employee with these qualifications.
Basic Qualifications:
Bachelors degree in Analytical Chemistry, Physical, Life Sciences or related technical discipline
OrAssociates degree in Analytical Chemistry, Physical, Life Sciences or related technical discipline and 4 years of experience performing analytical testing
Or
High school diploma / GED and 6 years of experience performing analytical testing
Preferred Qualifications:
Excellent understanding of color, clarity, visual, pH, osmolality, density, concentration, solid state extraction, HIAC, Karl-Fisher techniques and strong hands-on technical skills to address challenging technical issues
Strong ability to analyze and interpret analytical results
Excellent organization and communication (oral and written) skills and attention to details
Ability to learn new technology quickly, multi-task and adapt in a dynamic environment
Possess a positive attitude and strong selfmotivation
Some of the vast rewards of working here
As we work to develop treatments that take care of others, we also 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 improve your potential along your career journey
A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.comJoin 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, Puerto Rico and Canada 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.Company
We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.
We live the mission.
We win together.
We thrive on continual challenge.
Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.
At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.
Connect with us to explore how you can Win, Live, and Thrive at Amgen.
- Website
- http://careers.amgen.com/
- Phone
- 805-447-1000
- Location
-
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States
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