Process Development Sr Associate
Process Development Sr Associate
US - California - Thousand Oaks APLICAR AHORAJoin Amgen’s Mission of Serving Patients
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. 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.
Process Development Sr Associate
What you will do
Let’s do this! Let’s change the world!
In this vital role you will be part of our Cleaning Characterization group, based in Amgen’s Thousand Oaks, CA.
This group is responsible for the development of cleaning process design supporting new product introduction in Amgen internal manufacturing network for both drug substance and drug product. The cleaning characterization group perform bench scale studies to enable introduction of new molecules manufacturing in Amgen Manufacturing network. The group supports investigation of deviations/non conformances, writes technical cleaning evaluation reports, and supports plant inspections, including Prior Approval Inspections (PAIs).
Job Responsibilities:
Design and perform planned laboratory experiments in assessment of new product cleaning with existing cleaning process.
Help develop new methods, apparatus and procedures for bench-scale cleaning characterization work.
Write technical reports, assessments, and procedures.
Use characterization data to develop key operating parameters (KOPs), testing requirements and acceptance criteria for new product launches in manufacturing.
Work with Quality, Engineering and Cleaning Validation leads to implement Cleaning process requirements at full scale.
Write technical reports based on the bench scale studies supporting individual manufacturing site Cleaning validation program.
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 a motivated, curious and collaborative team-player with these qualifications.
Basic Qualifications:
High school diploma / GED and 6 years of Scientific experience OR
Associate’s degree and 4 years of Scientific experience OR
Bachelor’s degree and 2 years of Scientific experience OR
Master’s degree
Preferred Qualifications:
Master’s or Bachelor’s degree in a scientific field with demonstrated ability in laboratory environment in life science industry.
Design and perform bench-scale experiments, and assessment of data/results.
Analytical methods: Total Organic Carbon (TOC), protein assays, gel electrophoresis, spectroscopic methods, Biological Binding Method (Bioassay, SPR or ELISA).
Characterization of cleaning process processes for biologicals.
Experience of writing technical reports based on laboratory studies.
Good knowledge of scientific principles, methodologies and practices.
Lab methods, including handling and dispensing chemicals, preparing buffers and operation of common lab equipment, such as pH and conductivity meters.
Strong interpersonal skills and ability to communicate with unique background teams.
Strong lab studies management(project management) skills to prioritize the lab studies based on changing priorities.
Good written and verbal communication skills.
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, including remote and hybrid work arrangements, where possible
Apply now and make a lasting impact with the Amgen team.
careers.amgen.com
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