Join 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 Senior Associate - Cellular Sciences - Biosafety Development Group
What you will do
Let’s do this! Let’s change the world!
In this vital role you will join our Biosafety Development (BSD) group.
The Senior Associate will support ensuring patient safety by performing sterile filtration validation studies for Amgen’s pharmaceutical products. Also, they may partake in technology development for detection and identification of bacterial adventitious agents.
Primary focus will be on performing GMP validation studies for sterile filtration via Standard Operating Procedures and qualified detection methods using model bacterial strains. These studies will support IND and MA filings to the FDA. Test articles are generated with protein purification processes and will require preliminary testing to assess matrix interference with bacterial health. Assays performed for the detection of bacteria may include traditional detection methods and/or molecular techniques.
Responsibilities may include the following:
Leading and executing GMP bacterial filtration retention studies to support IND and MA filings to the FDA.
Utilizing traditional or molecular assays for the detection of bacterial adventitious agents.
Applying filtration knowledge and techniques to troubleshoot problems during execution of studies.
Assay method development and qualification.
Training other employees.
Managing materials and supply inventory.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is a collaborative partner 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:
Hands on experience with purification processes, especially filtration. Previous work assessing and validating filtration loading and performance using small-scale model devices is desired.
Hands on experience with bacterial detection techniques, including molecular biology methods (e.g., qPCR); method development experience a plus.
Possess strong written and verbal communication skills and a desire to learn new scientific concepts.
Work as a member of a small team to follow and develop methods.
Demonstrate good planning and project execution skills.
Clearly and concisely interpret and present data.
Ability to understand, apply and evaluate biological and mathematical principles.
Excellent sterile technique.
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 where possible. Refer to the Work Location Type in the job posting to see if this applies.
Apply now and make a lasting impact with the Amgen team.
careers.amgen.com
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Sponsorship
Sponsorship for this role is not guaranteed.
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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
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, disability status, or any other basis protected by applicable law.
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.
.Salary Range
86,613.00 USD - 104,742.00 USD