Process Development Scientist
Process Development Scientist
US - California - Thousand Oaks Apply NowJoin 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 Scientist
What you will do
Let’s do this! Let’s change the world!
Amgen's Commercial Attribute Sciences group within Process Development is seeking a Scientist/Sr. Scientist. The successful candidate will be responsible for supporting implementation of new analytical technology, tech transfer/method transfer, method remediation and investigations for commercial programs. The successful candidate will also serve as an analytical subject matter expert responsible for supporting investigations and troubleshooting of method-related testing challenges across analytical platforms. The role will involve close partnership with Attribute Sciences Team Leads (ASTLs), network analytical experts, local and global Quality Control partners, and other cross-functional colleagues including from Drug Substance Technologies, Drug Product Technologies, Product Quality, Regulatory CMC, and Supply Chain.
Key Responsibilities:
Generate, analyze, and critically evaluate analytical data to drive product advancement, support investigations, regulatory submissions and ensure commercial supply
Support process and method lifecycle management, including testing to support method remediation, qualification and transfer as well as process improvements and new product introduction
Interact and collaborate with other functional areas in matrix environment as an analytical subject matter expert
Author and review technical reports and sections of regulatory filings.
May participate or contribute to analytical development teams (e.g., Product delivery teams, Product quality teams) by providing analytical updates, analytical documentation and data interpretation
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 individual with these qualifications.
Basic Qualifications:
Bachelor’s degree and 4 years of Scientific experience OR
Master’s degree and 2 years of Scientific experience OR
Doctorate degree
Preferred Qualifications:
Strong understanding of protein therapeutics analytical life cycle development, protein product quality attributes and analytical control strategy
Extensive experience in a wide variety of analytical techniques such as CEX, SEC, Reverse Phase Chromatography, HILIC, CE, Compendial methods (e.g. pH, Osmolality etc.), Bioassays and Immunoassays
Ability to support investigations in an Analytical Subject Matter Expert (SME) capacity
Strong communication skills and ability to effectively communicate with cross-functional leadership and colleagues across the globe
Solid understanding of GMP requirements and familiarity with USP monographs and chapters, as well ICH guidance documents related to analytical method transfer and validation
Excellent technical writing skills and attention to detail in authoring technical reports and regulatory filing documents
A self-starter and team player with strong decision-making skills
Ability to multitask, clearly plan and effectively follow through on complex deliverables
What you can expect from 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
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
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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. 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 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.
