Process Development Associate

Career Category

Scientific

Job Description

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. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. 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 Associate

What you will do

Let’s do this. Let’s change the world. In this vital role you will support the development of manufacturing processes by conducting experiments, analyzing data, and documenting results. They work closely with senior scientists and engineers to implement process improvements.

Responsibilities include:

• Developing and implementing pioneering and fit-for-purpose analytical methods for: impurity release testing.
• Performing analytical testing to evaluate residual process impurities in drug substance and drug substance intermediates
• Preparing technical reports for investigations, product and impurity characterization, and regulatory submissions.
• Documenting laboratory activities according to GMP guidelines
• Generating, analyzing, and interpreting analytical data to support: product development investigations, routine testing, and regulatory submissions
• Keeps current in analytical development field including literature and technology development for groundbreaking and regulatory activities
• Supporting analytical projects involving method development, qualification, and transfer
• Participates in and contributes to critical analytical development teams (e.g., Product and process development teams, Product quality teams) by providing analytical updates and documentation.

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
OR
Associate’s degree and 2 years of Scientific experience
OR
High school diploma / GED and 4 years of Scientific] experience

Preferred Qualifications:

· Experience and expertise with protein assays, particularly ELISA as well as most common formats for measuring protein-protein interactions.

· Experience and expertise with molecular biology, particularly qPCR and DNA isolation.

· Experience with GDP documentation and Electronic Laboratory Notebook systems.

· Experience working in a GMP regulated environment, as well as with regulatory filings (IND, BLA, and NDA) and ICH Guidelines.

· Experience and expertise with Microsoft Office software, particularly Word, PowerPoint and Excel.

· Experience with data analysis and data analysis software, including JMP, R, SAS, and/or GraphPad.

· Innovation – positive approach to challenges; champions new insights and initiatives; brings out and applies others’ creativity to improve unit performance

· Communication – establishes and maintains effective communication mechanisms to keep staff appropriately advised; bridges communication between individuals, units and other organizations as necessary

• Social skills – communicates optimally, using appropriate tact and sensitivity; makes others feel respected, valued and understood

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

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