Process Development Associate Scientist- Biological and Structural Characterization

About the role

Join Amgens 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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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 lie within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Responsibilities

• Develop, qualify and transfer state-of-the-art and fit-for-purpose quantitative potency and biological characterization assays and supporting sample testing and regulatory submissions.
• Implement state-of-the-art and fit-for-purpose analytical potency methods for: release testing, stability testing, product characterization/optimization, reference standard characterization, and investigations.
• Assist in the preparation of technical reports for investigations, product and impurity characterization, and regulatory submissions.
• Generate and analyze analytical data to support: product development and regulatory submissions.
• Contribute to critical analytical development teams (e.g., product and process development teams, product quality teams) by providing analytical updates, analytical documentation, and data interpretation.
• Keep current in analytical development field including literature and technology development.
• Support analytical projects involving method development, qualification, and transfer.

Requirements

• Masters degree and 1 year of scientific experience OR Bachelors degree and 3 years of scientific experience.
• Expertise in cell culture, and cell biology techniques for quantitative determination of biological activity of proteins.
• Expertise in cell-based bioassay development (characterization methods, qualification, validation, technical transfer).
• Expertise with signal transduction, gene expression, receptor binding and fluorescent probe technologies.
• Experience in molecular biology techniques to manipulate plasmid constructs for generation of transfected stable cell lines.
• Innovation supports new ideas and initiatives.
• Detail oriented and excellent documentation skills.
• Communication and interpersonal skills communicate effectively with others, using appropriate diplomacy and sensitivity; makes others feel respected, valued, and understood; works well in teams.

Qualifications

• Expertise in cell culture, and cell biology techniques for quantitative determination of biological activity of proteins.
• Expertise in cell-based bioassay development (characterization methods, qualification, validation, technical transfer).
• Expertise with signal transduction, gene expression, receptor binding and fluorescent probe technologies.
• Experience in molecular biology techniques to manipulate plasmid constructs for generation of transfected stable cell lines.
• Innovation supports new ideas and initiatives.
• Detail oriented and excellent documentation skills.
• Communication and interpersonal skills communicate effectively with others, using appropriate diplomacy and sensitivity; makes others feel respected, valued, and understood; works well in teams.

Skills

• Expertise in cell culture, and cell biology techniques for quantitative determination of biological activity of proteins.
• Expertise in cell-based bioassay development (characterization methods, qualification, validation, technical transfer).
• Expertise with signal transduction, gene expression, receptor binding and fluorescent probe technologies.
• Experience in molecular biology techniques to manipulate plasmid constructs for generation of transfected stable cell lines.
• Innovation supports new ideas and initiatives.
• Detail oriented and excellent documentation skills.
• Communication and interpersonal skills communicate effectively with others, using appropriate diplomacy and sensitivity; makes others feel respected, valued, and understood; works well in teams.

Benefits

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.

Pay

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.

Schedule

Actual schedule will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.