Process Development – Pre-Pivotal Biologics Attribute Sciences Associate

Process Development – Pre-Pivotal Biologics Attribute Sciences Associate

What you will do

Let’s do this. Let’s change the world. In this vital role you will work closely with Attribute Sciences Team Leads (ASTLs) and cross-functional partners to support analytical development and product characterization for novel biotherapeutics. You will perform laboratory studies to characterize product quality attributes, develop and execute analytical methods, interpret and document experimental results, and support testing of development materials. You will contribute to understanding the stability, quality, and developability of candidate molecules and help establish the analytical foundation needed to advance programs toward the clinic. This position offers the opportunity to work across a diverse portfolio of biologic modalities and collaborate with scientists across Research and Process Development while building broad experience in biopharmaceutical analytical development. The position is located at our Thousand Oaks, CA site.

• Perform analytical testing and characterization studies to evaluate product quality attributes and stability characteristics of biotherapeutics, with opportunities to take increasing ownership of study design and execution

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• Co-verify and qualify analytical methods to enable GMP lab execution and support method establishment and validation activities at external sites through review of methods and validation protocols

• Support testing of drug substance, drug product, and other development materials to enable formulation, process development, stability, and product characterization studies

• Conduct product characterization studies using fraction collection, enzymatic digestions, and forced degradation to interrogate critical quality attributes

• Analyze, verify, interpret, and document experimental data, working closely with Attribute Sciences Team Leads (ASTLs) to support program needs and developing increasing independence in data interpretation and scientific problem solving

• Support preparation of technical reports, regulatory documentation, and scientific presentations through data compilation, verification, and analysis

• Evaluate and implement new analytical technologies to enhance product and attribute understanding

• Contribute to the development and implementation of digital capabilities, including automation of analytical data processing, visualization, and data management workflows

• Collaborate with cross-functional partners in Research, Process Development, Manufacturing, and external organizations to support advancement of pre-pivotal programs

• Steward analytical deliverables with accuracy, compliance, and adherence to Good Documentation Practices (GDP).

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 leader 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:

• Scientific or bioengineering background with experience or demonstrated interest in the development and characterization of proteins, biologics, or hybrid therapeutic modalities
• Degree in Biochemistry, Biophysics, Analytical Chemistry, Protein Chemistry, Bioengineering, Biotechnology, Pharmaceutical Sciences or related subject areas
• Strong analytical thinking, problem-solving, and troubleshooting skills.
• Experience with or aptitude in applying digital tools for data analysis and automation to improve analytical workflows and data processing
• Strong written and verbal communication skills with the ability to organize, prioritize, and reliably execute multiple activities in a collaborative environment
• Attention to detail, compliance with GDP, and ability to adapt to dynamic priorities.
• Self-motivated, curious, innovative, and collaborative mindset, with a desire to learn, solve scientific problems, and develop increasing technical and scientific independence

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

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Apply now and make a lasting impact with the Amgen team.

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