Process Development – Pre-Pivotal Biologics Attribute Sciences Associate

Amgen; Thousand Oaks (CA); Presencial; USD 75.000 - 101.000; Jornada completa

Descripción de la vacante

Amgen Inc. (IR) in Thousand Oaks, CA is seeking a Process Development – Pre-Pivotal Biologics Attribute Sciences Associate to support analytical development and product characterization for novel biotherapeutics.

You will collaborate with ASTLs and cross-functional partners to advance programs toward the clinic. The role involves laboratory studies, method development, data interpretation, and contributing to regulatory documentation, with exposure to diverse biologic modalities and digital data

Formación

• Bachelor's degree OR Associate's degree plus 2 years of scientific experience OR High school diploma/GED plus 4 years of scientific experience.
• 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.

Responsabilidades

• Perform analytical testing and characterization studies to evaluate product quality attributes and stability characteristics of biotherapeutics; take increasing ownership of study design and execution.
• Co-verify and qualify analytical methods to enable GMP lab execution and support method establishment and validation activities at external sites.
• 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 in collaboration with ASTLs to support program needs.

Conocimientos

Analytical thinking

Problem solving

Written communication

Verbal communication

Collaboration

Educación

Bachelor's degree

Associate's degree

High school diploma / GED

Biochemistry/Biophysics/Analytical Chemistry/Bioprocess related degree

Descripción del empleo

Career Category Operations 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 – 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).

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

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

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.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

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 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.

We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.

We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Salary Range 74,503.35USD -100,798.65 USD

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen