BioSpace
Process Development Sr Associate
Join the Amgen team as a Process Development Sr Associate. The role is based in Amgen’s Thousand Oaks, CA location and focuses on cleaning characterization within the Manufacturing network.
What You Will Do
Design and perform planned laboratory experiments to assess new product cleaning with existing cleaning processes.
Help develop new methods, apparatus and procedures for bench‑scale cleaning characterization work.
Write technical reports, assessments and procedures.
Use characterization data to develop key operating parameters (KOPs), testing requirements and acceptance criteria for new product launches in manufacturing.
Work with Quality, Engineering and Cleaning Validation leads to implement cleaning process requirements at full scale.
Write technical reports based on bench‑scale studies to support individual manufacturing site cleaning validation programs.
Qualifications
Basic Qualifications:
High school diploma/GED and 6 years of scientific experience OR Associate’s degree and 4 years of scientific experience OR Bachelor’s degree and 2 years of scientific experience OR Master’s degree
Preferred Qualifications:
Master’s or Bachelor’s degree in a scientific field with demonstrated ability in laboratory environment in the life science industry. Design and perform bench‑scale experiments and assessment of data/results. Experience with analytical methods: TOC, protein assays, gel electrophoresis, spectroscopic methods, and biological binding methods (Bioassay, SPR or ELISA). Characterization of cleaning processes for biologicals. Experience writing technical reports based on laboratory studies. Good knowledge of scientific principles, methodologies and practices. Lab skills in handling chemicals, preparing buffers, and operating common lab equipment (pH, conductivity meters). Strong interpersonal skills and ability to communicate with cross‑functional teams. Project management skills to prioritize lab studies. Strong written and verbal communication skills.
Benefits
Competitive annual salary (range posted).
Health and welfare plans for staff and eligible dependents.
Retirement and savings plans with company contributions.
Discretionary annual bonus program and sales‑based incentive plans.
Stock‑based long‑term incentives.
Time‑off plans and flexible work models, including remote and hybrid arrangements where possible.
EEO Statement 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.
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What You Will Do
Design and perform planned laboratory experiments to assess new product cleaning with existing cleaning processes.
Help develop new methods, apparatus and procedures for bench‑scale cleaning characterization work.
Write technical reports, assessments and procedures.
Use characterization data to develop key operating parameters (KOPs), testing requirements and acceptance criteria for new product launches in manufacturing.
Work with Quality, Engineering and Cleaning Validation leads to implement cleaning process requirements at full scale.
Write technical reports based on bench‑scale studies to support individual manufacturing site cleaning validation programs.
Qualifications
Basic Qualifications:
High school diploma/GED and 6 years of scientific experience OR Associate’s degree and 4 years of scientific experience OR Bachelor’s degree and 2 years of scientific experience OR Master’s degree
Preferred Qualifications:
Master’s or Bachelor’s degree in a scientific field with demonstrated ability in laboratory environment in the life science industry. Design and perform bench‑scale experiments and assessment of data/results. Experience with analytical methods: TOC, protein assays, gel electrophoresis, spectroscopic methods, and biological binding methods (Bioassay, SPR or ELISA). Characterization of cleaning processes for biologicals. Experience writing technical reports based on laboratory studies. Good knowledge of scientific principles, methodologies and practices. Lab skills in handling chemicals, preparing buffers, and operating common lab equipment (pH, conductivity meters). Strong interpersonal skills and ability to communicate with cross‑functional teams. Project management skills to prioritize lab studies. Strong written and verbal communication skills.
Benefits
Competitive annual salary (range posted).
Health and welfare plans for staff and eligible dependents.
Retirement and savings plans with company contributions.
Discretionary annual bonus program and sales‑based incentive plans.
Stock‑based long‑term incentives.
Time‑off plans and flexible work models, including remote and hybrid arrangements where possible.
EEO Statement 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.
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