Process Development Senior Associate (Attribute Sciences)
BioSpace, Holly Springs, NC, United States
Process Development Senior Associate (Attribute Sciences)
This role is part of Amgen’s Attribute Sciences (AS) department within the Process Development (PD) organization. The position involves laboratory-based evaluation of material attributes using various analytical techniques, focusing on analytical testing, support, and troubleshooting.
What You Will Do
Effectively deliver rapid and robust analytical testing to the site, process development team, and quality control.
Provide analysis support for small‑scale model transfer, method transfers, investigation support, and continuous improvements.
Work closely with functions including Drug Substance, Quality, and Manufacturing.
Understand and apply analytical methodologies to detect product quality attributes and process‑related impurities using techniques such as chromatography, capillary electrophoresis, and UV‑Vis spectroscopy.
Execute methods, author reports, and ensure safety and compliance for all activities.
Basic Qualifications
High school diploma / GED and 6 years of Process Development / Chemistry or related experience.
Associates degree and 4 years of Process Development / Chemistry or related experience.
Bachelor's degree and 2 years of Process Development / Chemistry or related experience.
Master's degree (any field).
Preferred Qualifications
Degree in Chemistry or related area.
Experience in pharmaceutical process development with analytical support, method execution, and investigational testing.
Strong experience in single or multiple analytical techniques (e.g., CE and chromatography).
Experience in method transfers, validation, troubleshooting, and complex investigations.
Familiarity with USP monographs and ICH/FDA guidelines for analytical method transfer and validation.
Knowledge of analytical method troubleshooting and analysis of product quality attributes related to biological processing.
Strong oral and written communication skills and ability to interact effectively with stakeholders.
Excellent technical writing skills and attention to detail.
Self‑starter and valuable teammate.
What You Can Expect Of Us Amgen offers competitive benefits and comprehensive Total Rewards Plans aligned with local industry standards. We support professional and personal growth through a collaborative culture and well‑being initiatives.
Amgen is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other protected characteristic. Reasonable accommodation will be provided for individuals with disabilities to participate in the application or interview process, perform essential job functions, and receive benefits.
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What You Will Do
Effectively deliver rapid and robust analytical testing to the site, process development team, and quality control.
Provide analysis support for small‑scale model transfer, method transfers, investigation support, and continuous improvements.
Work closely with functions including Drug Substance, Quality, and Manufacturing.
Understand and apply analytical methodologies to detect product quality attributes and process‑related impurities using techniques such as chromatography, capillary electrophoresis, and UV‑Vis spectroscopy.
Execute methods, author reports, and ensure safety and compliance for all activities.
Basic Qualifications
High school diploma / GED and 6 years of Process Development / Chemistry or related experience.
Associates degree and 4 years of Process Development / Chemistry or related experience.
Bachelor's degree and 2 years of Process Development / Chemistry or related experience.
Master's degree (any field).
Preferred Qualifications
Degree in Chemistry or related area.
Experience in pharmaceutical process development with analytical support, method execution, and investigational testing.
Strong experience in single or multiple analytical techniques (e.g., CE and chromatography).
Experience in method transfers, validation, troubleshooting, and complex investigations.
Familiarity with USP monographs and ICH/FDA guidelines for analytical method transfer and validation.
Knowledge of analytical method troubleshooting and analysis of product quality attributes related to biological processing.
Strong oral and written communication skills and ability to interact effectively with stakeholders.
Excellent technical writing skills and attention to detail.
Self‑starter and valuable teammate.
What You Can Expect Of Us Amgen offers competitive benefits and comprehensive Total Rewards Plans aligned with local industry standards. We support professional and personal growth through a collaborative culture and well‑being initiatives.
Amgen is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other protected characteristic. Reasonable accommodation will be provided for individuals with disabilities to participate in the application or interview process, perform essential job functions, and receive benefits.
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