Process Development Senior Associate (Attribute Sciences)
BioSpace, Holly Springs, NC, United States
Join Amgen’s mission of serving patients. At Amgen, if you feel like you are 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 have helped pioneer the world of biotech in the fight against the world’s toughest diseases. With our focus on the four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease, we reach millions of patients each year. 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.
Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single‑use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will feature best‑in‑class drug substance manufacturing technologies with embedded industry 4.0 capabilities, and it will integrate sustainability innovations to reduce carbon and waste as part of Amgen's plan to be a carbon‑neutral company by 2027.
Process Development Senior Associate (Attribute Sciences) What You Will Do This role is part of Amgen’s Attribute Sciences (AS) department within the Process Development (PD) organization that defines the favorable quality characteristics of the therapies it produces and optimizes innovative analytical tools to guide that development. In this vital role, you will provide scientific and technical contributions within Process Development Attribute Sciences at Amgen’s FleX Batch facility. This laboratory‑based role evaluates attributes of materials using multiple analytical techniques, focusing on analytical testing, support, and troubleshooting.
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 but not limited to Drug Substance, Quality, and Manufacturing.
Understand analytical methodologies to detect product quality attributes and process‑related impurities using a variety of techniques including 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.
Associate’s 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.
Preferred Qualifications
Degree in Chemistry or related area.
Experience in pharmaceutical process development with analytical support, execution of methods, and investigational testing.
Strong experience in single or multiple analytical techniques (e.g., CE and Chromatography).
Experience in method transfers, method validation, method troubleshooting, and complex investigations.
Familiarity with and understanding of United States Pharmacopeia (USP) monographs and chapters, and International Conference on Harmonization (ICH) / FDA mentorship documents related to analytical method transfer and validation.
Knowledgeable in analytical method troubleshooting and analysis of product quality attributes related to biological processing.
Oral and verbal communication skills, effective interaction with diverse internal and external stakeholders.
Excellent technical writing skills and attention to detail in documents.
A self‑starter and valuable teammate.
What You Can Expect Of Us We work to develop treatments that take care of others while also caring for your professional and personal growth and well‑being. From competitive benefits to our collaborative culture, we support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans aligned with local industry standards.
Apply now and make a lasting impact with the Amgen team.
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.
#J-18808-Ljbffr
Since 1980, we have helped pioneer the world of biotech in the fight against the world’s toughest diseases. With our focus on the four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease, we reach millions of patients each year. 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.
Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single‑use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will feature best‑in‑class drug substance manufacturing technologies with embedded industry 4.0 capabilities, and it will integrate sustainability innovations to reduce carbon and waste as part of Amgen's plan to be a carbon‑neutral company by 2027.
Process Development Senior Associate (Attribute Sciences) What You Will Do This role is part of Amgen’s Attribute Sciences (AS) department within the Process Development (PD) organization that defines the favorable quality characteristics of the therapies it produces and optimizes innovative analytical tools to guide that development. In this vital role, you will provide scientific and technical contributions within Process Development Attribute Sciences at Amgen’s FleX Batch facility. This laboratory‑based role evaluates attributes of materials using multiple analytical techniques, focusing on analytical testing, support, and troubleshooting.
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 but not limited to Drug Substance, Quality, and Manufacturing.
Understand analytical methodologies to detect product quality attributes and process‑related impurities using a variety of techniques including 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.
Associate’s 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.
Preferred Qualifications
Degree in Chemistry or related area.
Experience in pharmaceutical process development with analytical support, execution of methods, and investigational testing.
Strong experience in single or multiple analytical techniques (e.g., CE and Chromatography).
Experience in method transfers, method validation, method troubleshooting, and complex investigations.
Familiarity with and understanding of United States Pharmacopeia (USP) monographs and chapters, and International Conference on Harmonization (ICH) / FDA mentorship documents related to analytical method transfer and validation.
Knowledgeable in analytical method troubleshooting and analysis of product quality attributes related to biological processing.
Oral and verbal communication skills, effective interaction with diverse internal and external stakeholders.
Excellent technical writing skills and attention to detail in documents.
A self‑starter and valuable teammate.
What You Can Expect Of Us We work to develop treatments that take care of others while also caring for your professional and personal growth and well‑being. From competitive benefits to our collaborative culture, we support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans aligned with local industry standards.
Apply now and make a lasting impact with the Amgen team.
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.
#J-18808-Ljbffr