Process Development Sr Associate - Attribute Sciences
Amgen
4 hours ago
On-site
Holly Springs, NC
Operations
PROCESS DEVELOPMENT SR ASSOCIATE - ATTRIBUTE SCIENCES
What You Will Do
- Provide scientific and technical contributions in Process Development Attribute Sciences at Amgen’s FleX Batch facility.
- Evaluate attributes of materials using multiple analytical techniques, focused on analytical testing, support, and troubleshooting.
- Deliver rapid and robust analytical testing to the site, process development team, manufacturing, and quality control.
- Ensure analytical support for small-scale model transfer, method transfers, investigation support, and continuous improvements.
- Work closely with Drug Substance, Quality, and Manufacturing.
- Use analytical methodologies to detect product quality attributes and process-related impurities testing (e.g., ELISA, qPCR, UV-Vis spectrophotometry).
- Execute methods, author reports, and ensure safety and compliance.
Basic Qualifications
- High school diploma/GED and 6 years related experience OR
- Associate’s degree and 4 years related experience OR
- Bachelor’s degree and 2 years related experience OR
- Master’s degree.
Preferred Qualifications
- Degree in Analytical Chemistry, Biochemistry, or related area.
- Pharmaceutical process development experience with analytical support, method execution, and investigational testing.
- Strong experience with ELISA, qPCR, SoloVPE.
- Experience in method transfers, validation, troubleshooting, and complex investigations.
- GMP understanding; familiarity with USP monographs/chapters and ICH guidance.
- Knowledge of analytical troubleshooting and product quality attributes in biological processing.
- Strong communication, technical writing, attention to detail, GDP compliance, and teamwork.
Total Rewards Plan (eligibility-based)
- Health and welfare plans, retirement/savings plan, financial plans, work/life balance, career development, bonus/incentives, stock-based long-term incentives, time-off plans, and flexible work models where possible.
Application Instructions
- Apply now at careers.amgen.com. No application deadline; accepted until sufficient applications or a candidate is selected.
What You Will Do
- Provide scientific and technical contributions in Process Development Attribute Sciences at Amgen’s FleX Batch facility.
- Evaluate attributes of materials using multiple analytical techniques, focused on analytical testing, support, and troubleshooting.
- Deliver rapid and robust analytical testing to the site, process development team, manufacturing, and quality control.
- Ensure analytical support for small-scale model transfer, method transfers, investigation support, and continuous improvements.
- Work closely with Drug Substance, Quality, and Manufacturing.
- Use analytical methodologies to detect product quality attributes and process-related impurities testing (e.g., ELISA, qPCR, UV-Vis spectrophotometry).
- Execute methods, author reports, and ensure safety and compliance.
Basic Qualifications
- High school diploma/GED and 6 years related experience OR
- Associate’s degree and 4 years related experience OR
- Bachelor’s degree and 2 years related experience OR
- Master’s degree.
Preferred Qualifications
- Degree in Analytical Chemistry, Biochemistry, or related area.
- Pharmaceutical process development experience with analytical support, method execution, and investigational testing.
- Strong experience with ELISA, qPCR, SoloVPE.
- Experience in method transfers, validation, troubleshooting, and complex investigations.
- GMP understanding; familiarity with USP monographs/chapters and ICH guidance.
- Knowledge of analytical troubleshooting and product quality attributes in biological processing.
- Strong communication, technical writing, attention to detail, GDP compliance, and teamwork.
Total Rewards Plan (eligibility-based)
- Health and welfare plans, retirement/savings plan, financial plans, work/life balance, career development, bonus/incentives, stock-based long-term incentives, time-off plans, and flexible work models where possible.
Application Instructions
- Apply now at careers.amgen.com. No application deadline; accepted until sufficient applications or a candidate is selected.