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Process Development Sr Associate - Holly Springs, NC

$80.04k - $108.3k

VetJobs

Job Description We are sourcing qualified talent for Amgen's Attribute Sciences (AS) department within Process Development. This laboratory-based role will evaluate attributes of materials based upon multiple analytical techniques, focusing on analytical testing, support, and troubleshooting. This role is on-Site at the location detailed in the job post. ATTENTION MILITARY AFFILIATED JOB SEEKERS: This position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. Responsibilities Effectively deliver to the site, process development team, manufacturing and quality control through rapid and robust analytical testing. Provide analytical support for small-scale model transfer, method transfers, investigation support, and continuous improvements. Work closely with functions including Drug Substance, Quality, and Manufacturing. Understand analytical methodologies to detect product quality attributes and process-related impurities testing using ELISA, qPCR, and UV-Vis spectrophotometry. Execute methods, author reports, and ensure safety and compliance for all activities. Qualifications Basic Qualifications: High school diploma / GED and 6 years of related experience OR Associate's degree and 4 years of related experience OR Bachelor's degree and 2 years of related experience OR Master's degree. Preferred Qualifications: Degree in Analytical Chemistry, Biochemistry, or related area. Experience in pharmaceutical process development with analytical support, execution of methods, and investigational testing. Strong experience in a variety of analytical techniques (ELISA, qPCR, SoloVPE). Experience in method transfers, method validation, method troubleshooting, and complex investigations. Solid understanding of GMP requirements, familiarity with USP monographs, chapters, and ICH guidance documents related to analytical method transfer and validation. Knowledgeable in analytical method troubleshooting and analysis of product quality attributes related to biological processing. Strong communication skills and ability to interact effectively with diverse internal and cross-functional teams. Excellent technical writing skills, attention to detail, and compliance with GDP. Proven ability to work effectively in collaborative, team-based settings. Benefits Amgen offers a total rewards plan including health and welfare plans, financial plans, work/life balance, and career development opportunities. The base salary range for this role is $80,044.50-108,295.50 USD (subject to factors such as experience, qualification, and location). Additional benefits include a comprehensive employee benefits package, a discretionary annual bonus program, stock-based long-term incentives, award-winning time-off plans, and flexible work models where applicable. Location City: Holly Springs; State: North Carolina. #J-18808-Ljbffr VetJobs

Vacancy posted 1 day ago
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