Process Development Sr Associate - Attribute Sciences

Amgen • Holly Springs, NC

20h • $80,045 - $108,296

About The Position

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re 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’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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 lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. PROCESS DEVELOPMENT SR ASSOCIATE - ATTRIBUTE SCIENCES What you will do Let’s do this. Let’s change the world. In this vital role you will be 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 work to provide scientific and technical contributions within Process Development Attribute Sciences at Amgen’s FleX Batch facility. This laboratory-based role will evaluate attributes of materials based upon multiple analytical techniques, focusing on analytical testing, support, and troubleshooting. Responsibilities include effectively delivering to the site, process development team, manufacturing and quality control through rapid and robust analytical testing. Ensure analytical 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 testing using a variety of techniques including but not limited to ELISA, qPCR and UV-Vis spectrophotometry. Execute methods, author reports and ensure safety and compliance for all activities.

Requirements

• 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

Nice To Haves

• Degree in Analytical Chemistry, Biochemistry, or related area.
• Experience in pharmaceutical process development with related experience in analytical support, execution of methods, and investigational testing.
• Strong experience in a variety of analytical techniques (i.e., ELISA, qPCR, SoloVPE).
• Experience in method transfers, method validation, method troubleshooting, and complex investigations.
• Solid understanding of GMP requirements and familiarity with USP monographs and chapters, as well 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 details and compliance with GDP.
• Proven ability to work effectively in collaborative, team-based settings.

Responsibilities

• Provide scientific and technical contributions within Process Development Attribute Sciences at Amgen’s FleX Batch facility.
• Evaluate attributes of materials based upon multiple analytical techniques, focusing on analytical testing, support, and troubleshooting.
• Effectively deliver to the site, process development team, manufacturing and quality control through rapid and robust analytical testing.
• Ensure analytical 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 testing using a variety of techniques including but not limited to ELISA, qPCR and UV-Vis spectrophotometry.
• Execute methods, author reports and ensure safety and compliance for all activities.

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior