Career CategoryScientific
Job DescriptionPROCESS DEVELOPMENT SR ASSOCIATE - ATTRIBUTE SCIENCESWhat you will doLet'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.
What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The collaborative professional we seek is a motivated, self-starter with these 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 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.
What you can expect of usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
- 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. Refer to the Work Location Type in the job posting to see if this applies.
Salary Range80,044.50USD -108,295.50 USD
