Process Development Associate

About the role

In this vital role you will contribute towards Amgen’s Drug Substance Process Development for late stage clinical and commercial biologics programs, including the development, characterization, and scale-up of upstream and downstream manufacturing processes supporting Ph II/III clinical trials to marketing application. This role is within an integrated organization in which cell culture and purification scientists work together to advance Amgen's rich and dynamic pipeline. With Amgen's biology first approach, the position provides a unique opportunity to work on multiple modalities, from antibodies to oncolytic viruses to bi-specifics.

The Process Development Associate will help design and perform experiments at the bench scale that span the end-to-end Drug Substance process, from cell culture to purification operations. You will apply established platform approaches and utilize problem-solving skills to rapidly solve day-to-day experimental challenges. Additionally, you will utilize out-of-the-box thinking to contribute to technology development and demonstrate the desire to expand and develop expertise in both cell culture and purification, thereby further contributing to the integrated group. The Process Development Associate will join a diverse team with varied levels of experience and report to a Process Development Principal Scientist.

Responsibilities

• Contribute within a project team on goals such as improving process yield and robustness, and scaling-up processes to manufacturing sites
• Perform small-scale bioprocess experiments that encompass both upstream (cell culture) and downstream (purification) operations
• Cell culture responsibilities may include maintaining cultures in shake flasks, culture bags, and benchtop bioreactors
• Purification experiments include, but are not limited to, protein chromatography, filtration, and UF/DF operations
• Automation programming for benchtop bioreactors, chromatography systems, and robotic liquid handling systems
• Experimental design and data interpretation, leveraging in-house visualization and analytics tools
• Communication of findings through oral presentations and written documentation (technical reports as well as GMP documents to support regulatory filings)
• Provide scientific technical support for technology transfer of processes to manufacturing sites

Requirements

Basic Qualifications

• Bachelor’s Degree
• Associate’s degree and 2 years of Scientific experience
• High school diploma/GED and 4 years of Scientific experience

Preferred Qualifications

• Bachelor's degree in Chemical, Biomedical, or related Engineering; Life Sciences; or other relevant sciences
• Experience and demonstrated interest in laboratory work, particularly hands-on experience with mammalian cell culture and/or purification operations
• Basic understanding of cell culture, protein chromatography, and filtration principles
• Demonstrated ability to identify and solve problems by applying scientific and engineering principles, preferably in a process development environment
• Strong communication and interpersonal skills, and the ability to work flexibly in a dynamic and collaborative environment with diverse team members
• Familiarity with design of experiments and statistical analysis of data

Benefits

From our competitive benefits to our collaborative culture, we 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.

• 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