Process Development Pivotal Drug Product Senior Associate

Amgen • Cambridge, MA

120d • $85,306 - $103,484 • Hybrid

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. 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.

Requirements

• High school diploma / GED and 6 years of Scientific, Engineering or Operations experience; OR Associate's degree and 4 years of Scientific, Engineering or Operations experience; Or Bachelor's degree and 2 years of Scientific, Engineering or Operations experience; Or Master's degree.

Nice To Haves

• Degree in Chemical Engineering, Biomedical Engineering, Biochemistry, Biotechnology, Pharmaceutics or related subject area.
• 2+ years of experience in pharmaceuticals/biotechnology that includes formulation development, scale up process development, and technology transfer.
• Knowledge of Drug Product unit operations (i.e. ultrafiltration/diafiltration, filling, filtration, mixing, etc.) and experience with relevant analytical techniques (i.e. SEC, CEX, HIAC, MFI).
• Ability to learn new techniques and instrumentation, perform multiple tasks simultaneously, keep accurate records, adhere to instructions, and follow company policies.
• Experience with programming (e.g. Python, R, MATLAB) and database languages (e.g.SQL), as well as data visualization tools (e.g. Tableau, Spotfire) is a plus.
• Ability to learn and rapidly adapt to new requirements in a fast paced environment.
• Critical thinking, problem solving and independent research skills.
• Good organizational skills with strong attention to detail.
• Excellent communication (oral and written).

Responsibilities

• Work closely with a team of engineers and scientists responsible for the technical aspects of Amgen's drug product commercialization and lifecycle management.
• Support late stage Drug Product formulation and fill/finish process development for large molecule modalities (e.g. monoclonal antibodies, Bispecific Tcell engagers (BiTEs) and fusion proteins).
• Participate in planning, designing, implementing, and documenting studies related to drug product formulation and process development of various biologics (antibody, BiTE, other proteins) by applying basic science/engineering skills and prior knowledge.
• Evaluate product quality and process performance through analytical testing (e.g. protein concentration, pH, U/HPLC, rCE, particle analysis, moisture content).
• Apply advanced digital tools to automate data structuring, analyze large and diverse datasets and build intuitive visualizations.
• Operate and maintain automated lab equipment in support of formulation and process scale up study and material generation.
• Author/review technical protocols and reports and perform data verification.
• Participate in team meetings by sharing study designs, results and technical challenges.

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, including remote and hybrid work arrangements, where possible.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree