Process Development Sr Scientist

About the role

In this vital role you will design and execute experiments at the bench scale, spanning the end-to-end drug substance process, within cell culture and purification operations. The candidate will apply established platform approaches and utilize problem-solving skills to rapidly solve day-to-day experimental challenges. Additionally, the candidate will utilize out-of-the-box thinking to contribute to technology development. Finally, the candidate will also expand and develop skills within the cell-culture and purification functions, thereby further contributing to the integrated group.

Responsibilities

• Apply established platform approaches and problem-solving skills to rapidly tackle drug substance challenges and build robust processes with efficient experimentation
• Drive innovation and utilize out-of-the-box thinking to contribute to technology development
• Expand and develop skills in cell culture and purification, thereby further contributing to the integrated group
• Participate in drug substance teams and collaborate cross functionally with analytical and drug product representatives to deliver drug substance manufacturing processes in a phase-appropriate manner
• Deliver process amenable to cGMP operation and carry out results of drug substance in a cGMP manufacturing environment
• Author, or provide direction for the authorship of, technical report or CMC regulatory submissions which may require minimal additional editing

Requirements

• Doctorate degree (PhD or PharmD or MD) OR
• Master’s degree and 3 years of Scientific experience OR
• Bachelor’s degree and 5 years of Scientific experience

Qualifications

• Ability to identify, develop and implement solutions to practical problems through application of fundamental scientific and engineering principles, preferably in a process development environment
• Advanced understanding of cell culture and/or purification techniques such as aseptic techniques, bioreactor production, harvest operations, protein chromatography, TFF, filtration, etc.; hands-on experience with cell culture or purification operations needed
• Extensive experience in development and/or support of biomanufacturing processes, including process scale-up and GMP production
• Prior experience with data analytical tools (Excel, Spotfire, etc.) is preferred. Experience with statistical analysis and programming in JMP, R, and/or Python environments is a plus
• Motivated self-starter with excellent oral and written communication, interpersonal, and organizational skills
• Team player with the ability to successfully work within a diverse team in a dynamic, cross-functional environment
• Familiarity with design of experiments and statistical analysis of data is desirable
• Track record of innovation and implementation of new technologies
• Experience in authoring CMC regulatory documents in support of Amgen’s regulatory filings

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