Process Development Sr Scientist

Amgen • Thousand Oaks, CA

5d • $126,066 - $170,560

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 Scientist
What you will do
Let’s do this. Let’s change the world. 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

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

Nice To Haves

• 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.

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.

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
• Education Level: Ph.D. or professional degree