Process Development Senior Scientist - Pivotal Biologics Drug Substance Technology

Amgen Inc.•Thousand Oaks, CA

28d

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. Process Development Senior Scientist - Pivotal Biologics Drug Substance Technology What you will do Let's do this. Let's change the world. In this vital role you will be responsible for development, characterization, scale-up and support of drug substance processes to enable commercial advancement of programs from Ph II/III clinical trials to marketing application. Work in a coordinated group in which cell culture and purification scientists work together to advance Amgen's rich, exciting and dynamic pipeline. With Amgen's biology first approach, the position provides the outstanding opportunity of being able to work on multiple modalities from antibodies and oncolytic viruses to bispecifics and antibody-drug conjugates. The Pivotal Drug Substance Process Development organization at Amgen develops, characterizes and supports the commercialization of biologics drug substance manufacturing processes for all late-stage programs across the Amgen portfolio. Apply established platform approaches and problem-solving skills to rapidly tackle drug substance challenges and build robust processes with efficient experimentation Drive innovation and apply 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 What we expect of you We are all different, yet we all use our unique contributions to serve patients. The collaborative professional we seek is a dynamic thought leader with these qualifications.

Requirements

Doctorate degree (Complete degree by 12/2025) OR
Master's degree and 3 years of life sciences experience OR
Bachelor's degree and 5 years of life sciences experience OR

Nice To Haves

Doctorate in Chemical Engineering, Biochemical Engineering, or other relevant sciences
Consistent track record of decision-making and trouble-shooting protein drug substance purification processes, preferably in a process development environment
Strong understanding and extensive hands-on experience in protein chromatography, including affinity, ion exchange, and hydrophobic interaction chromatography
Experience in filtration operations, including ultrafiltration/diafiltration
Understanding of protein characteristics and critical attributes to direct product/process control strategies
Proven ability to independently identify, develop and implement scientific solutions to practical problems.
Motivated self-starter with excellent interpersonal and organizational skills
Leadership experience of progressively increased scope and ability to encourage and lead a group of scientists
Eminence in the scientific community through a sustained record of peer reviewed publications
Demonstrated success working with diverse team members in a dynamic, cross-functional environment
Familiarity with design of experiments and statistical analysis of data
Knowledge of license applications and the drug development process
Exposure to cGMP manufacturing and CMC components of regulatory submissions

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 apply 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.

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