Process Development Senior Scientist - Pre-Pivotal Drug Product Technologies

BioSpace; Thousand Oaks (CA); Sur place; USD 125 000 - 165 000; Plein temps

Résumé du poste

Amgen is seeking a Process Development Sr Scientist in Thousand Oaks, CA to drive early-stage drug product development across modalities, with a strong emphasis on monoclonal antibodies and other biologics.

You will design and develop liquid and lyophilized formulations, establish robust fill/finish processes, and collaborate across process development, research, regulatory, and manufacturing to advance programs and support regulatory submissions.

Responsabilités

• Join Pre-Pivotal Drug Product Technologies group, focused on early-stage drug product development across modalities, with emphasis on monoclonal antibodies and other biologics.
• Design and develop liquid and lyophilized formulations and establish robust fill/finish processes.
• Collaborate across process development, research, regulatory, and manufacturing to advance programs and support regulatory submissions.

Description du poste

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll 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

• Lets do this. Lets change the world. In this vital role you will join Pre-Pivotal Drug Product Technologies group, responsible for early-stage drug product development across diverse modalities, with a strong emphasis on monoclonal antibodies,multispecificsandotherbiologicmodalities. The role involves designing and developing liquid and lyophilized formulations; evaluating critical quality attributes (CQAs);establishingrobust, scalable fill/finish processes for complex biologic drug products; and authoringand supportinghigh quality regulatory submissions.
• Work effectively in a fast-paced, matrixed environment, collaborating across process development, research, regulatory, and manufacturing teams to advance programs and communicate technical recommendations to both scientific peers and leadership.
• Plan and execute formulation and fill/finish