Process Development Scientist
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 Scientist What you will do Let’s do this. Let’s change the world. In this vital role you will join the Drug Product Technologies (DPT) in Thousand Oaks, California, is seeking a Process Development Scientist to support early clinical development of oral drug products for synthetic molecules. This hands-on laboratory position will focus on formulation and process development for platform immediate-release (IR) tablets and enabling formulations, including amorphous solid dispersions (ASDs). Process characterization will support early clinical supply across these formulations. GMP manufacturing will focus primarily on enabling formulations, particularly ASDs, while also supporting platform IR tablets as needed.
Requirements
- Doctorate degree
- Master’s degree and 2 years of Scientific experience
- Bachelor’s degree and 4 years of Scientific experience
Nice To Haves
- Hands-on GMP manufacturing experience with amorphous solid dispersions (ASDs) produced by hot-melt extrusion (HME) and/or spray-dried dispersion (SDD), including development of manufacturing procedures.
- Hands-on GMP experience with roller compaction and tablet compression for immediate-release (IR) tablets.
- Experience identifying and troubleshooting issues during GMP processing.
- Academic or professional background in pharmaceutical sciences, materials science, bioengineering, or an engineering discipline.
- In-depth understanding of pharmaceutical material science and how material properties affect formulation development, process performance, and manufacturability for early clinical programs.
- Experience supporting FIH drug product development, including formulation and process development for immediate-release (IR) tablets.
- Experience working with contract research or manufacturing organizations.
- Experience preparing or contributing to regulatory documentation, such as IND CMC sections, and interacting with regulatory authorities.
- Strong communication and collaboration skills, including the ability to work across functions and resolve project-related issues.
- Experience with physiologically based biopharmaceutics modeling tools such as GastroPlus or Simcyp.
Responsibilities
- Develop and optimize oral drug product formulations and processes for early clinical studies, including platform IR tablets and enabling formulations.
- Conduct laboratory studies to characterize materials and formulations, assess process performance, and establish manufacturable approaches.
- Collaborate with colleagues across DPT and partner functions, including Drug Substance Technologies, Attribute Sciences, Regulatory Affairs, Supply Chain, Pharmacokinetics and Drug Metabolism, Clinical Pharmacology, and Biostatistics, as well as external manufacturing partners and academic groups.
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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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Ph.D. or professional degree
