BioSpace
Overview
Join to apply for the
Process Development Sr Associate
role at
BioSpace . 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 the fight against the world’s toughest diseases. We focus on Oncology, Inflammation, General Medicine, and Rare Disease, reaching millions of patients each year. The role is based in Amgen’s Thousand Oaks, CA, in the Cleaning Characterization group which supports cleaning process design for new product introductions in Amgen’s internal manufacturing network for both drug substance and drug product. Responsibilities
Design and perform planned laboratory experiments to assess new product cleaning with existing cleaning processes. Help develop new methods, apparatus, and procedures for bench-scale cleaning characterization work. Write technical reports, assessments, and procedures. Use characterization data to develop key operating parameters (KOPs), testing requirements, and acceptance criteria for new product launches in manufacturing. Collaborate with Quality, Engineering and Cleaning Validation leads to implement cleaning process requirements at full scale. Write technical reports based on bench-scale studies to support the individual manufacturing site Cleaning validation program. What We Expect Of You
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a motivated, curious, and collaborative team-player with these qualifications. Basic Qualifications
High school diploma / GED and 6 years of scientific experience OR Associate’s degree and 4 years of scientific experience OR Bachelor’s degree and 2 years of scientific experience OR Master’s degree Preferred Qualifications
Master’s or Bachelor’s degree in a scientific field with demonstrated ability in a laboratory environment in life science industry. Experience designing and performing bench-scale experiments and assessing data/results. Analytical methods: TOC, protein assays, gel electrophoresis, spectroscopic methods, Bioassay/SPR/ELISA. Characterization of cleaning process processes for biologicals. Experience writing technical reports based on laboratory studies. Strong knowledge of scientific principles, methodologies, and practices. Lab methods including handling and dispensing chemicals, preparing buffers, and operating common lab equipment (pH/conductivity meters). Strong interpersonal and communication skills; ability to work with diverse teams. Lab studies management and project management skills to prioritize studies based on changing priorities. What You Can Expect From Us
We support your professional and personal growth and well-being. Competitive benefits and a collaborative culture accompany a comprehensive rewards package, including health and welfare plans, retirement savings, time-off, flexible work models where possible. Apply now and make a lasting impact with the Amgen team. careers.amgen.com
#J-18808-Ljbffr
Join to apply for the
Process Development Sr Associate
role at
BioSpace . 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 the fight against the world’s toughest diseases. We focus on Oncology, Inflammation, General Medicine, and Rare Disease, reaching millions of patients each year. The role is based in Amgen’s Thousand Oaks, CA, in the Cleaning Characterization group which supports cleaning process design for new product introductions in Amgen’s internal manufacturing network for both drug substance and drug product. Responsibilities
Design and perform planned laboratory experiments to assess new product cleaning with existing cleaning processes. Help develop new methods, apparatus, and procedures for bench-scale cleaning characterization work. Write technical reports, assessments, and procedures. Use characterization data to develop key operating parameters (KOPs), testing requirements, and acceptance criteria for new product launches in manufacturing. Collaborate with Quality, Engineering and Cleaning Validation leads to implement cleaning process requirements at full scale. Write technical reports based on bench-scale studies to support the individual manufacturing site Cleaning validation program. What We Expect Of You
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a motivated, curious, and collaborative team-player with these qualifications. Basic Qualifications
High school diploma / GED and 6 years of scientific experience OR Associate’s degree and 4 years of scientific experience OR Bachelor’s degree and 2 years of scientific experience OR Master’s degree Preferred Qualifications
Master’s or Bachelor’s degree in a scientific field with demonstrated ability in a laboratory environment in life science industry. Experience designing and performing bench-scale experiments and assessing data/results. Analytical methods: TOC, protein assays, gel electrophoresis, spectroscopic methods, Bioassay/SPR/ELISA. Characterization of cleaning process processes for biologicals. Experience writing technical reports based on laboratory studies. Strong knowledge of scientific principles, methodologies, and practices. Lab methods including handling and dispensing chemicals, preparing buffers, and operating common lab equipment (pH/conductivity meters). Strong interpersonal and communication skills; ability to work with diverse teams. Lab studies management and project management skills to prioritize studies based on changing priorities. What You Can Expect From Us
We support your professional and personal growth and well-being. Competitive benefits and a collaborative culture accompany a comprehensive rewards package, including health and welfare plans, retirement savings, time-off, flexible work models where possible. Apply now and make a lasting impact with the Amgen team. careers.amgen.com
#J-18808-Ljbffr