Amgen Associate Manufacturing in Thousand Oaks, California
The Manufacturing Associate position will execute production unit operations and other activities supporting clinical and commercial operations for drug substance manufacturing in stainless steel and single-use equipment. The Manufacturing Associate will monitor critical processes, execute routine validation protocols, and prepare documents such as Batch Records, SOPs and technical reports. They will perform basic troubleshooting and assist in the review of documentation for assigned functions. The Associate Manufacturing may participate on cross-functional teams, have the responsibility of owning NC/CAPAs, and may identify, recommend, and implement improvements related to routine functions. This role will interface between the GMP manufacturing teams in the plant and Quality, Engineering, and other partner organizations.
JOB SCOPE AND RESPONSIBILITIES:
Under minimal supervision, performs manufacturing processes according to Standard Operating Procedures.
Set-up, clean, and sanitize equipment, and prepare media and buffers per procedures
LEAD, PERFORM, AND MONITOR CRITICAL PROCESSES
Align with cGMP's
Analytical testing to support production, including pH, cell counting, protein concentration, etc.
Identify and recommend improvements to operations, and implement after approval
Recognize & accurately report problems
Assist in the review of documentation for assigned functions (e.g. equipment logs, routine area audits, batch records)
Train new staff to perform hands-on tasks
May act as safety representative
Ability to be flexible and handle change
Associate's degree and 4 years of biotech or pharmaceutical manufacturing, process development or quality experience
High School diploma/GED and 6 years of biotech or pharmaceutical manufacturing, process development or quality experience
1+ years of experience in regulated environment
Experience and basic troubleshooting skills with laboratory and process equipment
Experience with DeltaV, OSI PI, LIMS, TRACKWISE
Understand, apply and evaluate basic chemistry, biology and physical principles
Adhere to regulatory requirements, written procedures, and safety guidelines
Evaluate documentation/data according to company and regulatory guidelines
Interact with inspectors (internal and external)
Interpret and apply current Good Manufacturing Practices (cGMP)
Ability to demonstrate written and oral communication skills
Technical writing capabilities
Available for non-standard shifts including nights and weekends.
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.