Amgen

Associate Manufacturing

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Apr 20, 2019
Ref
R-74809
Required Education
Bachelors Degree
Position Type
Full time
This Cell Culture Manufacturing Associate position will support the on going commercial operations for drug substance intermediate and the start-up of new clinical and commercial drug substance manufacturing operation in Thousand Oaks, CA. The Associate will execute production operations on the manufacturing floor including execution and coordination of commissioning and qualification of process equipment. This role will interface between the GMP manufacturing teams in the plant and our partner organizations.

Job scope and responsibilities:

Under minimal supervision, performs manufacturing processes according to Standard Operating Procedures.

Duties to include:
  • Hands-on operations, set-up, clean, sanitize and prepare media and buffers per procedures
  • Lead, Perform, and monitor critical processes
  • Comply with GMP's
  • Regularly draft and revise "routine" documents (e.g. MPs, SOP's, and technical reports)
  • Initiate and Close Minor Deviations
  • Identify and recommend improvements related to routine functions and implement after approval
  • Basic troubleshooting
  • Recognize & accurately report problems
  • Direct operators on critical processes
  • Assist in the review of documentation for assigned functions (e.g. equipment logs, routine area audits, batch records)
  • May train staff to perform hands-on tasks
  • May act as safety representative
  • Ability to be flexible and manage change


Basic Qualifications:

Bachelor's degree

Or

Associate's degree and 4 years of biotech or pharmaceutical manufacturing, process development or quality experience

Or

High School diploma/GED and 6 years of biotech or pharmaceutical manufacturing, process development or quality experience

Preferred Qualifications:
  • Automation experience is highly desirable
  • Experience in Single Use Bioprocessing Systems
  • Experience in Upstream Processing
  • Experience with ATF Processing
  • Experience in Chromotagraphy, UFDF Operations
  • Experience with Column Packing
  • Intermediate mathematical skills
  • Clear, concise writing skills
  • Organizational skills
  • Basic problem-solving skills
  • Ability to interact constructively with peers
  • Ability to understand, applies, and evaluates basic chemistry, biology, and physical principles
  • Exhibits Amgen's values
  • Available for non-standard shifts including nights and weekends.
  • Degree In Chemical Engineering, Industrial Engineering or Life Sciences
  • Experience with Current Good Manufacturing Practices (cGMP)
  • Experience participating in cross-functional teams
  • Experience in managing multiple, competing priorities in a fast-paced environment
  • Strong scientific, technical interactions with partner organizations such as PD and F&E.
  • Experience in GMP Tech Support roles, GMP operations, process development or scheduling.
  • Experience with execution of Commissioning and Qualification, New Product Introduction, Cleaning Validation, and Process Performance Qualification
  • Experience with aseptic operations in Grade 5 (Class 100) cleanrooms.
  • Ability to organize, analyze, and interpret technical data through trend analysis, forecasting, modeling, etc. with excellent technical writing ability to convey processing events and conclusions
  • Background in lean manufacturing methodologies and operational excellence
  • Expertise in electronic systems used in manufacturing (MES/Werum, LIMS, Maximo, CCMS, etc.)


Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment.

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.