Amgen

Sr. Associate Mfg.

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Sep 08, 2019
Ref
R-76466
Required Education
High School or equivalent
Position Type
Full time

The Manufacturing Senior 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 Senior 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 and revision of documentation for assigned functions. The Senior Associate Manufacturing will participate on cross-functional teams, have the responsibility of owning NC/CAPAs, and will 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

Comply with cGMP's

Analytical testing to support production, including pH, cell counting, protein concentration, etc.

Revise controlled documents (e.g. MPs, SOP's, and technical reports)

Initiate and Close Minor Deviations

Identify and recommend improvements to operations, and implement after approval

Basic troubleshooting

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

May act as safety representative

Ability to be flexible and manage change

Basic Qualifications:

Master's degree

OR

Bachelor's degree and 2 years of biotech or pharmaceutical manufacturing, process development or quality experience

OR

Associate's degree and 6 years of biotech or pharmaceutical manufacturing, process development or quality experience

OR

High school diploma / GED and 8 years of biotech or pharmaceutical manufacturing, process development or quality experience

Preferred Qualifications:

  • 5 years' experience in a biomanufacturing environment
  • Experience in Single Use and legacy Cell Culture and/or Purification Processing
  • Experience and troubleshooting skills with laboratory and process equipment
  • Experience with DeltaV, OSI PI, LIMS, TrackWise
  • Understand, apply and evaluate basic chemistry, biology and physical principles
  • Subject Matter Expert on at least one related unit operation
  • Experience interacting with inspectors (internal and external)
  • Experience working under current Good Manufacturing Practices (cGMP)
  • Excellent written and oral communication skills
  • Strong organizational and problem-solving skills
  • Degree in life sciences, chemistry, or engineering
  • Experience participating in and leading cross-functional teams
  • 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.
  • Background in lean manufacturing methodologies and Operational Excellence
  • Available for non-standard shifts including nights and weekends.

 


Join Us
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.

Join Us

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.