Amgen

Sr Mgr Process Development

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Aug 09, 2019
Ref
R-76340
Required Education
High School or equivalent
Position Type
Full time
The Amgen Thousand Oaks Cellular Sciences department is seeking an enthusiastic, highly motivated,

and team-oriented individual for the position of Process Development Senior Manager, to join and lead our Cell Bank MFG/Critical Reagents group. The Senior Manager will provide scientific, technical and managerial leadership in support of the team's key responsibilities which include:
  • Meet site demands for cell bank production for clinical and commercial programs in the cGMP cell bank manufacturing area
  • Development, characterization, storage and distribution of critical reagents including but not limited to Antibodies (polyclonal and monoclonal), Host Cell Proteins, Process Impurities, Bioassay Reagents and DNA Reagents
  • Generation of Ready-to-plate (RTP) cell banks for QC Bioassays and troubleshooting
  • Regulatory Support for issues related to Critical Reagents or Cell Banks
  • Identification and Implementation of technologies to improve efficiencies, enabling of new processes and platform processes


Reporting to the Director of Cellular Sciences, the Sr Manager will manage a team of scientists and associates and contribute to the strategic direction of the group based on industry trends, future requirements and feedback from key partners as well as regulatory requirements.

Job Summary:
  • Leads a high performing team with diverse scientific disciplines
  • Responsible for management and oversight of manufacturing production area
  • Ensures that clinical and licensed products are produced according to current Good Manufacturing Practices and other applicable regulations
  • Forms partnerships with clients in order to proactively provide high quality, well-characterized, long-term supplies of critical reagents
  • Will effectively interface with partners in Process Development, Quality, Translational Sciences and Regulatory to align on activities in all development stages and compliance
  • Advance the organizations acumen on GMP compliance and current regulatory trends and expectations
  • Executes with a sense of purpose and drives course corrections where appropriate
  • Recruit and retain highly capable staff that can deliver in a highly matrixed and dynamic environment


Basic Qualifications

Doctorate degree and 2 years of manufacturing or operations experience
OR
Master's degree and 4 years of manufacturing or operations experience
OR
Bachelor's degree and 6 years of manufacturing or operations experience
OR
Associate's degree and 10 years of manufacturing or operations experience
OR
High school diploma / GED and 12 years of manufacturing or operations experience

Preferred Qualifications
  • 6-10 years relevant laboratory experience in a Biotechnology or Pharmaceutical company setting
  • Experience in Cell Banking operations, protein purification and bioassays is a plus
  • Excellent interpersonal skills and managerial experience
  • Demonstrates a high level of skill and competency
  • Excellent communication and presentation skills to various audiences
  • Well versed in cGMP practices and compliance
  • Experience participating in and responding to corporate audits/regulatory inspections
  • Ability to demonstrate leadership attributes, flexibility and change management
  • Conflict resolution capability
  • Direct experience driving process improvements and innovation


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.