Amgen Associate Manufacturing in Thousand Oaks, California
The Amgen Thousand Oaks, Building 20 Drug Product Manufacturing facility directly supports Amgen's pipeline of clinical drug product supply to patients across the globe. The Associate Manufacturing - Drug Product role offers the opportunity to collaborate with multiple functions within the Thousand Oaks site on a routine basis in a dynamic environment (Quality Assurance, Quality Control, Engineering, Facilities, Maintenance, Process Development, Process Engineering, etc.) while developing a deep understanding of the manufacturing operations and planning activities within the facility.
In this role, you will work with a team responsible for supporting multiple Drug Product manufacturing operations, including formulation, sterile-isolator filling, aseptic filling, and lyophilization activities. The team is responsible for maintaining the highest levels of safety, quality, compliance, and efficiency while balancing a dynamic production schedule. You will work cross-functionally to support multiple customers and stakeholders including Supply Chain, Quality Assurance, Process Development, and Engineering.
The Senior Associate Manufacturing will be specifically responsible for:
Executing drug product filling and formulation activities, respectively
Performing initial review of manufacturing batch records
Maintaining a safe and compliant culture by identifying preventative measures
Creating and/or revising standard operating procedures
Leading continuous improvement initiatives, which may be cross-functional in nature
Performing data analysis (e.g., SPC, CPV) of critical process parameters and making recommendations to Engineering and/or Process Development teams
Developing finite schedule for tasks including, but not limited to unit operations
Monitoring productivity and identifying countermeasures for issues impacting cycle time adherence
Elevating critical and impactful events to management
Utilizing appropriate systems for job duties (SAP, QMTS, and LIMS etc.)
Supporting the introduction of new products and technologies into the facility
Initiating and owning quality records, including but not limited to non-conformances (NC), Corrective/Preventative Actions (CAPA)
Master's degree OR
Bachelor's degree and 2 years of biotech or pharmaceutical product manufacturing, process development or quality experience OR
Associate's degree and 6 years of biotech or pharmaceutical product manufacturing, process development or quality experience OR
High school diploma / GED and 8 years of biotech or pharmaceutical product manufacturing, process development or quality experience
At least 5 years of biopharmaceutical experience, with 3 years of experience directly within drug product manufacturing, which includes aseptic and sterile filling environments, as well as lyophilization
Bachelor's or Master's degree in Microbiology, Life Sciences, Business or a related field
Strong working knowledge of Lean concepts and application within a regulated manufacturing environment
Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality.
Basic project management skills
Demonstrates emergent leadership traits and strong cognitive problem solving skills
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.