Sr Associate Mfg
This Manufacturing Senior Associate position will support the commissioning and start-up of commercial cell culture and purification of drug substance intermediate manufacturing operations in Thousand Oaks, CA. The Sr. Associate will coordinate and lead production operations on the manufacturing floor including taking a lead role in the commissioning and qualification of process equipment. This role is a key communication and technical interface between the GMP manufacturing teams in the plant and our partner organizations.
Job scope and responsibilities:
- Lead manufacturing operations on the production floor. Ensure all safety and compliance procedures are followed at all times.
- Participate in the development, execution, and issue resolution associated with process equipment Commissioning, Qualification and Validation.
- Provide troubleshooting, technical support, and resolution of equipment, automation, and process issues on the manufacturing floor.
- Write, revise, and own controlled documentation (SOPs, Manufacturing Procedures (MPs), Forms, Technical Reports, etc)
- Serve as SME for Cell Culture and/or Purification operations including cleanroom Aseptic Technique. Provide training to manufacturing staff on process and equipment.
- Own Non-Conformances (NC) and Corrective and Preventive Actions (CAPA)
- Champion Lean Transformation and OE initiatives, facilitate the drive towards continuous improvement in the plant, and track progress on a plant level.
- Collaborate with Quality, Engineering, Process Development, Validation, and Operations to resolve manufacturing events in a timely manner.
- Assure appropriate escalation to various levels of management when personnel and environmental safety, equipment functionality, product supply, or quality are at risk.
- Collaborate with Quality, Mfg Managers, Plant Engineering, Process Development and Regulatory Compliance staff in cross-functional teams.
- Apply advanced process, scientific, operational, and compliance knowledge with analytical and troubleshooting skills to support manufacturing operations.
- Participate in the design, development, and implementation of processes in support of the manufacturing floor.
Bachelor's degree and 2 years of biotech or pharmaceutical manufacturing, process development or quality experience
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
- Degree in Chemical Engineering, Industrial Engineering or Life Sciences
- Technical understanding of drug substance intermediate Cell Culture and Purification operations
- Experience with Current Good Manufacturing Practices (cGMP)
- Ability to be flexible and manage change
- Experience participating in and leading 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.
- Technical knowledge of Upstream Drug Substance Intermediate processing and broad understanding of related disciplinary areas - Bioreactors, Roller Bottles, UFDF.
- 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.