Associate Mfg - AFP
|Location:||Thousand Oaks, California|
Under minimal supervision, the Associate Manufacturing will routinely perform complex process in fill finish pilot facility and/or clinical manufacturing area. Individual will be primarily responsible for executing filler characterizations studies on a pilot filler in a process development lab. In addition, the individual may be directly involved in manufacturing of sterile products in aseptic environment.
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.
Onsite for Thousand Oaks, CA
Regular Hours M-F
Additional workload on the team.
Biopharmaceutical experience drug product manufacturing, which includes aseptic and sterile filling environments, as well as lyophilization Experience executing process characterization studies and providing insight for areas of improvement. Strong aptitude in creating standard operating procedures, job aides, and maintaining metrics associated with the respective drug product manufacturing processes. GMP Experience
Executing drug product filling and formulation activities, respectively within the pilot plant facility, as well as the clinical drug product manufacturing facility 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)
Gain GMP Experience at Client
Over qualification is a real risk, as the selected person will be primarily responsible for performing hands-on tasks within a manufacturing environment.
One phone and one in-person