Engineer, Upstream/Downstream Drug Substance Process Development & Tech Transfer – REMOTE (JP15076) 3 Key ConsultingEngineer, Upstream/Downstream Drug Substance Process Development & Tech Transfer – REMOTE (JP15076)Thousand Oaks, CaliforniaRemoteOur ideal candidate will have 3+ years of experience in tech transfer of Biologics Drug Substance upstream and/or downstream required (Cell Culture, Harvest, Chromatography, filtration, UFDF unit ops), Knowledge of upstream and downstream processes/equipment; scale-up factors, process deviations, quality attributes. Biologics process knowledge: Knowledge of processes (cell culture, harvest, chromatography, viral filtration/inactivation, ultrafiltration/diafiltration, and final fill) and equipment; scale-up factors, process deviations, quality attributes.
Biostatistics Senior Manager, Biosimilars US- Remote Amgen IncBiostatistics Senior Manager, Biosimilars US- RemoteThousand Oaks, CARemotePlans and executes statistical contributions to protocols, randomization specifications, Statistical Analysis Plans (SAPs), Table, Listing and Graph ( TLG) shells, Submission Data File (SDF) specifications, other key-study related documentation, protocol deviations, Flash Memos, Clinical Study Reports (CSRs), and other communications in close partnership with CROs in a full-service CRO model. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
CQV Validation Engineer, Biotech GMP Equipment – Remote (JP15497) 3 Key ConsultingCQV Validation Engineer, Biotech GMP Equipment – Remote (JP15497)Thousand Oaks, CaliforniaRemoteThe role partners with Engineering, Manufacturing, Quality Assurance, Validation, and Maintenance teams to assess equipment performance, maintenance history, calibration status, deviations, change controls, and overall lifecycle management. Primarily responsible for planning, coordinating, executing, and documenting periodic reviews of GMP equipment to ensure continued state of validation, compliance with regulatory requirements, and suitability for intended use.
Engineer, Drug Substance Bioprocessing/Process Development & Optimization – REMOTE (JP15073) 3 Key ConsultingEngineer, Drug Substance Bioprocessing/Process Development & Optimization – REMOTE (JP15073)Thousand Oaks, CaliforniaRemoteHas the ability to manage projects independently, break down high level projects into smaller incremental tasks, and elevate relevant issues to project lead and line management. Preference for candidates with previous experience in tech transfer, process development, clinical or commercial scale manufacturing, Experience leading or supporting business process optimization/ continuous improvement projects.
Field Support Specialist - Remote (California) Goodman ManufacturingField Support Specialist - Remote (California)Camarillo, CARemote$92,430–$116,050 / yearProvide information and conduct training sessions pertaining to proper installation techniques, equipment commissioning, controls commissioning and troubleshooting of Daikin's HVAC indoor units, outdoor units, controls and accessories for key Distributors, Daikin Comfort Pro's, Amana/Goodman Premium Dealers. As a Field Support Specialist, you will be responsible for providing installations, installation and technical service assistance, equipment commissioning, controls commissioning, and occasional warranty support for Daikin HVAC product line (FIT/S-Series/Side Discharge/RA_QA).