• Job Description

  This is an exciting opportunity responsible for overseeing Manufacturing Sciences & Technology (MS&T) related drug product and fill/finish technology transfer and manufacturing activities for biologics manufacturing. You will be charged with overseeing the following activities:

  
  

  * Leading MSAT staff and projects relating to drug product manufacturing operations.

  * Providing technical leadership and subject matter expertise relating to drug product fill & finish related deviations, change control, process optimization, and technical troubleshooting.

  * Handling of complex and highly automated systems and overseeing all state-of-the-art equipment including formulation, aseptic liquid filling, pre-filled syringe lyophilization, and  packaging apparatus.

  * Working cross functionally with Process Development, Manufacturing, Regulatory, Quality, and Engineering Services departments to lead drug product fill & finish related process improvement, process validation, process change control, deviation investigation and process characterization activities. 

  * Serving as a technical/scientific Subject Matter Expert drug product fill & finish activities.

  * Defining, designing and developing critical process capability, critical process parameters, and process performance measurements through multivariate modeling and statistical measurements of Cp, Cpk, Pp, and Ppk.

  * Training engineering staff on cGMP compliance and SOPs including writing/reviewing batch records, process validation documents, and sections of regulatory filings.

  * Assisting in the build-out of BioPharma Manufacturing Data Systems, Process Intelligence, and Process Monitoring systems.

  Desired Skills and Experience

  * BS in Biochemical Engineering, Chemical Engineering, Biochemistry, Biology, Chemistry or related Life Sciences/Engineering field.

  * 6-10+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience.

  * Experience leading projects relating to manufacturing deviations, change control, process optimization, technical troubleshooting, and manufacturing process changes.

  * Experience with high speed aseptic liquid filling of vials, aseptic lyophilization filling of vials, and aseptic preparation of pre-filled syringes through capping, bottling, and packaging processes.

  * Strong experience working cross functionally within a BioPharma Manufacturing organization leading projects across Process Development, Manufacturing, Regulatory, Quality, and Engineering Services departments.

  * Strong Scientific and Engineering technical experience performing fill & finish manufacturing activities from formulation through packaging activities. 

  * Expertise involving QbD (Quality by Design), scale down studies, process range studies, PAT, statistical analysis, process robustness studies, and Six Sigma.

  About this company

  This is an exciting opportunity to join a major BioPharma and Vaccine company rapidly developing and commercializing novel vaccines including a vaccine for COVID-19.
  

  Apply Here: by dragging your Microsft Word resume into this yellow box.
  OR you can click the green Apply Now button on the top right of this page to browse for the file.

  
  

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