Associate Scientist- Vector Manufacturing

Found in: Appcast Linkedin GBL C2 - 2 weeks ago


Seattle, United States Integrated Resources, Inc ( IRI ) Full time

TOP SKILLS

  • The candidate must have demonstrated verbal, written, and communication skills including ability to present complex information clearly and concisely, with a successful proven history of working with technical teams.
  • Experience should include management of lab activities, technical support of a cGMP manufacturing facility, including strong knowledge and engineering leadership for viral vector manufacturing and processing equipment, and process characterization.
  • Prefer experience with leading experiments and designing DOEs
  • Prior experience in/knowledge of cell culture, viral vector manufacturing, recovery and/or purification of viral vector product in a manufacturing environment preferred

Duties/Responsibilities:

  • Oversee lab activities and schedule
  • Design studies to support commercial manufacturing deviation investigations.
  • Support the the execution of process characterization studies.
  • Collaborate with commercial vector team to identify opportunities for process improvements, make formal recommendations.
  • Lead identification and implementation of new technologies and procedures from Development into Manufacturing
  • Lead efforts focusing on alignment and harmonization of manufacturing process across multiple sites
  • Support the hands-on training of commercial process unit operations to Vector MS&T
  • Identify, design and manage small capital engineering projects

Specific Knowledge, Skills, Abilities, etc:

  • The candidate must have demonstrated verbal, written, and communication skills including ability to present complex information clearly and concisely, with a successful proven history of working with technical teams.
  • Experience should include management of lab activities, technical support of a cGMP manufacturing facility, including strong knowledge and engineering leadership for viral vector manufacturing and processing equipment, and process characterization.
  • Prefer experience with leading experiments and designing DOEs
  • Prior experience in/knowledge of cell culture, viral vector manufacturing, recovery and/or purification of viral vector product in a manufacturing environment preferred
  • Prior experience with SOPs, cGMPs and how they are applied within a regulatory environment required
  • Prior experience participating in process characterization preferred

Education/Experience/ Licenses/Certifications:

  • Degree in Biology, Chemistry, Biochemical or Chemical Engineering, or equivalent area of related experience in biologics upstream manufacturing
  • Preference given to candidates with experience performing process characterization
  • Knowledge of cellular immunology and/or vector manufacturing a plus
  • Experience with cGMP, ICH guidelines, PPQ (process validation), control strategy development, and working within a Quality organization
  • Proficiency utilizing MS Office products and working knowledge of statistical software (R, JMP, Minitab)
  • Experience working in a self-driven, performance/results oriented, fast paced matrix environment
  • Experience writing experimental plans and protocols



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