Looking to Grow with a Company? Senior Bioprocess Scientist Miami, FL · Full time

OrganaBio is seeking an experienced Senior Bioprocess Scientist to collaborate with cross-functional teams, to participate in the development and production of novel research use and cGMP grade cell and cell-based materials for cell therapies. This position will ensure that products will be developed and manufactured under GLP and GMP practices, will participate in tech transfer from Process and Product Development (PPD) to Manufacturing and customers, and will support the Manufacturing program and Business Development team with technical support

Description

  • Deliver on scientific goals in support of corporate objectives, under the direction of the Management Team
  • Lead the development and optimization of robust and scalable processes for product manufacture (including multiple adherent and non-adherent cell types), using 3D bioreactors of various scale, progressing from research- to commercial-scale bioreactors
  • Lead the development and characterization of novel products that include extracellular vesicles, using translation-ready and scalable production systems
  • Contribute to the development of new, custom, or existing products, with reasonable cost of goods, and according to established project timelines
  • Contribute to Scopes of Work and project execution for OrganaBio Partner Programs
  • Work independently and with a level of functional expertise necessary to influence and execute product technical development
  • Participate in the design and lead the assessment of critical process parameters and process / product characterization utilizing methods that include, but are not limited to, FLOW analysis, ELISA and ELISA-based methods, multi-plex assays, histological assays, etc
  • Collaborate with Quality Control to establish appropriate critical to quality (CTQ) metrics and validated assessment methods
  • Analyze accumulated data to streamline process/product development and consistently report out to Management Team
  • Write and review technical reports and Standard Operating Procedures
  • Manage technology transfer from PPD to Manufacturing and lead Manufacturing in troubleshooting production issues with standard and specialized products
  • Serve as a Subject Matter Expert and liaison to Process Development, Manufacturing Science and Technology (MSAT), Manufacturing, and Business Development
  • Supervise/coach scientists and cell processing specialists and help manage routine team operations
  • Work closely with other functional teams in a matrix organization to move projects forward
  • Provide regular production status updates to PD, MSAT, and Manufacturing teams
  • Support external audits and inspections, as required
  • Support daily laboratory operations, including cleaning, maintenance, ordering, and inventory management
  • M.S. in an applicable field (Bioengineering, Chemical Engineering, Biological or relevant process related sciences) with 5+ years of experience, or 7+ experience in an applicable field
  • Extensive cell culture experience required
  • Minimum 5 years of experience in process development and/or GLP/GMP manufacturing of cell and gene therapy products
  • Basic understanding of cell biology, immunology, bioprocess and engineering principles
  • 2 years of experience with primary cell isolation and aseptic techniques.
  • Experience with birth tissue-derived cells (MSCs, HSCs, immune cells) a plus
  • Experience in a GLP and/or GMP manufacturing setting a plus
  • Well-honed analytical skills and knowledge of statistical software to conduct data analysis
  • Strong experience in upstream and downstream cell processing and culture technologies in support of the finished materials production
  • Bioreactor process development experience a plus


It is strongly preferred that successful applicants for positions are fully vaccinated against COVID-19.


OrganaBio is an Equal Employment Opportunity employer. OrganaBio prohibits any form of unlawful harassment or discrimination against applicants for employment or employees on the basis of any legally protected status entitled to protection under federal, state, or local law.


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