Organovo seeks a highly-motivated Process Development Scientist
As part of the process development team, the individual will work closely with the Research, Engineering, Quality and Manufacturing Groups to develop and transfer robust cell culture and tissue fabrication processes that are scalable for manufacturing. The individual's primary responsibility will be to provide technical expertise and leadership to the development, scale-up, transfer, and support of manufacturing operations.
•Develop and optimize processes for expansion and usage of primary human anchorage-dependent cells:
•Robust large-scale growth processes including evaluation of large format culture-ware and bioreactor systems
•Cell cryopreservation techniques
•Working in conjunction with Engineering for continued process improvement of core technology
•Raw material qualification and Process Validation for the manufacture of tissues
•Identification and / or development of in-process assays to characterize cells and tissues including, cell phenotype, secretome, metabolic, and molecular
•Improve manufacturing processes for current products (to improve product quality, output and/or generate cost savings)
•Product development and transfer of new products from Research to Manufacturing
•Communicate functional area and departmental results in cross-functional settings
•Write protocols and development / technical reports to support process changes.
•During technical transfer, provides technical review of design documents
•Prepare SOPs and Batch Records that enable transfer of validated protocols into Manufacturing.
Process Development Scientist Skills & Experience:
•A degree in Bioengineering, Science, or Biochemical Engineering or a related field and having direct process/product development experience in a FDA or ISO commercial setting
•BS with 8+ years of experience
•MS with 4+ years of experience
•PhD with 2+ years of experience mammalian cell culture in a commercial setting.
•Experience with mammalian cell culture required
•Experience in use of MS Office Suite and data analysis software (e.g. MiniTab, GraphPad Prism)
•Experience in applying standardized root cause analysis, investigation tools and methodologie
•Experience with anchorage dependent primary human cells is a plus.
•Design control experience in a GLP or GMP environment
•Experienced in process and/or equipment validation
•Statistical expertise is a plus Key Attributes
•Candidate must demonstrate strong interpersonal skills and the ability to integrate into a cross-functional team based organization.
•Candidate must demonstrate a strong ability to set and meet deadlines, multitask and prioritize resources based on project needs.
•Candidate must demonstrate scientific excellence with sound approach to experimental design and data interpretation.
•Candidate must be self-motivated, able to work independently, and be a good team player.
•Candidate must have superior organizational skills with great attention to detail.
•Candidate enjoys hands on work in a laboratory / cleanroom setting.
•Candidate must have excellent oral and written communication skills.
•Adjust rapidly to shifting priorities and variable workloads and is able to work flexibly to accommodate project deadlines. We offer a competitive salary and benefits package as well as the opportunity to join a dynamic, high-performing team. #CB
DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by incumbents assigned to this job. This is not intended to be an exhaustive list of all the functions, responsibilities, duties and skills required for the position, and Organovo retains the discretion to modify functions, responsibilities, duties and skills at any time, including modifying the time devoted to such activities, deleting activities, and assigning other activities.
Organovo is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact us at 858-224-1057 for assistance.