Job Description Day-to-Day:

• Lead and execute regenerative medicine research and development projects
• Design, conduct, and oversee laboratory experiments, analytical testing, and assay development activities
• Manage multiple research programs, new product development initiatives, and specialty projects
• Develop tissue-engineered products and regenerative medicine solutions
• Establish Target Product Profiles (TPP) and Critical Quality Attributes (CQA) with internal and external stakeholders
• Utilize Quality by Design (QbD) and Design of Experiments (DoE) methodologies to optimize processes and reduce costs
• Support technology transfer, process scale-up, industrialization, and GAP analysis activities
• Investigate deviations, troubleshoot technical issues, and assess product impacts
• Develop and maintain cGLP documentation, SOPs, protocols, and quality records
• Perform stem cell expansion, differentiation, characterization, and cryopreservation activities
• Conduct extracellular vesicle isolation, processing, characterization, and analytical testing
• Collaborate with regulatory agencies, industry partners, suppliers, and cross-functional teams
• Author scientific publications, abstracts, technical reports, and grant applications
• Participate in audits, inspections, strategic planning initiatives, and continuous improvement efforts
• Represent the organization at regional, national, and international scientific forums and conferences
• Team of 5 in R D, including leadership (3 scientists below the Director).
• Collaborates primarily with the Production team when utilizing manufacturing and laboratory equipment.

• Environment:

  Highly collaborative team. Team members assist each other with cell culture, media changes, and laboratory work when needed. Strong "all hands on deck" mentality.
• Individual contributor with no direct reports.
• Approximately 70% laboratory work, 30% data analysis and documentation.
• Supports tissue engineering and regenerative medicine projects.
• Works on patented projects involving cell expansion using microcarriers in bioreactors.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.

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https://insightglobal.com/workforce-privacy-policy/. Skills and Requirements

• PhD with 3+ years of industry/research experience OR
• Master's degree with 5+ years of relevant experience.
• Hands-on experience in regenerative medicine and/or tissue engineering.
• 3-5+ years of experience with one or more of the following: Mesenchymal Stem Cell (MSC) culture, Induced Pluripotent Stem Cells (iPSCs), Stem cell differentiation, Potency assays, Isolation of cells from tissue, Microcarrier-based cell expansion, Tissue engineering applications
• Hands-on experience with some or most of the following: Bioreactors for cell expansion, Microcarrier-based culture systems, ELISA assays, Tissue dissociation/separation equipment, Cell culture and stem cell processing equipment
• Experience performing or supporting one or more of the following: Tri-lineage differentiation assays, Stem cell differentiation assays, Cell viability assays, Fluorescence microscopy, Cell characterization assays
• Experience scaling MSCs or iPSCs using microcarrier-based expansion in bioreactors.
• Experience with extracellular vesicles (EVs) and/or exosomes.
• Assay development experience.
• Quality documentation experience (SOPs, validation documentation, cGMP/cGLP environments).
• Experience with flow cytometry, PCR, or other cell characterization techniques.
• Technology transfer or process development experience.
• Experience collaborating with manufacturing/production teams in a laboratory environment.