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Senior Scientist, Quality Control Person in Plant (PiP)

Company: Knewin
Location: San Francisco
Posted on: February 12, 2024

Job Description:

About the role Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who want to challenge status quo, and who lead with the desire to work on novel ideas. As a Sr. Scientist, Quality Control Person in Plant (PiP), you will report to Head of Corporate Quality Control to oversee day-to-day quality control activities at Sana's key contract development and manufacturing organization (CDMO). This will include coordinating with the Quality Control (QC) team to provide oversite and guidance at the CDMO for Sana's cell therapy programs. You will be an essential business partner with Technical Operations and will support Sana's quality control team and bring Sana's pipeline to patients across the world. What you'll do

  • Responsible for all quality control-related matters related to manufacturing, testing, and release at CDMO
  • Act as a primary quality control liaison between Sana's internal technical functions and the CDMO for drug substances and cellular drug products to ensure success of assay qualification activities at the CDMO
  • Partner with Sana's internal technical functions to align on assay transfer strategies and coordinate with the CDMO to provide onsite oversite and support QC as Person-in-Plant (PiP)
  • Identifies, notifies, and/or escalates risks and issues that may impact program timelines, resource requirements, finances, or business relationships
  • Represent Quality Control at internal and external project team meetings and build relationships with Quality Control counterparts at CDMO
  • Collaborate with Sana and CDMO Manufacturing, QA, and Process Development teams to evaluate and investigate issues
  • Ensure CDMO delivers to support Sana's business needs, including flexibility to accommodate changing program timelines and compliance with GMP practices as well as Sana's Quality expectations What we're looking for
    • PhD in Cell Biology, Molecular Biology, Immunology, or a related scientific discipline w 5+ yrs experience in academic research and/or industry. BA or MS plus 8+ yrs or equivalent combination of education and work experience
    • Deep subject matter expertise in Quality Control. You will have demonstrated experience, leadership, and independence with QC functions associated with the GMP production and testing of cell/gene therapy products or biologics in both clinical and/or commercial settings
    • Experience in performing phase-appropriate assay qualification/validation in a GLP or GMP environment
    • Experience in transferring assays from internal AD to QC teams and externally to a CDMO
    • Knowledge and understanding of regulatory guidelines from the FDA, ICH, USP, EP, etc.
    • Excellent written and oral communication skills
    • Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
    • Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues. Ability to communicate issues with CDMO
    • Goal oriented with the ability to troubleshoot and resolve problems
    • Successful track record of developing cooperative, productive relationships across all functions with people at all levels within and external to the organization
    • High degree of self-motivation What will separate you from the crowd
      • Experience at a startup or pre-clinical biotechnology company; cell or gene therapy experience is a plus. Experience in taking program at CDMO into late stage
      • Technical expertise in any of the following areas: multi-color flow cytometry assays, cell-based assays for potency, viral titer assays, or molecular assays utilizing ddPCR and/or qPCR What you should know
        • Up to 50% travel is required
        • Working in BSL-2 and BSL-2+ labs is required
        • Occasional weekend work is required
        • The base pay range for this position at commencement of employment is expected to be between $140,000 and $170,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience How we work together
          • Lead from every seat - we seek to understand, act with honesty, and engage in the crucial conversations
          • Thrive as a team - we hire amazing people, are intensely curious, and cultivate inclusion and personal connectivity
          • Make it happen - we value vigorous debate, alignment around our decisions, and resilient execution Get to know us At Sana,we believe that a diverse workforce strengthens us as a company and helps us to achieve our mission to meaningfully change the outcome of many human diseases. This belief is a pillar of our business and is critical to our success. Our goal is that Sana istheplace for talented people to bring their authentic selves to work, to have a great career and to deeply, positively impact patients. Core to our values, we believe there is nothing more important than the health and wellness of you and your family. For benefit eligible employees, we cover 100% of the cost for employee health coverage and offer generous time-off (various paid time off benefits, such as holidays,vacation, sick time, and parental leave), short- and long-term disability, employer paid basic life insurance, additional voluntary life insurance protection, financial wellness programs including financial planning resources, a 401(k) Plan with an immediately vested employer match, Tuition Reimbursement and Student Loan Repayment, Employee Stock Purchase Plan, commuter subsidy and a variety of wellness offerings to support each person individually. For more details on our benefits, visit Sana's Benefits Portal . We are committed to providing a workplace free of discrimination and harassment based on race, color, religion, age, gender, national origin, ancestry, physical or mental or sensory disability (including the use of a trained guide dog or service animal by a person with a disability), genetic information, actual or perceived HIV or Hepatitis C infection, medical condition (cancer or a record or history of cancer and genetic characteristics), marital status, sexual orientation, sexual preference, pregnancy (including childbirth and related medical conditions), disability, veteran status, political ideology, social class (including caste/caste identity), taking or requesting statutorily protected leave, status as a victim of domestic violence, sexual assault or stalking, or any other basis prohibited by applicable law. To perform this job successfully, you must be able to perform each job responsibility satisfactorily. The job description listed above is representative of the knowledge, skills, and/or abilities required for this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions described above.
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Keywords: Knewin, San Francisco , Senior Scientist, Quality Control Person in Plant (PiP), Professions , San Francisco, California

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