Senior Scientist - Cell Therapy Process Development

  • Location

    California, USA

  • Sector:

    Life Sciences

  • Job type:

    Blijvend

  • Salary:

    Negotiable

  • Contact:

    Hanaa Sammra

  • Contact email:

    Hanaa.Samrra@voltinternational.co.uk

  • Job ref:

    BBBH1115_1627047325

  • Published:

    4 maanden geleden

  • Expiry date:

    2021-08-24

VOLT are currently assisting an early stage cell & gene therapy biotechnology company based in California who have break through scientific approach for patients suffering with rare diseases. We are seeking a highly motivated Senior Process Development Scientist to join our Multidisciplinary team to support the development of novel cell therapies with the use of cell and gene therapies.

Responsibilities
*Optimize process and procedures to assess quality of product and effectiveness of manufacturing
*Supervising clinical materials based on cGMP standards
*Meeting project deadlines
*Supporting senior management with projects
*Oversee and execute development of new cell therapy processes and procedures to produce products in support of IND-enabling studies and clinical studies in humans
*Supporting the writing of the investigational new drug and chemistry manufacturing control

Qualifications:
*Bachelor's degree or Master's degree in Biological Sciences
*10+ years of experience within the biopharmaceutical industry / Ph.D. with 5+ years of biopharmaceutical industry experience
*Experience in cell therapy process development at clinical stage
*Ability to design and execute large scale process development engineering optimization experiments
*Awareness of cGMP requirements and working within a regulated environment
*Ideal development and technology transfer of cell therapy products
*Viral and non-viral transduction principles and procedures
*Knowledge of Design of Experiment (DOE) and Quality by Design (QBD)
*Exceptional communication and written skills and ability to multitask within a fast-paced environment