Director of Cell and Gene Therapy

Location
Milpitas
Posted
Aug 06, 2018
Ref
864748
Required Education
Doctorate/PHD/MD
Position Type
Full time

JOB DESCRIPTION

The individual will be part of a strategic and dynamic gene and cell therapy group that is highly focused on the rapid development of new therapeutic treatments of rare genetic diseases. We look for a highly energetic individual who has deep technical knowledge in Cell and Gene Therapy space to be a strategic leader responsible for technical development to lead and expand our current preclinical programs.

In addition to technical expertise, the ideal candidate should also possess the ability to successfully interface with multidisciplinary teams, engage and collaborate with external partners, and be comfortable making decisions independently. Effective oral and written communication skills is important.

RESPONSIBILITIES

1. Influence, lead and manage all project/network/platform activities and apply scientific and technical expertise and leadership to direct research and discovery of Cell and Gene therapy programs.

2. Coordinate interdisciplinary projects and teams, including related projects and initiatives with a direct impact on Cell and Gene Therapy development operations.

3. Define product development plans that include budget and timeline for the therapeutic research and drive the implementation of technical strategy and capabilities to achieve the final goals

4. Collaborate with late stage development and regulatory teams. Provide technical support in IND filing.

5. Build and develop talent, and drive a continuous improvement mindset in the organization

 

QUALIFICATIONS

PhD with 8+ years of relevant experience.

Technical expertise in the Cell and Gene Therapy is a must. Experience in AAV-based gene therapy and/or stem cell-based gene therapy is required.

A background in project management and pharmaceutical industry is highly preferred.

Familiar with regulatory and requirement in the Cell and Gene Therapy space is a plus.

Experience in gene editing is a plus

 

Job responsibilities

1. Cell Manipulation and Genome Editing

  • Develop and establish standard operating procedures for cell culture and genome manipulations in primary cells (mesenchymal stem cells, hematopoietic stem cells and lymphocytes). Research and perform on cell manipulation procedures which include but not limited to genome editing procedures, cell culture and transfection, selection and clonal expansion and scale-up, stem cell and/or cellular product cryopreservation, cell enrichment, cell evaluation and sorting, cell product thaw/wash and preparation for infusion.
  • Establish procedures to comply with FDA’s Good Manufacturing Practice (GMP) regulations as well as standards set by other accreditation agencies. Develop in vivo and in vitro assays such as PCR, next-generation sequencing-based or ELISA-based assays, immunohistochemistry, and etc.
  • Develop gene and cell therapy strategies towards clinical products. Demonstrate and maintain working and theoretical knowledge of up-to-date stem cell and gene therapy trend and technology advancement.
  • Document diligently on all experimental designs, protocols, data collection, and reports.

2. Proof-of-concept in vivo experiments

  • Perform preclinical animal experiments including intravenous injection, blood/tissue collection, bone marrow transplantation, and intra-bone injection.  

3. Collaborative Teamwork

  • Collaborate and communicate internally with other team members as well as with external collaborators.  
  • Transfer of technologies and procedures to other team members and collaborators’ institutions and companies, training of technologists and writing Standard Operating Procedures.

4. Perform additional related duties as needed and assigned.

Core competencies

  • Gather relevant information systematically; break down problems into simple components and make sound decisions.
  • Approach problems with curiosity and open-mindedness; and offer new ideas, solutions and/or options.
  • Demonstrates a high level of responsibility and a commitment to excellence, ethical practice and on-going professional development. Adhere to legal and regulatory requirements.
  • Possess teamwork spirit and show concerns to other team members.
  • Prioritize and strive to meet deadlines.

Requirements:

PhD in biology/medical field such as molecular and cell biology, biochemistry, immunology, or hematology. Experience with animal models is required.

Preferred: 3+ year experience in primary cell, hematopoietic stem cell or lymphocyte cell culture and manipulation, genome editing, flow cytometry techniques, hemophilia or thalassemia are highly desirable.

The successful applicant will thrive in a fast-paced team environment developing translational gene editing-based Cell and Gene Therapy.