(Senior) Scientist, Cell and Gene Therapy Technologies

Location: London, UK

Reporting to: Principal Scientist, Cell and Gene Therapy Technologies
Permanent & Full time

This an exciting opportunity for a well-qualified candidate to join a rapidly growing international company focused on transforming the lives of patients with rare disorders through innovative gene therapies.

Orchard Therapeutics, Ltd. (OTL) is looking for a (Senior) Scientist for the Cell Process Development team to manage activities related to the development, manufacture and delivery of Orchard Therapeutics innovative gene-modified cell-based therapeutic products. Primary activities will include the process development and optimisation of our drug product manufacturing process, investigating all manufacturing process steps including cell selection, transduction, culture, and formulation. Research will be conducted both internally and with external partners, from pre-clinical research through to commercialization. The post may also include tech-transfer, validation and GMP execution of manufacturing processes and controls to support OTL's product pipeline programs.

The job position is for Senior Scientist or Scientist, depending on experience.

Key Elements and Responsibilities

• Involvement in the transfer of cell processes and controls from academic and external collaborators to the cell processing team.
• Design and implement improvements in processes and characterize HSC-based gene modified cell processes to deliver robust platform processes suitable for early and late-stage clinical and commercial development.
• Provide expert compilation, review, editing and approval of batch records, standard operating procedures, development protocols and reports.
• Design and perform experiments and data analysis, and prepare reports required and suitable for regulatory submissions.
• Co-ordinate development activities with the research, pre-clinical development, QA, QC, clinical development and commercial departments to ensure the successful achievement of company timelines and milestones.
• Assist in lab management duties, stock management and equipment maintenance.
• As required, assist with oversight of manufacturing at company designated Contract Manufacturing Organizations (CMOs).
• Other activities as may be assigned.

Requirements

Required Knowledge

As a proven technical expert in the development, manufacture and delivery of cell-based therapy products with ideally with applied experience in the biotechnology industry, this candidate will possess:

• PhD in biotechnology/biological sciences or equivalent experience in industry with a primary focus on the development, manufacture, distribution and delivery of cell and gene-based therapy products.
• 2+ years of relevant biotech or pharma industry experience in cell and gene therapy products or related areas
• Technical experience with a proven track record of developing, integrating and implementing equipment and processes for clinical and/or commercial application:
  • Cell isolation/purification
  • Cell culture
  • Cell transduction
  • Cell washing/volume reduction
  • Formulation and final fill of cell-based products
• In depth expertise of gene therapy vectors and autologous gene modified cellular therapies
• Experience or understanding of regulatory filings and associated reports/sections writing and knowledge of FDA, EMA, GMP and ICH regulatory requirements a plus
• DOE and QBD experience a plus

The ability to travel domestic and international

Skills and Abilities

• Excellent interpersonal skills
• Outstanding organizational skills
• Excellent written and oral communication skills
• A minimum PhD or equivalent, in bioprocessing, biological sciences, gene therapy

Creative problem solver

Ability to operate in a fast-paced, multi-disciplinary industrial environment

Education and Skills

• A minimum PhD or equivalent, in bioprocessing, biological sciences, gene therapy