Orchard Therapeutics is hiring an

Associate Director, Early Stage Cell Therapy Operations

London, United Kingdom

Orchard Therapeutics, Ltd. is a biotechnology company incorporated in September 2015 and dedicated to bringing transformative gene therapies to patients with serious and life-threatening rare diseases. This an exciting opportunity for a well-qualified candidate to join a rapidly growing international company focused on transforming the lives of patients through innovative gene therapies.

The Associate Director, Early-stage Cell Therapy Operations will oversee and coordinate the development, manufacture and delivery of Orchard Therapeutics innovative gene-modified cell-based therapeutic products in cooperation with a series of academic and CMO collaborators. The role will be focused on bringing commercial company expertise and support to a significant and wide-ranging academic collaboration from pre-clinical development to early clinical work.

Such activities will include process and assay development, cell therapy intermediate and drug product formulation and stability evaluation, raw material evaluation, process scale-up / scale-out, and validation of manufacturing processes and controls to support company’s product programs and alliances from pre-clinical research through to early-stage clinical trials.

This role is ideal for an experienced professional who is looking to work in a small team with high-level academic collaborators at the top of their field, whilst also working and engaging with the large and highly experienced commercial and clinical-stage CMC team at Orchard. The role may suit someone with cell therapy operations experience gained either in an academic GMP setting, a CMO or clinical-stage cell therapy company.

Requirements

Responsibilities

  • Coordinate and oversee the development, scale-up and optimization testing of cell isolation, cell culture, cell transduction and cell cryo-preservation processes to include:
  • Process and assay development, cell therapy, drug product formulation and stability evaluation, raw material evaluation, process scale-up / scale-out, and validation of manufacturing processes and controls
  • Contribute to the compilation and review of master production records, standard operating procedures, development/validation protocols and reports
  • Provide technical support for batch record review and associated documentation for release of gene-modified cell therapy products.
  • Support investigators for release of gene-modified cell therapy products as required
  • Participate in cross-functional activities with research, pre-clinical development, QA, QC, clinical development and commercial departments to ensure the successful achievement of company timelines and milestones
  • Prepare protocols and reports for prospective qualification and validation activities
  • Ensure the successful execution of activities performed between departments and company designated collaborators and CMO’s
  • Provide data summaries for CMC / CTD documents for regulatory filings with US and EU regulatory agencies

Job requirements

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

  • Solid experience in the biotechnology or pharma industry with a primary focus on the development, manufacture, distribution and delivery of cell and gene-based therapy products
  • In-depth technical experience with a proven track record of developing, integrating and implementing equipment and platforms for closed system:
  • Cell isolation/purification, culture, transduction and washing/volume reduction
  • Formulation and final fill of cell-based products
  • Proven experience of the set-up, technology transfer and validation of manufacturing processes at CMOs
  • In-depth knowledge of FDA, EMA, GMP and ICH regulatory requirements
  • DOE, PAT and QBD experience a plus
  • This position requires frequent on-site presence at CMOs and contract vendors. Therefore, ability to travel is a pre-requisite

Education and skills

  • Minimum BSc or equivalent in bioprocessing, chemical engineering, or biological sciences
  • Experience of managing CMO relationships and projects
  • Experience of working with academic partners
  • Working knowledge of US and European regulatory requirements
  • Excellent interpersonal skills
  • Outstanding organizational skills
  • Excellent written and oral communication skills
  • Ability to operate in a fast-paced, multi-disciplinary industrial environment

RECRUITERS

All employment offers and CV’s are managed through our Human Resources Department and all candidates are presented through this avenue. Therefore, the Human Resources Department at Orchard Therapeutics requests that recruiters are not to contact Orchard Therapeutics employees directly to present candidates. Complying with this request will be a factor in determining future professional relationships with Orchard Therapeutics.  Orchard Therapeutics will not accept unsolicited resumes from any source other than directly from candidates for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the recruiter does not create any implied obligation on the part of Orchard Therapeutics.

Benefits

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