Process Development Associate, Cell Therapy Operations - CTO2


Full-time

Menlo Park, California, United States

Cell Therapy Operations

Location: Menlo Park

Reporting to: Associate Director, Cell Therapy Operations


The Company:

Orchard Therapeutics is a leading global, fully integrated, commercial-stage biotech dedicated to transforming the lives of patients with rare diseases through innovative gene therapies.

Partnering with world-leading research institutions in gene therapy, Orchard’s portfolio of autologous ex vivo gene therapy programs has demonstrated sustained clinical benefit in over 150 patients across five disease areas. These programs include Strimvelis®, the first autologous ex vivo gene therapy approved by the EMA in 2016, 3 programs in advanced registrational studies in MLD (metachromatic leukodystrophy), WAS (Wiskott Aldrich syndrome) and ADA-SCID (adenosine deaminase severe combined immunodeficiency), 2 other clinical programs in X-CGD (X-linked chronic granulomatous disease) and beta-thalassemia, as well as an extensive preclinical pipeline


Orchard is a publicly traded company (NASDAQ: ORTX) with offices in the UK and the US, including London, San Francisco and Boston.

Job summary

The Cell Therapy Process Development Associate will perform processing and testing related to the development, manufacture and delivery of Orchard Therapeutics innovative gene-modified cell-based therapeutic products. Such activities will include cell isolation, cell therapy intermediate and final drug product formulation, raw material evaluation, and process scale-up / scale-out to support company’s product programs from pre-clinical research through to commercial. This role is ideal for a Development Associate that is looking to work in a small team, where a person’s contribution is valued. The team is going through an exciting growth phase, where everyone is fully involved in the development of the team dynamics. Activities include product-specific process development activities as well evaluation of platform changes for future implementation across programs.

Key Elements and Responsibilities

  • Carry out development, scale-up and optimization testing of cell isolation, cell culture, cell transduction and cell cryopreservation processes to include:
    • Cell isolation development, cell therapy intermediate and final drug product formulation, 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 protocols and reports
    • Provide technical support for batch record review and associated documentation for release of gene-modified cell therapy products. Support investigations 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
  • Other activities as may be assigned

Requirements

The ideal candidate for this position must have experience in the development, manufacture and delivery of cell-based therapy products with significant applied experience in the biotechnology industry.

Candidate must possess:

  • A minimum, BS or equivalent, in bioprocessing, medical technology, chemical engineering, or biological sciences.
  • Minimum of 2 years of experience in the biotechnology or pharma industry with a primary focus on the development, manufacture, distribution and delivery of cell-based therapy products
  • Experience preparing documentation for regulatory filings with US and EU regulatory agencies
  • Experience with the set-up and technology transfer of manufacturing processes and controls at CMOs
  • In-depth knowledge of FDA, EMA, GMP and ICH regulatory requirements
  • Proven personnel and project management skills
  • Outstanding organizational skills
  • Excellent written and oral communication skills
  • Ability to operate in a fast-paced, multi-disciplinary industrial environment
  • Experience of GMP cell processing facility commissioning, and production equipment design and validation, including IQ, OQ & PQ a plus

Skills & Abilities

  • Able to work in a dynamic environment
  • Excellent communication skills
  • Experience in statistical analysis
  • Physically able to perform laboratory duties such as pipetting, lifting materials weighing up to 6kg

Education

Bachelor degree in biology, chemistry or related field

Orchard Therapeutics is an Equal Opportunity, Affirmative Action employer. Minorities, women, veterans, and individuals with disabilities are encouraged to apply.

Benefits

The successful candidate will enjoy a competitive base salary and the opportunity to participate in incentive compensation programs, including a stock option plans. Orchard Therapeutics, Ltd. offers a comprehensive benefits program, including: medical, dental and vision care; paid vacation and holiday time; access to a voluntary 401(k). Orchard Therapeutics is an equal opportunity employer.


Notice to All Applicants: Orchard Therapeutics participates in E-Verify

For further information on this role do not hesitate to email HR@orchard-tx.com


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.