We are looking for a Process Validation scientist / engineer to join the Cell and Gene Therapy Technology Department to support commercialization of gene therapy products. This role requires someone with good knowledge of Process Validation activities, who is keen to establish procedures in-house at Orchard Therapeutics. This will include use of risk-based procedures using appropriate tools to evaluate all aspects of the manufacturing process and product. You will work with cross functional teams and with CMOs to generate documentation to support process validation activities as well as support of Regulatory questions and Health Authority Inspections. In addition, support of transport validation will be required within this role, to ensure efficient and compliant procedures are established between manufacturing sites and qualified treatment centres.
Key Elements and Responsibilities
Establish process validation procedures and templates to standardize approaches to preparation, execution and reporting of activities
Lead / participate in multi-disciplinary teams to perform risk-based analysis of processes
Identify validation requirements, incorporating industry standards and best practices in the evolving field of cell and gene therapy
Write and execute process validation documentation, including validation master plans, protocols, reports and change controls
Assess process changes on validation status
Support transport validation risk assessment and gap analysis of current and new routes
Support shipping validation studies in conjunction with CMOs and contract labs to ensure that products are shipped with compliant, efficient and cost-effective solutions
Understanding of the Product Life Cycle, with reference to industry standards and guidelines
Experience with risk-based approaches, such as Failure Modes and Effects Analysis
Experience within the pharmaceutical or biopharma industry, preferably in cell and gene therapy.
Experience within a Process Validation role.
Experience within other aspects of Process Validation.
Understanding of GMP manufacture, process development and process characterization
Skills & Abilities
Demonstrated skills and capability in planning, preparing, executing and reporting of validation activities
Ability to evaluate and interpret data
Knowledge of statistical data analysis
Attention to detail
Working across cross functional teams to direct validation activities and drive results
Ability to visualize / present data in order to communicate ideas, concepts and results to technical and non-technical audiences
Interest in continuous improvement of processes
Organization and time management to deliver results
Degree or equivalent higher education qualifications in a relevant science or engineering discipline.
Extensive experience in the biopharmaceutical industry leading process validation activities
Orchard Therapeutics is an Equal Opportunity employer.
Notice to All Applicants: Orchard Therapeutics participates in E-Verify
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.