We are looking for a Process Validation scientist to join the Cell and Gene Therapy Technology Department to support development, GMP manufacture and commercialization of gene therapy products.
This will include oversight of vector unit operations (upstream and downstream) and cell therapy of autologous products using stem cells.
This role requires someone with good knowledge of Process Validation activities, who is keen to establish procedures in-house at Orchard Therapeutics.
The applicant should have a good knowledge of vector manufacture, cell and gene therapy or biopharmaceutical manufacture.
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.
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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
Author / review of technical documents related to Health Authority submissions, PPQ deliverables, deviations, Tech transfer and process monitoring
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 with manufacturing or process development within the pharmaceutical or biopharma industry, preferably in vector, 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 process validation activities
Ability to evaluate and interpret development and manufacturing 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
Knowledge of vector and cell therapy processes, or with Biologics processes would be advantageous
Degree or equivalent higher education qualifications in a relevant science or engineering discipline.
Extensive experience in the biopharmaceutical industry leading process validation activities or process development
Orchard Therapeutics is an Equal Opportunity employer.
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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.