Senior Scientist, Manufacturing Science and Technologies (Fixed Term 12-months)

Location: London

Reporting to: Associate Director, MSAT (Cell Process)

Job Summary

The successful candidate will be providing maternity cover for 12 months fixed term with responsibility for overseeing characterization and validation activities to support transition of validated assets from Technical Development to MSAT and ensure readiness of late phase programs for commercialization along with overseeing GMP manufacture at CDMO. The individual will have relevant experience in Cell Gene therapy products, GMP manufacture particularly in cell therapies. The post-holder will be a key member of the MSAT team and provide phase appropriate management of cell DS DP processes in-line with program and company plans and will work collaboratively with both internal and external stakeholders to ensure timely and robust implementation of appropriate product quality attribute strategies as well as represent Orchard in regulatory inspections and discussions.

Key Elements and Responsibilities

• Support clinical GMP production and testing of Drug Substance (DS) and Drug product (DP) product at CDMOs including but not limited to review and approval of master & executed batch records, test records and associated documentation for DP manufacture & release.
• Provide expert compilation, review, editing and approval of relevant documentation including but not limited to master production records, standard operating procedures, development/validation protocols and reports & quality documentation.
• Support technology transfer of PPQ-DS/DP process manufacture to GMP or throughout GMP facilities as required.
• Collect, assemble, analyze and summarize production data from early-stage trials using appropriate statistical methods and ensure phase appropriate monitoring of DP manufacturing data to support process control parameters and specifications and participate in OOS and OOT investigations according to internal SOPs.
• Oversee the development of early-stage control strategy and defining process characterization studies during clinical manufacture up to PPQ and lead post PPQ activities and product management.
• Maintain a high Quality standard by complying with all SOPs related to GxP, trainings, data integrity, participation in quality investigations and ensuring timely resolution of all manufacturing quality events.
• Establish process validation procedures and templates to standardize approaches to preparation, execution and reporting of activities.
• Oversee development validation activities and ensure requirements pre PPQ, in accordance with current industry standards, CMC regulatory standards and best practices in the evolving field of cell and gene therapy.
• Lead & participate in multi-disciplinary teams to perform risk-based analysis of processes where appropriate and providing impact assessments as required.
• Assess the impact of process changes on validation status and support change implementation.
• Author/ review of technical documents and relevant sections related to Health Authority submissions.
• Participate in relevant internal and external meetings as required and communicate complex information to various audiences.
• Travel as required to provide on-site support oversight during key DS/DP manufacturing activities & provide support to CDMOs.

Required knowledge

• 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 and understanding of technology transfer.
• Experience within other aspects of Process Validation.
• Experience in 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 to clearly 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.

Education

• 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.