Orchard Therapeutics

Lead and continuously improve global safety operations processes, including case intake, processing, and submissions, ensuring alignment with global PV regulations and company policies with close oversight of the...

· Conduct microbiology workflows for preparation of plasmids stocks and libraries.

· Team building: Build and lead a high-performing Biostatistics team, promote collaboration and advance professional development. Develop and monitor departmental objectives. Ensure adherence to annual budget targets,...

· Strategic input: Collaborate with clinical, regulatory and medical affairs colleagues to develop and implement a strategy for clinical development. · Regulatory engagement: Contribute to regulatory briefing documents,...

Maintain a strong financial reporting and control environment. · Lead the month-end close process ensuring accuracy, timeliness and completeness of financial results. Activities include performing detailed account...

Assist in the development, implementation and continuous improvement of the company’s Health & Safety Management System. · Champion compliance with relevant legislation including the Health and Safety at Work Act 1974...

· Assist in the preparation of monthly financial reporting to parent company.

Monitor and troubleshoot any issues that arise, ensuring the smooth operation of the ELN platform. · Write technical documentation to support ELN usage. · Deliver ELN training as required.

The role is accountable for the Quality strategy across these areas and works cross-functionally with Facilities, Engineering, Validation, Operations, MSAT, QC and Quality Compliance to ensure the site is designed,...

This role will report to the Senior Director, Regulatory Science. The successful candidate will have the opportunity to primarily work with Global and Regional Regulatory Leads who are responsible for the post-approval...

The Director, Pharmacovigilance is a safety expert with medical/scientific knowledge on the safety and benefit-risk profile of one or more Orchard products that can be in the investigational and / or marketed phase of...

Oversee the process for planning and implementation of the Global Medical Communications strategy across assigned investigational and approved gene therapy programs in alignment with program and organizational goals ·...

GMP Manufacturing Suite - Design, Build & Commissioning • Lead end-to-end design and construction of the clinical GMP gene therapy manufacturing suite, acting as the primary internal owner and technical authority...

Bachelor’s degree in Life Sciences required. · Advanced degree (MS, PhD, or equivalent) preferred. · Substantial experience leading Clinical Operations and Data Management teams.

· Lead and manage clinical study/studies according to global regulatory requirements (including but not limited to US CFR, EU CTD/CTR, and ICH GCP) and Orchard SOPs. · Collaborate with cross functional study team(s),...

The Senior Research Technician will be responsible for oversight and management of technical activities relating to core lentiviral vector production and cell & gene therapy analytical methods for the Department of...