Job Description
CMC Manager
Our client is an exciting, rapid growing publicly listed clinical stage biopharmaceutical business focussed on establishing best in class teams across all its functions. In 2021, the company successfully completed an IPO on the Nasdaq. To date, the company has raised $300 million +, and is engaged in a major expansion of its team in Ireland. The CMC Manager will lead projects from the technical feasibility evaluation through commercial registration of the company drug product portfolio. The preferred candidate will have experience of drug development, including drug substance development and the accompanying analysis as well as strong vendor management.
This role can be hybrid or remote within in Ireland, Europe or the UK.
Job Spec
· Contribute to the strategy for development and clinical study production of company drug products and drug substance in alignment with company goals and clinical plans.
· Oversee CMC related activities with vendors and internally: build out and implement a control strategy build; PPQ.
· Ensure all DS and DP-related processes are in line with health, safety, environmental and quality requirements including regulations, policies, applicable guidelines and procedures.
· Review l analytical data, development reports and protocols, work orders and quotes related to CMC.
· Summarize and present CMC, development plans, activities and outputs to management or other departments.
· Contribute and review CMC related regulatory documents such as product development reports for regulatory filings.
· Management of CMOs, scientific advisors, regulatory advisors as needed to achieve CMC goals.
· Assisting in defining supply strategies for DS and DP required for clinical trials and product launch.
· Manage drug substance and clinical supply including raising shipments and updating inventory, experience with controlled drug would be desirable.
· Liaise with other CMC functions including Drug Product, Analytical and Engineering/Device to provide technical support in establishment of specifications and analytical methodology.
· Provide data interpretation and perform data trending and monitoring using statistical methods as appropriate.
· Support the identification and selection of suitable development and commercial manufacturing vendors (CMOs).
· Assisting in coordinating the assembly of regulatory packages, both towards FDA and EMA.
Person Spec
· Minimum 8 years’ experience in drug substance, drug product, or project management in a CMC function in a pharmaceutical and/or biotech company or CRO.
· Experience on authoring and reviewing CMC documentation.
· Experience in Drug product development from early to late stage inclusive of GMP/clinical supply manufacture.
· Experience with regulatory documentation for CMC activities on drug substance, drug product both towards FDA and EMA is mandatory.
· Solid experience with working in a regulated environment under GxP and with adherence to Company SOPs, policies and guidelines.
· Updated knowledge of ICH GMP is required.
· Excellent communication, presentation, and interpersonal skills.
· Self-driven and motivated team player.
· Familiar with working in a virtual set-up.
· Fluent in written and spoken professional English.
CV’s to Laurentina Kennedy at The RFT Group /laurentina@rftgroup/ 01 2302400.