This innovator is a late stage clinical biotechnology company focused on the discovery, development and commercialisation of novel protein immunotherapies, for the potential treatment of diseases that involve amyloid or cell adhesion. With 3 product candidates at various stages of clinical trials, the future of this organisation is looking bright given recent trial results. Due to continued positive trial results, this organisation are looking to recruit a new QA/QC CMO Manager into the business that will be responsible for assisting in the set up of their Quality Operation here in Dublin.
Perform technical reviews from Quality perspective and ensure CMO’s compliance with manufacturing and testing procedures and specifications in support of release and stability testing.
Author and review Standard Operating Procedures (SOPs), batch records, and specification documents relating to the manufacture and testing procedures of starting materials, reference standards, drug substances, and drug products.
Prepare certificate of analysis for QA product release.
Review/Approve all analytical procedures or specifications impacting the identity, strength, quality, and purity of the components, in-process materials, and final product.
Write and review SOPs related to QC function.
Assist in preparation of CMC sections of regulatory submissions as requested.
Establish and implement stability program procedures for cell banks and final products. Write stability reports as necessary to establish product shelf-life.
Review and approve technical documentation, ensuring accuracy, clarity, and quality.
Review and evaluate all release and stability data to ensure compliance with established specifications for all aspects of the product.
Serve as technical lead for laboratory related investigations and provide support for process investigations as needed. Maintain compliance with cGMP regulations, and quickly resolve discrepancies.
Assist with validation activities, evaluating and trending of release and stability data, and assisting in any analytical/laboratory issues/investigations.
Maintain databases and documentation for tracking stability samples inventory and QC retains
Conduct and review supplier audits as requested
Bachelor’s degree in health science or medical field or equivalent.
8+ years of experience in the pharmaceutical or biotechnology industry.
Maintain up-to-date knowledge of current analytical and laboratory practices including a current understanding of USP/EP, cGMP regulations, ICH and FDA Guidance Documents.
To learn more apply on line or call Shane Browne on +353 1 6321865.