Job Description
This is a rare opportunity to join a young, exciting high achieving clinical-stage biotechnology company.
Our client is a clinical-stage neuroscience company focused on the discovery and development of novel therapies with the potential to fundamentally change the course of progressive, life-threatening diseases The position provides excellent opportunity for the right candidate as the role requires the use of strong management, technical & analytical skills along with general quality/current Good Manufacturing Practice (cGMP) expertise within an exciting biotech environment, that is focused on late-stage clinical trial and pre-approval inspection readiness towards commercial production.
Job Spec
This position will provide day-to-day Quality and technical leadership and support to the CMC operations team as well as to the contract manufacturing sites (CDMOs) in support of product manufacturing, release testing and stability studies for global clinical supply chain.
Responsibilities:
- Provide quality/compliance support to the Technical Operations teams in the progression of existing programs, new product introduction, technical transfers, supplier selection, validation and CDMO monitoring.
- Author and/or critically 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.
- Actively manage the processes for quality events involving CDMOs such as major investigations, change management, analytical investigations, stability investigations, product complaints and ensure risks and trends are evaluated and managed.
- Ensure IMP batch GMP manufacturing / clinical supply program continuity through batch documentation review, QC/stability program oversight, product lifecycle disposition, and clinical supply maintenance/
- Partner with Operational & Quality teams to develop quality system processes that will ensure compliance to GxP requirements and are aligned with program life cycle stages.
- Review/approve analytical procedures or specifications impacting the identity, strength, quality, and purity of the components, in-process materials, and final product.
- Manage and continually develop the stability procedures and data system for intermediates and final product stability programs. Write or critically review stability reports as necessary to establish product shelf-life ensuring real time trending and monitoring against established specifications.
- Provide the requisite quality support to functional groups such as Regulatory/CMC and in support of regulatory filings, regulatory agency questions.
- Support the external auditing program by participation in audits of Third Parties as requested.
- Other duties as assigned.
- Travel 10-15 % as requested.
Person Spec
Education and Experience:
- Bachelor’s degree in a health science, medical field or equivalent. Postgraduate qualification(s) would be desirable.
- 8 + years of experience in the pharmaceutical or biotechnology industry with knowledge of different parenteral product configurations and new product introductions.
- 5 + years of experience within Quality (+4 years managing quality functions/ teams), with strong knowledge and understanding of applicable legislation, regulations, and guidelines,
- Laboratories expertise and good knowledge of current analytical and laboratory practices including understanding of pharmacopeial requirements, e.g., USP/EP and of stability program. management including data processing. QP qualification, previous experience in manufacturing, laboratories, with biopharmaceuticals or combination products preferred.
- Demonstrated leadership ability to drive results that are needed to achieve the company objectives in accord with company core cultural values of courageous, imaginative, selfless, and joyful.
- Hands-on approach with good decision-making aptitude.
- Excellent verbal and written communication skills.
- Strong organizational skills, and ability to support and prioritize multiple complex projects.
Cv to gerry@rftgroup.ieRFT, Maple House, South County Business Park, Leopardstown, Dublin D18 F863