Job Description
Tech Services Material Specialist Summary: Our client, a biopharmaceutical company based in West Dublin, is seeking a Technical Services Material Specialist. The successful candidate will work alongside Quality, Technical and QC to execute tasks associated with introduction and qualification of new raw materials for existing and new products including associated deviations or changes to approved processes. The incumbent will gather and analyse data, draw conclusions, and make recommendations to the broader Technical Services team. Responsibilities: Serve as subject matter expert (SME) on new material introduction (NMI) for the BDS facility. Responsible for technical leadership and managing the introduction of new / second sourcing of raw materials / consumables to our clients facility including generation of material lists, Bill of Materials (BoM) and technical risk assessments. Manage supplier change notifications within the team and lead key material process changes using change control system. Partner and support Technical Services teams in daily activities on Upstream and Downstream Materials work fronts. Participate in investigation teams, and support raw material change requests for vendors. Gather, analyse and maintain process data. Support major projects with report writing, presenting process data, managing project schedules and communicating progress to the wider team. Work closely with Quality, Supply Chain and Manufacturing Operations to ensure availability and release of materials in line with technology transfer / commercial schedules. Serve as SME for NMI during regulatory inspection. Qualifications & Experience: B.Sc. or M.Sc. in Biotechnology, Biological Sciences, Biochemistry, Bioengineering or a similar scientific discipline. Minimum 4+ years experience in Technical Services / Process Development / Manufacturing in a biological bulk drug substance manufacturing organization. Technical and operational knowledge of upstream and downstream pharmaceutical processes, quality systems and regulatory requirements across multiple health authorities. Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing. Technical writing competency. . Skills: Planning Drub Production Pharmaceutical Manufacturing