Purpose The Technical Services team are process subject matter experts and provide technical support to projects and a variety of complex issues that arise in manufacturing.
The Material Specialist 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.
They will gather and analyze data, draw conclusions, and make recommendations to the broader Technical Services team.
The Material Specialist will also support major projects with report writing, presenting process data, managing project schedules and communicating progress to the wider team.
Responsibilities Serve as subject matter expert (SME) on new material introduction (NMI) or the BDS facility Responsible for technical leadership and managing the introduction of new / second sourcing of raw materials / consumables to the ADMF facility including generation of material lists, Bill of Materials 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 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 Requirements BSc of MSc in 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 Good interpersonal skills coupled with demonstrated ability to effectively work in a matrix organization and in local group settings Ability to present and defend technical and scientific approaches in both written and verbal form Ability to drive for results independently and adapt to rapidly changing priorities Detail orientated Technical writing competency Skills: Technical Writing New Material Introduction Biologics
