Senior Pharmaceutical Scientist

Just Life Sciences are seeking a Pharmaceutical Senior Scientist, who will lead a small team of scientists and manage multiple complex pharmaceutical development, transfer and scale up projects. To provide technical expertise in pharmaceutical development, transfer and scale up over a range of dosage forms. To be client focused and deliver projects to agreed timelines and milestones. Duties · Lead multiple complex pharmaceutical development, technical transfer and scale up projects. · Able to act as SME for assigned process/projects to support all internal and external needs, including client visits and regulatory audits. · Responsible for generation of various gap analysis e.g. excipient, process, equipment, training to support efficient and effective on-boarding of NPI manufacturing process. · Responsible for the generation of technical protocols to allow generation of required batch documentation by Associate Process Scientist. Generation of DOE protocols to support development activities · Responsible for the reviewing and generation of manufacturing batch records for development, technical transfer, scale up and validation in accordance with cGMP practices. Ensure batch documentation is available to agreed SLA. · Responsible for the analysis and interpretation of complex data sets e.g. DOE results using statistical tools including JMP, Minitab and Design Expert. · Responsible for the generation of Development, Transfer and Scale up manufacturing reports within agreed SLA to support achievement of project milestones. · Ensure up to date engineering solutions and technologies are employed when working on new projects · Advise and support CAPEX and/or improvement activities in the manufacturing area required to support client projects. · Lead Complex deviation investigations using RCA tools to determine Root cause and support CAPA implementation. · Liaise with all functions to ensure that production schedules are adhered to 100% of the time where this is possible. · To communicate effectively with internal and external customers and participate with them in problem solving and continuous improvement activities · Responsible for progressing and assisting in the technical aspects of manufacturing process validation exercises, including the generation of QRM/FMEA and identification of CQAs, CPPs and Drug Product CQAs · To conduct necessary briefings and training of manufacturing personnel where required, promoting best practices for development batch manufacture, technical transfer and scale up. (E.g. ICH/ISPE) · To manage performance of direct reports and process all HR and departmental documentation including; sickness related documents, absence request forms, staff appraisals including 1:1s, probationary reviews and PMRs, PDPs and disciplinary procedures in line with company requirements · To observe safe working practices in handling of materials and when conducting manual handling activities · To comply with Company Policies, including HSE and environmental standards for the handling of potent products down to OELs of 0.01µg/m3 · To identify self-development needs for future performance and those of direct reports, implement through PDP. · To undertake such tasks and to manage specific internal or ad hoc projects as and when required to meet department and business needs and within the scope of the job-holder’s capabilities and responsibilities Create and sustain a working environment that promotes the Group's Services Values and Behaviours. Experience · Degree in a suitable scientific discipline (e.g. chemistry, microbiology, engineering) · Higher Degree in a suitable scientific discipline (e.g. chemistry, pharmacy, microbiology, engineering) or equivalent experience. Experience: · Extensive experience in Pharmaceutical development and manufacturing processing environment, ideally in OSD, Potent molecules and other dosage forms. Technical transfer and scale up of manufacturing process including process validation experience/support If of interest please email your CV to justyn at justlifesciences dot com This job was originally posted as www.totaljobs.com/job/89625460