Msat Specialist

Careerwise Recruitment

Limerick

MANUFACTURING, SCIENCE AND TECHNOLOGY SPECIALIST with 3 years of related experience in a cGMP environment or MS with 1 year experience, required by CareerWise Recruitment for our BioTech client in Limerick. The MANUFACTURING, SCIENCE AND TECHNOLOGY SPECIALIST will provide technical support for internal and external technology transfer of biopharmaceutical drug substance manufacturing processes for monoclonal antibodies/therapeutic proteins and provide post transfer support. THE ROLE: * Assess manufacturing requirements and capabilities prior to the transfer of new processes into the manufacturing facilities; generate facility fit assessments and high level gap assessments. * Generate and review documentation supporting technology transfer (e.g., master plans and reports, process descriptions, memos, detailed gap assessments, as appropriate. * Generate options to resolve technical challenges and present them for endorsement. * As a person in plant, provide technical support and training of manufacturing personnel to improve understanding of both cell culture and purification operations across the sites. * Gather, trend, and analyze process generated data; summarize findings in memos and reports and presentations. * Perform review of manufacturing documentation generated by the receiving unit (manufacturing records, batch sheets, changeover protocols, SOPs, etc.). * Participate in study teams and investigations (internal and external. * Work effectively and efficiently in a team-oriented environment to ensure maximum and high-quality output. * Monitor and prioritize processes and troubleshoot technical difficulties as needed. * Ensures all tasks are performed in a manner consistent with safety standards and within cGMP guidelines. * Help to build process knowledge base, controls for technology transfer and knowledge management and lessons learned database; identify continuous improvement activities to improve performance. * Travel may be required in support of tech transfer activities. REQUIREMENTS: * Manufacturing Sciences and Technology Specialist requires BS/BA in a scientific discipline or engineering with 3 years of related experience in a cGMP environment, or MS with 1 year experience; * Process development or production experience preferred. Please call Conor Twomey today for further information on 021 4297422 or email: ctwomey@careerwise.ie. CareerWise Recruitment (In Search of Excellence. Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent. This job originally appeared on RecruitIreland.com.

2111 days ago