KPC International - Excellence from Concept to CompletionKPC International began operations in 2001, our team of Engineers and Scientists have helped our clients achieve project success all over the world within the pharmaceutical and biopharmaceutical space.We specialise in Plant Facility Start-Up from Strategy and Planning to Execution, through to Operational Readiness. We are proud to support our clients in delivering their life changing products to patients.Seeking an experienced professional to provide process expertise in Upstream (cell culture) and/or Downstream purification within bulk drug substance manufacturing.Key Responsibilities:Provide technical support across upstream (media prep, scale-up, bioreactors, harvest) and/or downstream (buffers, chromatography, UF/DF, viral reduction, formulation, bulk fill).Author and review process transfer documentation, validation protocols, technical reports, and regulatory (CTD/CMC) submissions.Lead technology transfer activities and support clinical and commercial manufacturing.Drive process improvements (yield, cycle time, robustness).Support material introduction, BOM generation, and cross-functional coordination with Quality, Supply Chain, and Operations.Lead deviation investigations, change controls, and provide on-floor troubleshooting support.Ensure full compliance with cGMP, EHS, and regulatory standards.Act as SME during audits and regulatory inspections.Experience Required:3+ years in Technical Services, Process Development, or Manufacturing Support within biologics.Strong knowledge of upstream and/or downstream unit operations.Solid understanding of cGMP and regulatory requirements.Technology transfer and clinical manufacturing experience advantageous.Strong technical writing, communication, and problem-solving skills.Education:BSc/MSc in Biochemistry, Biology, Chemistry, or BEng in Process/Chemical Engineering.Experience authoring CMC sections for regulatory submissions desirable.KPC -International offers an inclusive environment where you can broaden your experience, perspective and skills to help make an impact on the lives of others.KPC – International is an Equal Opportunity Employer.#LI-BC1