Scientist, QC Technical Transfer Lead

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BMS Cruiserath Biologics is seeking to recruit a Scientist, Technical Transfer Lead for the QC Shared Services Team. Reporting to the AD QC Shared Services, the technical transfer lead will be responsible for supporting insourcing of new products into laboratories as per agreed timelines to support the Cruiserath Biologics SDP and MPCC manufacturing schedule or support of testing for products manufactured within the BMS network.

Project management and co-ordination of QC technical transfers for new products to the QC laboratories, inclusive or raw material, cleaning validation, in process, DS and DP methods for SDP, GBL and MPCC. Ownership of QC change controls for new product introductions. Maintain oversight of all ongoing transfers to the QC department and ensure adherence to agreed timelines. Provide escalations where required and facilitate/drive resolution across relevant teams. Definition of Transfer Strategy for new products to the QC laboratories. Support resource management for tech transfer insourcing across QC teams. Point of Contact for QC Technical Transfer at cross-functional meetings. Ensure Laboratory Readiness across QC departments to support testing. Support tech transfer standardisation and process improvements as required. Compliance with Standard Operating Procedures and Registered Specifications. Ensure the laboratory is operated in a safe manner and a Safety culture is embedded within the team. Keeps abreast of current corporate and industry requirements and compliance trends as they pertain to laboratory operations and aseptic manufacturing. Approval of SOPs, trend data, non-conformances, Transfer plans, validation protocols, reports, method verifications and equipment qualifications where required. Participate in regulatory agency inspections as required. Strategically plan and implement procedures and systems to maximise operating efficiency through the use of Operational Excellence tools. Qualifications, Knowledge and Skills Required: A minimum of a B.Sc. in Biochemistry or related discipline and must have at least 5 years’ experience, in a GMP laboratory setting with QC testing. Understanding of the needs and best practices of routine biopharmaceutical drug product and drug substance laboratories is desirable, strong background in and aseptic manufacturing is an advantage. Demonstrate leadership ability and flexibility along with good communication and teamwork skills. Excellent communication skills are critical. Ability to communicate on a global level is required, in addition to meeting management skills. Excellent organisational and planning skills. Demonstrated experience in corporate and regulatory audits Why you should apply You will help patients in their fight against serious diseases You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees. You’ll get a competitive salary and a great benefits package including an annual bonus, pension contribution, family medical