Technical Specialist - Downstream
PE Global are currently recruiting for a Technical Services Specialist - Downstream for a client site in Athlone - Position Summary. Responsible for providing technology transfer activities for the cGMP Biologics processes at clients facility in Athlone. The position will provide downstream processing expertise to support the facility design, start-up and routine commercial manufacturing. The Technical Services scientist will be responsible for supporting technology transfer of new or existing drug substance manufacturing processes to the facility, and will be required to work in close collaboration with Process Development, Engineering, Validation, Supply Chain, Quality, Regulatory and other involved departments to ensure successful facility design, construction, startup and qualification. The position is accountable for timely completion of technical transfer related milestones, will support technical transfer activities from planning to completion including the oversight of downstream unit operations and will address complex technical problems arising during the technical transfer. Responsibilities also include review and approval of CMC sections for regulatory filing documents and responses to regulatory questions. Principal Responsibilities. To provide process expertise in the area of buffer preparation and downstream processing / purification to support client side design team in its efforts associated with the Athlone Biologics facility. To participate in cross functional downstream design teams as required in support of overall design goals and expectations. To lead and support process risk assessments where required. To author and review process transfer documentation, gap assessments, technical reports, process validation documents, and portions of regulatory submissions. To identify requirements for laboratory studies to support facility design decisions or process transfer, and to liaise closely with Process Development to oversee the design and execution of studies. To provide technical oversight of routine process monitoring and follow-up on any significant adverse trends. To identify and implement process improvements; e.g. yield, cycle time reduction. To oversee the execution of technical studies and validation protocols on the manufacturing floor. Temporary shift working may be required during periods of engineering batch and validation batch execution. To lead manufacturing floor support for troubleshooting and investigations into downstream processes and provide general technical oversight of process. To author and review IND, BLA and other technical documents for regulatory agency submissions. Qualifications. Minimum 3/4 years’ experience in Technical Services / Process Development / Manufacturing Support in a biological bulk drug substance manufacturing organization. Technical and operational knowledge of multiple unit operations in downstream processing, including buffer preparation, chromatography, ultrafiltration / diafiltration and membrane filtration. Strong understanding of technology transfer, scale-up and process validation. Comprehensive understanding of cGMP requirements for commercial biopharmaceutical manufacturing and the ability to implement best practices to ensure multi-product bulk drug manufacturing operations are cGMP compliant. Ability to present and defend technical and scientific approaches in both written and verbal form. Experience of authoring CMC sections of regulatory submissions would be an advantage. Ability to influence others without direct authority and communicate with all levels of the organization. Ability to drive for results independently and adapt to rapidly changing priorities. Experience of Validation / Verification of GMP equipment or processes would be beneficial. Experience of design, commissioning and start-up of a bulk drug substance facility would be beneficial. Education. Minimum requirement B.Sc in Biochemistry, Biology, Chemistry, Biotechnology or equivalent, or B.Eng. Process or Chemical Engineering. A higher degree (M.Sc. or Ph.D.) would be an advantage. Interested Candidates should send their CV to Audrey.firstname.lastname@example.org or call 0214297900. This job originally appeared on RecruitIreland.com.
372 days ago