Are you a Bioprocess specialist with expertise in downstream technical processes? Then LSC have a an exciting role that would be right for you. Our multinational biotech client based in Ahtlone is looking for an experienced Downstream Technical Services Specialist to join and support their dynamic biotech design team of specialists.
The Technical Services Specialist you will:
o Participate in cross functional downstream design teams as required in support the overall design goals and expectations.
o Lead and support process risk assessments where required
o Author and review process transfer documentation, gap assessments, technical reports, process validation documents, and portions of regulatory submissions.
o 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.
o Provide technical oversight of routine process monitoring and follow-up on any significant adverse trends.
o Identify and implement process improvements; e.g. yield, cycle time reduction.
o To oversee the execution of technical studies and validation protocols on the manufacturing floor.
As a Technical Services Specialist you will have:
o Minimum requirement B.Sc in Biochemistry, Biology, Chemistry, Biotechnology or equivalent, or B.Eng. o Process or Chemical Engineering. A higher degree (M.Sc. or Ph.D.) would be an advantage
o Minimum 3/4 years’ experience in Technical Services / Process Development / Manufacturing Support in a biological bulk drug substance manufacturing organization.
o Technical and operational knowledge of multiple unit operations in downstream processing, including buffer preparation, chromatography, ultrafiltration / diafiltration and membrane filtration.
o 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.
For full details of this opportunity please contact Kathy Gillen on 021 4777329 or apply directly through this advert.