Overview
The Technical Services Specialist has primary responsibility in supporting the cGMP manufacture of biological bulk drug substance (BDS).
The Technical Specialist will provide processing expertise to support the technology transfer, process validation and routine commercial manufacturing for Upstream and/or Downstream manufacturing.
The Technical Specialist will be responsible for providing support for technology transfer of new/existing drug substance (DS) manufacturing processes to the Dublin facility, and will be required to work in close collaboration with Process Development, DS Process Sending unit, Operations, Engineering, Supply Chain, Quality, Quality Control, Regulatory and other involved departments to ensure successful facility start-up, clinical manufacture and process qualification.
The position is accountable for timely completion of technical transfer related milestones, with particular emphasis on new product introduction, clinical manufacturing, process validation, process monitoring, risk assessment (using Quality Risk Management tools), and building strategies / SME capability.
Responsibilities
To provide process expertise in one, or both of the following disciplines:
Upstream (Cell culture focus) to include media preparation, large scale cell culture bulk drug substance manufacturing process (vial thaw, scale up, seed reactors and production bioreactors and harvest centrifugation/clarification).
Downstream to include buffer preparation, purification and viral reduction steps including chromatography, ultrafiltration, viral reduction filtration and viral inactivation technologies and DS formulation, bulk fill and storage.
To author and review process transfer documentation, gap assessments, technical protocols and reports, clinical manufacturing documentation, process validation documentation, strategy documents etc.
To identify requirements for laboratory studies to support process fit, decisions or process transfer, and to liaise closely with Global Process Development to oversee the design and execution of studies.
To support the introduction of new raw materials and consumables through the generation of materials lists, Bills of Materials, material specifications and outline testing requirements.
To work closely with colleagues in Quality, Supply Chain and Manufacturing Operations to ensure availability and release of materials to meet technology transfer and routine manufacturing timelines.
To identify and implement process improvements, e.g. yield, cycle time reduction.
To generate documentation protocols and lead the execution of plant supporting studies and technical studies on the manufacturing floor at commercial scale.
May be required to work periodically out of normal business hours (temporary shift working) during periods of engineering and validation batch execution and provide on-call support to manufacturing.
To provide on the floor support for troubleshooting processing issues and to lead manufacturing investigations into process deviations and resolution.
Lead any key process changes using change control system.
Adherence to highest standards for Compliance (Quality and Safety), implement corporate standards and liaise effectively with global groups and provide technical support during audits.
Ensure compliance with site EHS policy, cGMP and other business regulations and participate in risk assessments, audits, and incident investigations.
To author and review common technical document (CTD) sections and reports for regulatory agency submissions.
To serve as a subject-matter expert (SME) on technology transfer and process support during regulatory agency inspections.
Qualifications
Minimum 3+ years' experience in Technical Services / Process Development/Manufacturing Support in a biological bulk drug substance manufacturing organisation
Technical and operational knowledge of multiple unit operations in cell culture and or downstream purification processing
Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing
Good interpersonal skills coupled with demonstrated ability to effectively work in a matrix organization, and in local group settings
Ability to present and defend technical and scientific approaches in both written and verbal form
Ability to drive for results independently and adapt to rapidly changing priorities
Experience of Technology Transfer activities is advantageous
Experience of clinical manufacturing activities is advantageous
Knowledge or experience of start-up or systems would be ideal
Detail orientated
Technical writing competency
Education
B.Sc.
in Biochemistry, Biology, Chemistry or equivalent, or B.Eng.
Process or Chemical Engineering
M.Sc.
or other postgraduate qualification in Biochemistry, Biology, Chemistry or equivalent, or B.Eng.
Process or Chemical Engineering.
Experience of authoring CMC sections of regulatory submissions
#J-*****-Ljbffr