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 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 startup and process
qualification. The position is
accountable for timely completion of technical transfer related milestones,
with particular emphasis on new product introduction, Process Owner for cell
culture unit operations, Process Validation (PPQ), Process Monitoring, Risk
Assessment (using QRM tools), and building strategies / SME capability.
- To provide process expertise in the following
- Downstream: to include buffer preparation,
purification and viral reduction steps including chromatography,
ultrafiltration viral reduction filtration and viral inactivation technologies
and DS formulation and bulk fill.
- To author and review process transfer
documentation, gap assessments, technical protocols and reports, and process
validation documentation, strategy documents.
- 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
- 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
- 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
- Minimum 2+ years’ experience in Technical
Services / Process Development / Manufacturing in a biological bulk drug
substance manufacturing organization
- Technical and operational knowledge of multiple
unit operations in cell culture 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
- 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
- Knowledge or experience of start-up or systems
would be ideal.
- Detail orientated.
- Technical writing competency
- B.Sc. in Biochemistry, Biology, Chemistry or
equivalent, or B.Eng. Process or Chemical Engineering
- Sc. or other postgraduate qualification in
Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical
- Experience of authoring CMC sections of