Engineering & Electronics
Technical Services Specialist
- Dublin North
PE Global is currently recruiting for a Technical Services Specialist on behalf of our client based in Dublin. This is an initial 18 month contract role.
The Technical Specialist has primary responsibility for providing scientific & technical support of (cell culture derived) drug substance manufacturing processes performed at ADMF, specifically the technology transfer of product(s) into ADMF. The successful candidate will be responsible for providing scientific and technical support through all phases of the product lifecycle, including technology transfer, process scale-up, process validation, routine manufacturing, and process/continual improvement programs. The position requires effective cross-functional collaboration with external contractors and internal partners including Manufacturing, Process Development, Engineering, Regulatory, QC and Quality to provide support of manufacturing of BDS.
- Provide process information and analysis to facilitate process/facility fit, and qualification of a large scale BDS facility through to NPI tech transfer startup, PPQ validation, in a multi-product BDS facility.
- Participate in Tech Transfer Receiving Unit activities, and provide technical guidance to team members in large scale cell culture/downstream purification processes, and provide SME support for the area on key audit topics.
- Provide scientific and technical input to facilitate decision making related to Tech Transfer.
- Develop/provide deep technical knowledge and understanding in cell culture processes; vial thaw, seed expansion, seed reactors and large scale production bioreactors, including centrifugation and depth filtration steps, or downstream purification processes; large scale column chromatography steps, ultrafiltration/diafiltration steps, pH adjustment, depth/nanofiltration steps, and final fill.
- Undertake technical risk assessments to support raw material assessment for NPI.
- Identify technical issues, and guide resolution of same.
- Provide SME knowledge and understanding in BDS manufacturing processes (upstream/downstream); cause and effect, scale up principles, QRM, and process validation strategies.
- Shape and develop strategy approaches for Technical Services in areas such as cell culture and downstream purification processes, technical studies supporting facility fit and regulatory filings, Technology Transfer, PPQ, CPV approach and so forth ensuring alignment to industry regulations, trends and advances.
- Ensure current with Regulatory changes, and industry trends, ensuring robust and scientifically sound rationale and justifications applied to Alexion manufacturing processes. Develop and shape standards and strategy documents to support BDS Manufacturing and Tech Transfer.
- Collaborate with Process Development and Engineering to influence the design and implementation of a robust process control strategy, complete process risk assessments and associated documentation to support equipment qualification activities, PPQ studies and key technical strategies.
- Engage with internal partners on pipeline processes for manufacturability.
- Be a QRM Risk facilitator/mentor for others, aligning approaches to risk assessment per Alexion procedures.
- Perform risk assessments to support the technology transfer e.g. pFMEA’s and other risk tools.
- Provide Technical input, review/approval into documentation associated with New Material Introduction, Manufacturing control and enterprises systems (MCS/MES) including manufacturing batch records, work instructions, competencies, and other related Technical documentation.
- Ongoing technical support of Manufacturing Operations by providing technical expertise for investigation and resolution of process deviations, CAPAs, review and approval of change controls.
- Short duration Person in Plant (PIP) observation may be required at sending units/existing facilities to support Tech Transfer into ADMF.
- Author, review and approval of reports which may support CMC sections for regulatory agency submissions and responses (as required).
- Contribute to successful regulatory agency inspections by providing subject-matter expertise on mammalian cell culture/downstream purification, technology transfer and manufacturing processes.
- Help develop first class technical/scientific staff to maintain a high level of current technical expertise within the Technical Services team.
- Identify and implement continual improvement initiatives.
- Minimum of 8 years+ experience in a pharmaceutical manufacturing organization, with expertise in Bulk Drug Substance manufacturing, with previous experience in cell culture unit operations or downstream unit operations, process/facility fit, New Product Introduction Technology Transfer. Previous experience of a technology transfer participated is advantageous.
- In-depth technical and operational knowledge of multiple unit operations in cell culture processing, centrifugation, depth filtration. Understanding of cause and effect of cell culture metabolism, or downstream processing with chromatography, UFDF, viral filtration and sub-micron filtration, pH adjustment and final fill.
- Understanding of analytical methods and corresponding signals to enable control strategy development and improvement.
- Strong understanding of technology transfer, bioreactor scale-up process or scaling principles for downstream unit operations.
- Comprehensive understanding of cGMP requirements for clinical/commercial biopharmaceutical manufacturing and the ability to implement best practices to ensure multi-product bulk drug manufacturing operations are cGMP compliant.
- Experience of Validation / Verification of GMP equipment or processes would be beneficial.
- Experience of process/facility fit, design, commissioning and start-up of a bulk drug substance facility is beneficial.
- Minimum undergraduate degree in chemistry, biology, engineering or related discipline.
- An advanced degree (MS, PhD) in Scientific (Biochemistry, Biology, Chemistry, Pharmacy) or Engineering (Chemical, Mechanical) related field is desirable.
Interested candidates should submit an updated CV.
Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to email@example.com
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***