Website Ref: TPM03942
A Technical Services Specialist is required for a biotech company in West Dublin.
- Provide process information and expertise to facilitate process/facility fit, and qualification of a large scale BDS facility through to NPI tech transfer startup, PPQ validation, launch and continual improvement of existing and future products in a multi-product BDS facility.
- Provide technical direction and provide SME oversight in an area of BDS manufacturing; (mammalian cell culture), be the SME (Cell Culture) to develop and defend technical rationale during regulatory audits and inspections.
- Provide scientific and technical input to facilitate decision making.
- Provide input and engage with Product Lifecycle Management (PLCM) of products.
- Identify technical issues, improvement initiatives and guide resolution/completion of same.
- Possess deep technical knowledge and understanding in BDS manufacturing processes; (mammalian cell culture, cause and effect, scale up principles, QRM, process validation strategies) and apply and build on product portfolio.
- Shape and develop strategy approaches for Technical Services in areas such as Mammalian Cell Culture technologies, Technology Transfer, PPQ.
- Ensure current with Regulatory frameworks/changes, and industry trends, ensuring robust and scientifically sound rationale and justifications are embedded into Technical and Manufacturing strategies.
- Collaborate to influence the design and implementation robust process control strategies, process risk assessments and associated documentation to support equipment qualification activities, PPQ studies, and key technical strategies supporting process improvements for yield increases and improvement of manufacturing robustness.
- Provide Technical input, review/approval into documentation associated with materials, manufacturing control and enterprises systems (MCS/MES) including manufacturing and technical documentation.
- Ongoing Subject Matter Expert technical support to Technical Services and Manufacturing Operations by providing technical expertise for investigation and resolution for process deviations, CAPAs, change controls.
- May be required to work periodically out of normal business hours (temporary shift working or per out of hours policy) during periods of engineering and validation batch execution, as well as any other duties as required.
- Author, review and approval of reports in support CMC sections of 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.
Qualifications & Experience:
- 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.
- Min. 5 years+ experience in a pharmaceutical manufacturing organization.
- Bulk Drug Substance manufacturing, with previous experience in cell culture unit operations, process/facility fit, New Product Introduction Technology Transfer.
- In-depth technical & operational knowledge of unit operations in cell culture processing, centrifugation, depth filtration.
- Understanding of cause and effect of cell culture metabolism
- Strong understanding of analytical methods and corresponding signals to enable control strategy development and improvement.
- Strong understanding of technology transfer, bioreactor scale-up process and scaling principles.
- Comprehensive understanding of cGMP requirements for 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 processes.
- Ability to develop, build, present and defend technical and scientific approaches in both written and verbal form.
To apply for this job please visit tandempm,ie.