Technical Services Specialist
This job does not exist anymore.
Try running a new searchor browse our vacancies.
Or fill in the form below to receive job alerts.
| Job Type | Contractor |
| Area | Dublin, Ireland |
| Sector | Operations & Manufacturing |
| Start Date | |
| Advertiser | Hilda Lynn |
| Telephone | +3539833013 |
| Job Ref | #1002274 |
| Job Views | 136 |
- Description
- Technical Services Specialist 13743409 – Team Horizon
We are seeking applications for an experienced Technical Services specialist to join our client, who are a leading Bulk Drug biopharmaceutical company based in Dublin.
Why you should apply:
This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.
What you will be doing:
Provide process information and expertise to facilitate process/facility fit, and qualification of a large scale BDS facility through to NPI tech transfer start-up, 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.
What you need to apply:
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
Experience of Validation / Verification of GMP processes
Good interpersonal skills coupled with demonstrated ability to effectively work in a cross-functional global environment matrix organization, and in local group settings
Demonstrated ability to drive for results and lead innovation and change
Self-driven, able to prioritize, and to orchestrate multiple activities at once
Ability to deal with ambiguity and complexity and influence others across levels of the organization