Technical Specialist- upstream
This vacancy has now expired
- The Technical Specialist – Cell Culture, has primary responsibility for providing scientific & technical support of (cell culture-derived) drug substance manufacturing processes performed at our clients site. Specifically the technology transfer of product(s). 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.
- Previous experience of a technology transfer in a cell culture capacity, cleaning validation and exposure to raw materials oversight setting is advantageous.
- Provide process information and analysis to facilitate process fit, and qualification of a large scale facility through to NPI tech transfer startup, PPQ validation, in a multi-product 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.
- Undertake technical risk assessments to support raw material assessment for NPI, update to Mass balances; development of materials listing/BOM’s to support process.
- Identify technical issues, and guide the resolution of same.
- Provide SME knowledge and understanding in manufacturing processes (upstream); cause and effect, scale-up principles, and process validation strategies.
- Shape and develop strategic approaches for Technical Services in areas such as downstream purification processes, technical studies supporting process 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 manufacture processes. Develop and shape standards and strategy documents to support Manufacturing and Tech Transfer. Provide SME support for the area on key audit topics.
- Collaborate with Global Technical Operations and Engineering to implement site-specific process control strategy, complete process risk assessments and associated documentation to support equipment qualification activities, Technical supporting studies and concurrent and prospective validation studies and key technical strategies.
- Undertake QRM risk assessments.
- Perform risk assessments to support the technology transfer e.g. FEMA'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.
- 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, 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 continuous improvement initiatives.
- Minimum of 2-3 years+ experience in a pharmaceutical manufacturing organization, with expertise in Bulk Drug Substance manufacturing, with previous experience in cell culture unit operations, process/facility fit, New Product Introduction Technology Transfer. Previous experience of a technology transfer in a cell culture capacity 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.
- Understanding of analytical methods and interpretation of results with impact on the process
- Understanding of technology transfer and bioreactor scale-up process
- 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.
- Ability to drive for results independently and adapt to rapidly changing priorities
- Experience in Technology Transfer activities is advantageous
- Knowledge or experience of start-up or systems would be ideal
If you have a background in Drug Substance/Mammalian cell product transfer or introduction or are a keen bio process Specialist and are keen to progress further in your career, please apply with your CV now.
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta Consultancy Services does not sponsor Visa applications.
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