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Cell Culture Specialist, Dublin



Dublin, Ireland 

Job Category:

Biotech/Pharma, Science

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Job Description:

We are seeking applications for an experienced Cell Culture Specialist for our client, who is a leading biopharmaceutical company based in Dublin.

The Cell Culture Specialist Technical Services has primary responsibility for providing scientific & technical support of (cell culture derived) drug substance manufacturing processes performed at 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.

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.
  • There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
  • Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.

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 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/downstream purification), 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 the client 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/ downstream purification operations, cause and effect, scale up principles, QRM, process validation strategies) and apply and build on the client product portfolio.
  • Shape and develop strategy approaches for Technical Services in areas such as Mammalian Cell Culture technologies, downstream purification technologies, Technology Transfer, PPQ, CPV approach and so forth, maintaining industry trends and advances.
  • Ensure current with Regulatory frameworks/changes, and industry trends, ensuring robust and scientifically sound rationale and justifications are embedded into the client’s 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.
  • Develop and update predicator modelling, and the use of data monitoring systems to identify trends.
  • Be a QRM Risk facilitator/mentor for others, aligning approaches to risk assessment per company procedures.
  • 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:

  • 8 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
  • 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.
  • 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 equipment or processes would be beneficial
  • Experience of process/facility fit, design, commissioning and start-up of a bulk drug substance facility is beneficial
  • Engage in continual improvement through assessment and use of new PAT technologies, by design of scientifically robust assessment protocols and study design
  • Good interpersonal skills coupled with demonstrated ability to effectively work in a cross-functional global environment matrix organization, and in local group settings
  • Ability to develop, build, present and defend technical and scientific approaches in both written and verbal form.
  • Can effectively partner with and influence stakeholders without direct solid line authority
  • Drives technical decisions balancing product quality and operational requirements
  • Ability to drive for results independently and adapt to rapidly changing priorities
  • Experience of Technology Transfer and post launch process improvements.
  • Knowledge or experience of start-up or systems would be ideal
  • Excellent communication skills, and able to effectively influence across all levels of the organization both internal and external.
  • Detail orientated, technical writing competency
  • Excellent organizational skills with strategic thinking and vision for Technical Services at ADMF
  • 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
Company Info
Team Horizon
1 Cedar Crescent, Cedar Park, Westport, Co. Mayo
Westport, Ireland
Phone: +353 98 50600
Web Site: http://www.teamhorizon.ie
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