Summary : Our client a biologics company based in the midlands is looking for a Cell Culture Specialist to join it’s Technical Services team.
The successful candidate will be responsible for for providing scientific & technical support of (cell culture derived) drug substance manufacturing processes performed through all phases of the product lifecycle, including technology transfer, process scale-up, process validation, routine manufacturing, and process / continual improvement programs.
Responsibilities : 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 of products.
mammalian cell culture / downstream purification operations, 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, 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 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 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).
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. 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. 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.
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.