A growing biotechnology company is seeking a Process Development Scientist to advance the growth of cell and gene therapy. This position focuses on Upstream Processing (USP) and process characterisation for ATMPs (Advanced Therapy Medicinal Products) using innovative Process Analytical Technologies (PAT). The role involves working collaboratively with internal and external stakeholders, managing both commercial and collaborative biomarker discovery, process characterisation, and development projects.
Key Responsibilities:
* Collaborate with cross-functional teams to scope, plan, and deliver USP process characterisation and biomarker discovery projects.
* Apply knowledge of USP bioprocessing, PAT, and data analysis techniques to drive project success.
* Provide subject matter expertise in laboratory work, ATMP-related products, processes, and technical report preparation.
* Lead laboratory activities associated with USP and Biomarker discovery projects, including stock control, experimental design, and compliance with onsite procedures.
* Support and communicate effectively with internal and external stakeholders to disseminate new USP and PAT capabilities.
* Produce experimental plans, review data integrity, and ensure adherence to company policies.
* Present data at conferences and meetings, as appropriate.
* Plan and execute experiments to meet project deliverables and timelines.
* Work with technology providers to ensure leadership in USP and PAT technology development.
Required Skills:
* Experience in bioprocessing, particularly upstream processing using STR and other cell culture technologies (e.g., DASbox, BioBLU, ambr250, Univessel).
* Knowledge of AAV or iPSC culture processes is a plus.
* Experience with standard analytical assays such as flow cytometry, PCR, metabolite analysis, and cell counting is desirable.
* Familiarity with statistical tools, method validation, and Design of Experiments (DoE) for experimental design.
* Experience in integrating PAT technologies into bioprocessing workflows is beneficial.
* Proficiency in data handling and Microsoft Excel and Word.
* PhD or BSc with 3+ years of industrial experience in life sciences or bioengineering (or equivalent qualifications).
This is a great opportunity to work on cutting-edge technology within the biotechnology sector, with potential for career growth and development.
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