Principal/Senior Principal Downstream Bioprocess Scientist - Technical Services/Manufacturing Sciences
Role Overview:
The Principal/Senior Principal Downstream Bioprocess Scientist - TS/MS will play a pivotal role in introducing and supporting manufacturing processes within the downstream operations environment. This role is critical during the start-up phase and throughout routine manufacturing operations. The successful candidate will demonstrate exceptional technical expertise in downstream bioprocessing, employing advanced data-driven decision-making and problem-solving skills. This position emphasises the continuous improvement of process performance through the implementation of cutting-edge technologies and advancements, utilising the advantages of a digital plant through sophisticated data analytics and process analytical technology.
Key Responsibilities:
Scientific Expertise:
- Possess a profound understanding of downstream cell culture processes, including the control strategies specific to each molecule and the basis of critical attributes and specifications.
- Expertise in Chromatography: Proficiency in chromatographic techniques is essential for the purification and separation processes in downstream bioprocessing. The candidate must be adept at optimising chromatographic methods to ensure a high yield and purity of the final product.
Technical Support:
- Have a thorough understanding of each downstream unit operation, including its purpose, capabilities, and the impact of equipment on the overall process. This includes knowledge of filtration, centrifugation, and other separation techniques.
- Provide high-level technical support to the online process support team, ensuring excellence in process science, operational efficiency, and compliance with regulatory standards.
- Work closely with quality assurance, operations, and engineering teams, bringing deep technical expertise and scientific rigour to these collaborations to drive process improvements and innovation.
- Utilise advanced process monitoring tools and analytics to make informed, data-driven decisions that ensure process consistency, robustness, and efficiency. This includes real-time monitoring and troubleshooting of processes to maintain optimal performance.
Statistical Methodologies:
- Apply basic and advanced statistical methodologies to assign specifications, set validation acceptance criteria, define tech transfer criteria, determine material sampling criteria, conduct comparability assessments, and analyse batch data for comprehensive summary reports and product reviews.
- Ensure the seamless integration of process parameter requirements with Manufacturing Execution Systems (MES) and electronic batch records, capturing all regulatory, compliance, and process monitoring needs in manufacturing documentation.
- Identify, develop, and implement process improvements, participating actively in Lean Manufacturing initiatives to enhance efficiency, reduce costs, and improve product quality.
- Maintain and enforce strict compliance with all safety, regulatory, and quality standards, ensuring that all processes meet or exceed industry requirements.
- Contribute to the authorship and review of regulatory submissions, providing detailed and accurate responses to regulatory agencies to support product approval and compliance.
Qualification:
- A Bachelor's, Master's, or PhD in a relevant scientific discipline such as Engineering, Biology, Chemistry, or Microbiology.
- Experience:
- A minimum of 5 years of experience in the Biopharmaceutical industry, with significant experience in downstream processing.
Technical Knowledge:
- Extensive expertise in Chromatography, Process Monitoring, Deviations, Antibodies, and Downstream Processing is crucial.
- The candidate must demonstrate a deep understanding of these areas to ensure the highest standards of process performance and product quality.
- Demonstrated high productivity and technical acumen in biopharmaceutical roles, with a strong focus on downstream processing.
- A proven track record of continuous learning, curiosity, and the ability to adapt to new technologies and methodologies.
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