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Principal/Lead Data Specialist, MSAT

4 months ago

Stevenage, United Kingdom Autolus Limited Full time

Role Summary
The post holder will be highly motivated and organised, with extensive experience and knowledge of data science, data analytics, and data management. 

The role will be the primary data subject matter expert and will develop and improve process control, monitoring, and trending of multiple products at Autolus to ensure product quality and data integrity and traceability in accordance with regulatory requirements. They will work closely with Process Development, Analytical Sciences, Production, Quality Control, Quality Assurance, and Product Delivery departments, as well as external consultants and contract research organizations daily. They will also be responsible for data visualization and dashboards to facilitate data-driven decision-making and continuous improvement initiatives. In addition, they will be responsible for training and managing junior team members, ensure appropriate documentation of results and reports, and leading data analysis of clinical and manufacturing data to support data-driven evidence-based decision-making and strategic planning.

Please note that this is a full time role based primarily in our site in Stevenage (hybrid working). 

Key Responsibilities
•    Lead data entry and verification of process parameters and product quality attributes for the purpose of data analysis, monitoring, and trending as part of Continued Process Verification (CPV)
•    Apply statistical process control methodologies to create control charts, monitor process performance, detect trends, and implement real-time interventions to maintain product quality and compliance.    
•    Lead data gathering and analysis during the execution of the technology transfer of new products from process development into GMP manufacturing 
•    Develop and improve Continued Process Verification (CPV) program to support products throughout the 3 phases of Validation (Process Design, Process Qualification and Continued Process Verification)
•    Author technical reports (such as periodic CPV reports) and documentation (such as CPV Plan)
•    Collaborate with MSAT, Engineering, Quality, and Operations teams to identify key manufacturing challenges and opportunities for process optimization.
•    Responsible for analysing manufacturing and clinical data sets to extract meaningful insights and drive evidence-based decision-making
•    Leverage expertise in data analytics, statistical modeling, and programming to collaborate with cross-functional teams to support strategic initiatives and improve patient outcomes
•    Develop predictive models to forecast manufacturing outcomes, anticipate deviations, and proactively identify opportunities for process improvement and risk mitigation.
•    Set up systems that consolidate the data across the organization
•    Evaluate new technology and data systems for introduction into GMP manufacturing 
•    Collaborate with IT and data engineering teams to optimize data infrastructure, implement analytical tools, and ensure data integrity and traceability in accordance with regulatory requirements
•    Initiate change implementation of MSAT-owned projects and driving operational excellence (OPEX) through data-driven approaches working cross functionally with different stakeholders  
•    Drive digitalisation and business Intelligence (BI) initiatives for managing and analysing data to create and automate data visualizations, process dashboard visualizations, and reports to make analytics results available for operational decision making and strategic planning.
•    Develop real-time KPI, metrics, and dashboards for MSAT to aid with deviation management and change management
•    Stay abreast of emerging trends and best practices in manufacturing analytics, data science, and industry standards to ensure compliance and to drive innovation and excellence in MSAT initiatives.
•    Co-author the CMC section of regulatory submissions that support regulatory filings including INDs and BLAs.
•    Represent MSAT as an SME on specialized topics and ensure inspection readiness as required 
•    Support, train and mentor junior members of the team in collaboration with the managers within Training, Production and Quality departments. 
•    Support commercial readiness activities across multiple products
•    Other duties as required

Demonstrated skills and competencies 
•    Minimum of 5 years' experience in data science and analytics (E)
•    Minimum of 5 years' experience in relevant biotechnology or pharmaceutical industry (P)
•    Experience of training, mentoring and supervision of data personnel (E)
•    Good knowledge of GMP work environment (P)
•    Project Management experience working in a matrix environment (P)

Qualifications
•    Bachelor’s or Master’s degree in Statistics, Computer Science, Mathematics, Bioinformatics, or a related field (E) 
•    with 10 years of industry or an equivalent combination of education and experience (P)

Skills/Specialist knowledge
•    Analytical mindset with a passion for exploring and interpreting complex manufacturing data to drive process understanding and improvement (E)
•    Knowledge and understanding of Good Manufacturing Practices (GMP), regulatory policies, and ethical considerations in handling patient data  (E)
•    Proven ability to effectively lead and participate on teams (E)
•    Team player with strong interpersonal skills and the ability to collaborate effectively across diverse functional areas and influence decision-making through data-driven insights (E)
•    Ability to make decisions and work independently and as part of a team (E) 
•    Detail-oriented and results-driven, with a commitment to delivering high-quality work in a fast-paced environment (E)
•    Problem solving mindset with the ability to shift focus based on changing priorities (E)
•    Willingness to continuously learn new skills and to embrace new challenges and technologies in data science and analytics (E)
•    Experience in manufacturing data sources (Skyland, MES, LIMS) and data management platforms (E) 
•    Experience in data integration and visualization and data analysis tools (E) 
•    Experience in automation projects (E) 
•    Experience and interest in biotechnology, pharmaceutical or cell and gene therapy industry (P)