Senior Specialist, Data Quality Analysis

3 weeks ago

City of London Greater London, United Kingdom Proclinical Staffing Full time

THE ROLEEnsure you read the information regarding this opportunity thoroughly before making an Scientist MSAT (Cell Process)We are looking to recruit a Senior Scientist MSAT (Cell Process) to join a team of cell process subject matter experts (SMEs), providing process stewardship, technical support and connectivity between process development and manufacturing sites.This position offers an excellent opportunity for a talented and motivated Senior Scientist, Scientist I/II to contribute to a key part of our work. Our client offers an exciting and highly dynamic environment focused on developing cutting-edge therapies.MAIN RESPONSIBILITIES

• To provide project management and technical expertise to production teams as owners of the manufacturing process.
• Support development, tech-transfer, and validation activities, ensuring close partnership through open and transparent communication, scientific and strategic understanding, and attention to priorities and details.
• Establish effective relationships and partner with cross-functional stakeholders (PM, QC, QA, Supply Chain, production, AD, PD and Regulatory) as needed to enable tech transfers and PPQ campaigns.
• Lead the development of processes and systems for the management of data, trending, and analysis.
• Assess opportunities for continuous improvement of the manufacturing processes based on trend analysis, advances in manufacturing technology and controls and new industry standards.
• Participate and present as an integral project member of internal or external projects as a drug product MSAT technical expert.
• Confirm equipment qualification as a part of the process validation process (e.g. correct installation, efficient operation, robust performance).
• You will establish training programmes, coach, mentor, and train technical and production operators to ensure a high-performing technical operations and MSAT teams.
• Take a active role in the evaluation of deviations, root-cause-analysis, corrective action preventive action (CAPA) and change control processes with strong focus on quality, risk mitigation and regulatory compliance.

EXPERIENCE

• Supervising or mentoring junior staff.
• Detailed understanding of immunology and cell therapy.
• Demonstrable expertise in cell-based techniques including cell enrichment, culture, and formulation technologies.
• Ability to lead and manage a team, work independently and collaboratively with cross-functional teams across multiple sites.
• Resourcefulness in overcoming challenges and possess the ability to thrive in a fast-paced environment.
• Experienced in working closely with production teams, leading root cause analysis and assessing non-product quality impacting deviations.
• Authors and reviews batch records, bill of materials and change controls. Assesses change controls for impact of any change to the process, equipment, or procedures.
• Good understanding of working with quality management systems (e.g. Q-Pulse)
• Knowledge of tech transfer and working with CDMOs desirable.
• Training in Six Sigma and/or manufacturing excellence methodologies is advantageous.

TECHNICAL SKILLS

• Excellent time and project management skills.
• Minimum MSc in relevant study field and 4 years' experience in industry and/or academia
• Proven commitment to high quality work and maintenance of high standards.
• Contribute to a culture that embraces scientific excellence, integrity, urgency, patient centricity, and continuous improvement.
• Experience working in cGMP development and/or cell therapy product manufacturing is highly desirable.

PERSONAL QUALITIES

• Ability to work collaboratively within a team, supporting one another and held accountable for project deliverables.
• Personal drive and goal orientation.
• Detail-orientated and accurate.
• Professional and personable communication skills.
• Driven to solve problems pragmatically.
• Demonstrates strong organisational and prioritisation skills to manage a diverse workload.
• Excellent working attitude, reliability, and flexibility.
• Desire to work with integrity and act as an ambassador for the client and the wider business.
• Flexibility to work across multiple sites in London

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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