Senior / Principal Scientist - MSAT

ABOUT US

At Quell we seek to deliver truly innovative, life-changing therapies for our patients. Our vision as a company is to build a major global biopharmaceutical company bringing transformational and valued therapies for a range of autoimmune and inflammatory diseases, as well as preventing rejection in organ transplantation, based on modular engineered Tregs.

OUR COMPANY

Quell Therapeutics Ltd ("Quell"), the world leader in the development of engineered T-regulatory (Treg) cell therapies for serious medical conditions driven by the immune system, announced it has raised $156 million in an oversubscribed Series B financing. The financing round was co-led by Jeito Capital, Ridgeback Capital Investments, SV Health Investors and Fidelity Management & Research Company LLC with participation from founding investor Syncona. New investors include British Patient Capital through its Future Fund: Breakthrough program, Janus Henderson Investors, Monashee Investment Management, Point72 and funds managed by Tekla Capital Management LLC

THE ROLE

Senior/Principal Process Engineer – Manufacturing Science & Technology (MSAT)

We are looking to recruit a Senior/Principal Process Engineer Manufacturing Science & Technology to lead 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/Principal Scientist to contribute to a key part of our work. Quell offers an exciting and highly dynamic environment focused on developing cutting-edge Treg therapies.

MAIN RESPONSIBILITIES

To become a process subject matter expert and provide technical expertise and troubleshooting support to GMP production team during manufacture of Quells clinical products, including being 'person-in-plant' and/or 'on-call' during critical unit of operations.

• Take a leading role process-related root-cause-analysis, corrective action preventive action (CAPA) and change control processes with strong focus on quality, risk mitigation and regulatory compliance.
• You will establish training programmes, coach, mentor, and train technical and production operators to ensure a high-performing GMP production operations and MSAT teams.
• Lead the development of processes and systems for the management of data, trending, and analysis.
• Manage 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.
• 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).

EXPERIENCE supervising or mentoring junior staff.

• Strong background and knowledge of GMP manufacture
• Good 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) is advantageous
• Knowledge of tech transfer and working with CDMOs desirable.

TECHNICAL SKILLS

• Strong background working in cGMP development and/or cell therapy product GMP manufacturing is highly desirable.
• 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.

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 Quell and the wider business.
• Flexibility to work across multiple sites in London (Guys and St Thomas' (GSTT) and White City)