MSAT Specialist - Cell Therapy

THE ROLE

Senior 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.