MSAT Specialist

1 month ago

City of London, United Kingdom Proclinical Staffing Full time
Job Description

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.

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