- 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.
- 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.
- 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.
- 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
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MSAT Specialist - City Of London, United Kingdom - Proclinical Staffing
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
EXPERIENCE
TECHNICAL SKILLS
PERSONAL QUALITIES
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.