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Lead Scientist in Cell Therapy Manufacturing
2 months ago
Job Title: Lead Scientist - Cell Therapy Manufacturing
Job Type: Full-Time
Northreach is a forward-thinking recruitment agency dedicated to linking organizations with exceptional talent in the Advanced Therapies domain. Our goal is to deliver a smooth and tailored recruitment journey for both clients and candidates, fostering a workplace that champions equality, innovation, and professional development.
About the Company:
Our client is an innovative biotechnology firm leading the way in cell-based treatment solutions. We are in search of a highly qualified and seasoned Lead Scientist to become a vital part of our MSAT team. This position presents a remarkable opportunity to play a key role in the progression of state-of-the-art T cell therapies aimed at addressing critical health issues.
Key Responsibilities:
- Deliver project oversight and technical guidance to production teams, acting as the steward of the manufacturing process.
- Facilitate development, technology transfer, and validation initiatives, ensuring effective collaboration through clear communication, scientific insight, and a focus on priorities and details.
- Build strong relationships and collaborate with cross-functional partners (Project Management, Quality Control, Quality Assurance, Supply Chain, Production, Analytical Development, Process Development, and Regulatory Affairs) to support technology transfers and process performance qualification campaigns.
- Drive the creation of processes and systems for data management, analysis, and trending.
- Identify opportunities for ongoing enhancement of manufacturing processes through trend analysis, advancements in manufacturing technologies, and adherence to new industry standards.
- Engage and present as a key project member in internal or external initiatives as a technical expert in drug product MSAT.
- Verify equipment qualification as part of the process validation framework (e.g., correct installation, efficient operation, robust performance).
- Establish training programs, mentor, and coach technical and production staff to cultivate high-performing technical operations and MSAT teams.
- Actively participate in the evaluation of deviations, root cause analysis, corrective and preventive actions (CAPA), and change control processes with a strong emphasis on quality, risk management, and regulatory compliance.
Qualifications:
- In-depth knowledge of immunology and cell therapy.
- Proven expertise in cell-based methodologies, including cell enrichment, culture, and formulation technologies.
- Ability to lead and manage a team while working independently and collaboratively with cross-functional teams across various locations.
- Resourceful in addressing challenges and capable of thriving in a dynamic environment.
- Experience collaborating closely with production teams, leading root cause investigations, and evaluating non-product quality impacting deviations.
- Responsible for authoring and reviewing batch records, bills of materials, and change controls, assessing the impact of any changes to processes, equipment, or procedures.
- Solid understanding of quality management systems.
- Familiarity with technology transfer and collaboration with contract development and manufacturing organizations is advantageous.
- Training in Six Sigma and/or manufacturing excellence methodologies is a plus.
Technical Skills:
- Exceptional time and project management capabilities.
- Minimum MSc in a relevant field with at least 4 years of experience in industry and/or academia.
- Demonstrated commitment to high-quality work and maintaining rigorous standards.
- Contribute to a culture that values scientific excellence, integrity, urgency, patient focus, and continuous improvement.
- Experience in cGMP development and/or cell therapy product manufacturing is highly desirable.
Personal Attributes:
- Ability to work collaboratively within a team, supporting each other and being accountable for project outcomes.
- Strong personal drive and goal orientation.
- Detail-oriented and precise.
- Professional and approachable communication skills.
- Motivated to solve problems in a practical manner.
- Exhibits strong organizational and prioritization skills to manage a diverse workload.
- Demonstrates a positive work attitude, reliability, and adaptability.
- Willingness to work across multiple locations.
Compensation and Benefits:
We offer a competitive salary package commensurate with experience, along with comprehensive benefits including medical, dental, and vision coverage, retirement plans, and opportunities for professional advancement within a rapidly evolving field.
Northreach is an equal opportunity employer committed to fostering diversity, equity, and inclusion in the workplace. We strive to create a welcoming and inclusive environment for all employees.