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Role Summary:
Cell & Gene Therapy scientist will play a key role in conducting laboratory experiments and ensuring compliance with cGMP standards. The individual will perform routine and non-routine analyses, compile and interpret test data, maintain laboratory equipment, and support quality control and regulatory submissions.
Key Responsibilities:
- Perform experiments and laboratory activities necessary for process development.
- Conduct routine and non-routine analyses of in-process materials, raw materials, environmental samples, finished goods, and stability samples.
- Interpret test results, compare them to established specifications, and make recommendations on data release.
- Compile laboratory test data and perform appropriate statistical and technical analyses.
- Complete documentation to support testing procedures, ensuring accuracy and compliance.
- Calibrate, validate, and maintain laboratory equipment to ensure reliable operations.
- Supply quality control data necessary for regulatory submissions.
- Receive and inspect raw materials, ensuring compliance with specifications.
- Maintain lab cleanliness and safety standards at all times.
- Support cGMP stability and in-process quality control (IPQC) testing activities for cell and gene therapy products.
Qualifications and Educational Requirements:
- Master’s degree or PhD in Genetics, Biotechnology, or a related field.
- 1 to 2 years of experience working in a cGMP environment.
- Familiarity with cGMP practices and regulatory guidelines.
- Proven ability to write technical reports, protocols, and standard operating procedures (SOPs) with regulatory understanding.
Desired Qualities:
- Eagerness to learn and adopt new practices.
- Strong organizational skills with attention to detail.
- Problem-solving mindset to address challenges effectively.
- Multitasking capabilities in a fast-paced environment.
- Excellent reporting and documentation skills.
- Exceptional coordination and communication skills.
- Flexibility and adaptability to changing project needs.
- A team player with a collaborative mindset.
Why Join Helix Cell Therapeutics Ltd.?
- Work in a cutting-edge GMP facility contributing to transformative therapies.
- Collaborate with a passionate and innovative team in the biotechnology industry.
- Opportunities for professional growth and development.
- Be part of a mission-driven organization striving to make therapies accessible and affordable to all.
How to Apply:
Interested candidates are encouraged to submit their resume and cover letter to office.helixcell@gmail.com. Please include “Scientist – Cell & Gene Therapy” in the subject line of your email..