Cell Therapy Biotechnologist: Clinical Development and Manufacturing Lead
1 day ago
Esco Aster Pte. Ltd. is a leading contract research development and manufacturing organization (CRDMO) that specializes in cell and gene therapy products.
Job Description:Clinical Development and Manufacturing LeadWe are seeking an experienced Clinical Development and Manufacturing Lead to join our team at Esco Aster Pte. Ltd. In this role, you will be responsible for leading the development and implementation of clinical trial materials and commercial products from early development through technology transfer for clinical trial material manufacturing and eventual technology transfer out and/or commercialization.
The successful candidate will have a strong background in cGMP practices and global regulatory requirements, with experience in bringing cell and gene therapy products through clinical development to market.
You will work closely with internal stakeholders, including cross-functional biotechnicians, to ensure seamless communication and collaboration throughout the product development lifecycle.
This is an excellent opportunity for a motivated and experienced professional to join our dynamic team and contribute to the advancement of cell and gene therapy products.
Responsibilities:- Lead the development and implementation of clinical trial materials and commercial products from early development through technology transfer for clinical trial material manufacturing and eventual technology transfer out and/or commercialization.
- Collaborate with internal stakeholders, including cross-functional biotechnicians, to ensure seamless communication and collaboration throughout the product development lifecycle.
- Ensure compliance with cGMP practices and global regulatory requirements.
- Develop and implement quality control procedures to ensure high-quality products.
- Lead training sessions for new employees and ensure knowledge transfer within the team.
- Bachelor's degree in Chemical Engineering, Pharmaceutical Science or relevant discipline.
- Minimum 2 years of experience in cGMP/aseptic environment in cell and gene therapy.
- Proven track record in regulatory strategy and interactions.
- Strong knowledge of cGMP practices and global regulatory requirements.
- Experience in bringing cell and gene therapy products through clinical development to market.
- In-depth knowledge of the drug development process and commercialization pathways.
We offer a competitive salary range of SGD $120,000 - SGD $180,000 per annum, depending on experience, plus benefits including medical insurance, annual leave, and opportunities for professional growth and development.
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