Senior R&D Chemist - QA (Medical Device / Pharmaceutical) - Tuas

at  Corestaff Pte Ltd

ABOUT THE COMPANY:

Our client is one of the leading pharmaceutical ophthalmic solutions manufacturers in the world, dedicated in providing sterile pharmaceutical ophthalmologic solutions, from prevention to delivery of care at every touchpoint, advancing wellness in hospitals, clinics and home-care sectors.

POSITION OVERVIEW:

The Senior R&D Chemist is responsible for designing and developing products to meet quality standards and regulatory requirements (cGMP, 21 CFR Part 211, EU MDD/MDR, ISO 13485). He/she coordinates and conducts testing in compliance with SOPs, ISO standards, and global market regulations for physical, chemical, and microbiological aspects.

REQUIREMENTS:

• Bachelor’s, Master’s, or PhD in Chemistry with at least 8 years of hands-on R&D experience in the pharmaceutical / medical device sector.
• Strong understanding in regulatory standards that include GLP, GDP, cGMP, 21 CFR Part 211, EU MDD/MDR, and ISO 13485.
• Proficient in Product Development, with experience in producing cost-effective and robust technologies.
• Strong leadership skills with a track record of problem-solving and team collaboration.
• Excellent communication skills and ability to work effectively within diverse teams.

• Lead and oversee a team of chemists in R&D, Technology Transfer, and Projects.
• Develop and implement technical testing methods to meet regulatory requirements for medical devices and pharmaceutical products globally.
• Design testing methodologies for new materials and products and ensure compliance.
• Drive technology transfer initiatives and projects from lab to production scale.
• Identify chemicals to enhance product shelf-life and performance.
• Guide the QC team in good laboratory practices and accurate result interpretation.
• Develop and transfer new chemicals, ensuring thorough equipment and method validation.
• Update SOPs to align with evolving standards and regulatory requirements.
• Support external audits and inspections by certification bodies.
• Practice Good Laboratory Practices, Good Documentation Practices, and 5S.
• Drive innovation and automation in testing processes for efficiency.
• Any other tasks or projects that are being assigned by the immediate supervisor or Head of Department, as and when required.