Total 2 manufacturing job vacancies in D19 Serangoon Garden, Hougang, Sengkang, Punggol

POSITION SUMMARY

You will be a key member of our Manufacturing team, responsible for manufacturing processes. Over time, this role will involve line management of a technical team. The candidate should have prior experience in manufacturing, specifically in the field of cell and gene therapy, ideally within aseptic sterile manufacturing.

ESSENTIAL JOB FUNCTIONS

1. As a key member of the team you will be ensuring that biopharmaceutical products are manufactured to the highest standard of quality within a GMP (Good Manufacturing Practice) regulated environment.
2. Observe strict aseptic and sterile manufacturing practices for cell culture and other cleanroom related activities to ensure compliance to current Good Manufacturing Practice (cGMP).
3. You will either be responsible for the production of CAR-T and TCR-T cell products in accordance with the Batch Manufacturing Record (BMR).
4. As technical owner, be a reviewer of manufacturing documents such as batch manufacturing records, SOPs, forms, and monitoring / log sheets whilst ensuring accuracy and compliance to cGMP and GDocP standards.
5. Responsible for overseeing closure of batch record review and deviations write ups to ensure timely batch release of the final product.
6. Utilize manufacturing process operations and commercial facility experience to participate in cross functional working groups as a user representative to drive the design and implementation of manufacturing related workflows.
7. Ensure and maintain the condition of GMP Facility, cleanroom, and associated manufacturing equipment.
8. Develop comprehensive safety risk assessments and adhere to all environment, health, and safety (EHS) guidelines.

EXPERIENCE REQUIREMENTS

• 1 to 3 years in a GMP biopharmaceutical manufacturing related role.
• Applicant must be familiar with a GMP environment, fundamental quality systems (deviation, corrective action preventative action, change control, etc) and regulatory compliance expectations on manufacturing floor.
• Working understanding of Operations, QC, QA, Process Development, Supply Chain and related functions.

WORK ENVIRONMENT

• Work in a cleanroom environment.

EDUCATIONAL REQUIREMENTS

• Minimum Degree (Biotechnology/Life Science)

Role: Cell Manufacturing Lead

Reporting to: VP(CMC) & Chief Scientific Officer

Job scope:

1. Providing technical and strategic leadership for the Chemistry, Manufacturing, and Controls (CMC) of company’s clinical assets.
2. Execute CMC strategy and submission plans to support regulatory filings for clinical trial applications in Singapore and US.
3. Build and manage the cell manufacturing and quality control team in Singapore.
4. In charge of the GMP cell manufacturing and process development in Singapore.
5. Act as the Manufacturing Sciences and CMC expert during audits and interactions with regulatory agencies.
6. Drive rigorous assessment of CMC issues, decisions to ensure the compliance with regulatory bodies’ requirement.

Requirement:

1. Advanced degree in life sciences/pharmaceutical sciences/biomedical research; minimum MS, preferred PhD.
2. Experience in CAR-T, TCR-T or other cell therapies.
3. Familiar with immune cell manufacturing, flow cytometry analysis; Cytokine measurement assays; qPCR assays; etc.
4. Self-motivated, good interpersonal skills.
5. Project management experience. • Able to write/read Chinese will have an advantage.