Associate Director

6 days ago

Singapore GDMC PTE. LTD. Full time

At Genetic Design and Magic Corporation (GDMC), our mission is to exponentially increase the availability of genetic medicines and change millions of patients’ lives. We achieve this by partnering and supporting early-stage companies and investigators with innovative therapeutic modalities such as gene therapies or nucleic acids. Leveraging our expertise in process development and manufacturing, we accelerate our partners ability to bring their ideas through clinical trials and into market. We are growing quickly and looking for talented individuals eager to build something new, challenging and impact lives with transformative medicines.

GDMC is expanding our Quality team and is seeking an exceptional Associate Director (Quality Control). As the Associate Director in the Quality department, you will be responsible for developing the quality control strategy for GDMC as well as lead the team to ensure the quality standards of GDMC products. You will also be exposed to cutting edge therapeutic modalities and support operational readiness of a new facility. If you’d like to play a part in bringing the next life-saving innovations to market, we want you

**Responsibilities**
- Responsible for the development and implementation of Quality Control strategy.
- Establishment, review, approve and maintenance of Quality Control standards, procedures, and test specifications.
- Build and manage the QC team to support cGMP operations to perform test procedures to determine the quality, uniformity and stability of raw materials and finished products as per our partners’ requirements, current Good Manufacturing Practices (cGMP’s) and current Good Laboratory Practices (cGLP’s).
- Responsible for establishing Sample Management, Microbiology, Environmental Monitoring, Sterility Lab, Raw Material, Analytical, Biochemistry, Analytical Method Validation, Method Suitability Test, Method Transfer, QC Systems (LIMS, LEQ Support) teams to support ATMPs Quality Control Testing.
- Qualify analytical methods, including compendial methods. Technological transfer from Analytics team to QC team.
- Lead, review, and approval of Quality Events such as Change Controls, deviations / non-conformances, OOS, LIR raised by QC Labs as needed.
- Provide R&D support for the introduction of new raw materials and new product launches.
- QC Lead for audits/inspections by customer and regulatory agencies.
- Ensuring timely release of test results and approval of certificate of analysis to release batches on time.
- Involve in the generation of the Annual Product Reviews.

**Requirements**:

- Master’s in Biotechnology, Bioengineering, Pharmaceutical Sciences, Chemistry, Chemical Engineering or related fields. PhD preferred.
- Innovative and analytical thinker with outstanding interpersonal, communication, and leadership skills
- Thorough understanding of current regulatory requirement of cGMP biologics and pharmaceutical industries.
- Experience in handling audits in US FDA, EU EMA, TW FDA and SG HSA.
- Good understanding of PIC/s GMP Guides, ICH guidelines and USP.
- Able to multi-task and prioritise work

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