Full time
Cellmig Biolabs is a world-class team making pioneering discoveries into translational medicines for the diagnosis and pharmatherapy of cancer metastasis and growth. We have successfully developed new organelle of cytocapsulae/cytocapsular tubes related breakthrough biotechnologies in generating biomolecules propertied powerful potentials targeting tumor metastasis. We are producing the in vitro diagnosis products (kits and devices) for the detection of cancer metastasis in all (early, developing and late) stages.
The Cellmig is searching for 2 Associate Directors for diagnosis kit and manufacturing. Cellmig offers growth potential and a stimulating environment with a culture of excellence in science, engineering, and business. You will be part of an integrated, interdisciplinary team developing powerful recent medical diagnostic products for cancer metastasis diagnosis.
Roles And Responsibilities
- Design, organize and manage resources and progresses of overall manufacturing development activities
- Identify potential gaps and risks of existing processes/procedures, prioritize, and develop plans
- Strategize development plans for manufacturing with external industrial standards
- Accumulate process knowledge to maintain and strengthen Cellmig’s global leadership position on the manufacturing of products
- Establish best practice for PMO and PPMO process development to provide guidance for future technology development within a QbD framework
- Evaluate emerging technologies and their potential incorporation into the existing processes/operations based on risk and impact assessment
- Collaborate with Manufacturing, Supply Chain, Quality Control, and Quality Assurance to support ongoing manufacturing activities
- Support regulatory filings
Education And Skills Requirements
- D in biomedical engineering or related areas
- Over 3 years of process development or manufacturing experience, familiar with current ICH