Associate Director, manufacturing

Full time

Celldim 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 Celldim is searching for 2 Associate Directors for diagnosis kit and manufacturing. Celldim 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 new 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 and FDA guidelines
• Over 2 years of management experience, working with a diverse group of direct reports
• Strong leadership and interpersonal skills with the ability to motivate others, and communicate effectively
• Deep understanding and strong technical background in modern analytical science, and a demonstrated track record of their application in process development
• Alignment with Cellmig Values of teamwork, excellence, innovation, drive, compassion, and resilience
• Broad experience in discovery research, process development, and/or scale up experience preferred
• Experience in downstream process development
• USA citizen

Celldim offers a competitive salary and benefits.  Title and compensation based on experience and education.