Director, Scientific Affairs

Job Description

The Director of Scientific Affairs is driving end to end new product development throughout its lifecycle, from idea generation, lab scale, clinical trial, till its full commercialization.

Oversee projects and provide scientific insight and support as needed to ensure overall project continuity, direction, and success from tech transfer, development, through scale-up, manufacturing, and commercialization.

• Closely support CDMO commercial on identifying and developing new products lines with visible business return.
• Lead a team of scientists to provide technical expertise implementing projects.
• Responsible for developing the process and test methods and generating the products with commercial viability at Lab/Bench Scale.
• Support the Operation department in commercial/market development and support their output of pilot and subsequent scale products that meet customer requirements.
• Responsible for the testing work during product development, including lab scale batches, pilot batches, clinical batches, engineering batches, PV batches, etc., and work closely with QA/QC to ensure the smooth test method transfer.
• Responsible for providing the corresponding content for regulatory filing and supporting the declaration work of RA department.
• Oversee projects and provide scientific insights, technical advice and problem-solving to support the overall project continuity, direction, and success from tech transfer, development, and scale-up through manufacturing and commercialization.
• Identifies patterns or connections between or among situations to identify key or underlying issues.
• Possesses the skill to obtain necessary facts and generate informed solutions.
• Coordinate with project management to monitor progress of projects against the project plan.
• Collaborate with Business Development, Quality, Regulatory Affairs and Operations.
• Monitor and assist with the management of patents.
• Attend technical and industry meetings to monitor the state of technology industry-wide.

Qualifications:

• Bachelor Degree or above in science related
• More than 10 years of Research and Development related work experience