Senior Director, MS&T: Tech Transfer & Process Validation

KBI Biopharma, Inc.; Durham (NC); On-site; USD 180,000 - 240,000; Full time

Job summary

KBI Biopharma, Inc. in Durham, NC seeks a Manufacturing Science and Technology Director/Senior Director to lead tech transfer, process validation and support lab activities.

You will supervise a multi-disciplinary team of engineers and scientists and collaborate with Process Development, Quality, Supply Chain, Facilities and Manufacturing to ensure timely, compliant execution. Key focus areas include Stage 2 PPQ through Stage 3 CPV, cGMP production, and continuous improvement of transfer

Qualifications

• BS/MS/PhD with extensive biologics experience and tech transfer expertise.
• Be able to lead cross-functional collaboration across sites.
• Understanding of cGMP, quality systems and process validation.

Responsibilities

• Direct tech transfer, process validation and lab support for MS&T.
• Lead multi-disciplinary projects and strategic oversight across sites.
• Manage resources, recruitment and performance in the department.

Skills

Tech transfer

Process validation

cGMP knowledge

Team leadership

Biologics processing

Education

Bachelor's degree in Science or Engineering

Master's degree in related field

PhD in related field

Job description

KBI Biopharma, Inc. in Durham, NC seeks a Manufacturing Science and Technology Director/Senior Director to lead tech transfer, process validation and support lab activities.

You will supervise a multi-disciplinary team of engineers and scientists and collaborate with Process Development, Quality, Supply Chain, Facilities and Manufacturing to ensure timely, compliant execution. Key focus areas include Stage 2 PPQ through Stage 3 CPV, cGMP production, and continuous improvement of transfer