Senior MSAT Engineer: mAb Tech Transfer & Manufacturing

Kyowa Kirin Co.; Sanford (NC); On-site; USD 135,000 - 155,000; Full time

Benefits offered by this job

401(k) with Company Match

Annual Bonus Program

Generous PTO and Holiday Schedule

Job summary

Kyowa Kirin North America in Sanford, NC is seeking a Senior MSAT Engineer to provide technical leadership for the transfer, manufacturing, and testing of mAb drug substances. This role drives robust process development and seamless technology transfers, collaborating with Global R&D, CDMOs, and manufacturing teams.

The ideal candidate has 5+ years of purification experience, strong DoE and statistical skills, and a deep understanding of cGMP requirements.

Qualifications

• Bachelor’s or Master’s degree in Pharmaceutical Sciences, Engineering, or related life sciences.
• Master’s degree is preferred.
• Minimum of five years purification experience in biotechnology.

Responsibilities

• Provide technical leadership for commercialization of mAb drug substances.
• Lead transfer of drug substance processes to/from the facility and optimize processes.
• Lead investigations of deviations and perform DoE-based optimization.
• Ensure compliance with cGMP and coordinate with QA and Manufacturing.
• Author and review technical and transfer documentation; monitor batch records.

Skills

Monoclonal antibody processes

Process transfer

DoE

Statistical analysis

Troubleshooting

Quality systems

Education

Bachelor’s or Master’s degree in Pharmaceutical Sciences, Engineering, or related life sciences

Master’s degree preferred

Tools

Bench-scale lab equipment

Microsoft Office Suite

DoE software (statistical tools)

Job description

Kyowa Kirin North America in Sanford, NC is seeking a Senior MSAT Engineer to provide technical leadership for the transfer, manufacturing, and testing of mAb drug substances. This role drives robust process development and seamless technology transfers, collaborating with Global R&D, CDMOs, and manufacturing teams.

The ideal candidate has 5+ years of purification experience, strong DoE and statistical skills, and a deep understanding of cGMP requirements.