MSAT Engineer - Bioconjugation & ADCs (Contract-to-Hire)

Mykelly; Bristol Township (Bucks County); On-site; USD 55,000 - 72,000; Full time

Job summary

Kelly Science & Clinical seeks an experienced MSAT Engineer/Specialist for a contract-to-hire role in Bristol, PA, to bridge development and manufacturing for highly potent biologics. You will lead technology transfer, scale-up planning, and cGMP readiness across ADC and AOC platforms, ensuring robust processes and compliant documentation.

The position requires hands-on conjugation chemistries, TFF, Protein A, IEX, and HIC experience, with strong GMP knowledge, batch-record authorship, and

Qualifications

• Bachelor’s degree in a scientific or engineering field; 3–5 years in biopharma MSAT or technical operations with ADC/AOC focus.
• Experience with GMP operations on manufacturing floors, deviations, and change control.
• Hands-on conjugation chemistries and unit operations like TFF, Protein A, IEX, and HIC.

Responsibilities

• Provide technical leadership for technology transfer into cGMP manufacturing and lead scale-up planning and risk assessments.
• Lead transfer of bioconjugation processes into cGMP manufacturing from internal and external partners.
• Author and revise batch records and master batch production documents to support cGMP clinical manufacturing.
• Draft and maintain cGMP documentation (BOMs, specifications, SOPs, transfer documents, PFDs, P&IDs).
• Lead or support investigations, deviations, CAPAs, and root cause analyses.
• Champion process safety by translating OEB controls into manufacturing requirements for equipment, PPE, waste, and cleaning.
• Provide in-person and real-time production support and drive continuous improvement of process robustness and efficiency.
• Develop training content for new processes, equipment, and batch record revisions; maintain a living knowledge package.

Skills

Interpersonal communication

GMP operations knowledge

Batch record documentation

Education

Bachelor’s degree in scientific or engineering discipline

Tools

Conjugation chemistries

TFF

Protein A

IEX

HIC

Automated manufacturing equipment

Job description

Kelly Science & Clinical seeks an experienced MSAT Engineer/Specialist for a contract-to-hire role in Bristol, PA, to bridge development and manufacturing for highly potent biologics. You will lead technology transfer, scale-up planning, and cGMP readiness across ADC and AOC platforms, ensuring robust processes and compliant documentation.

The position requires hands-on conjugation chemistries, TFF, Protein A, IEX, and HIC experience, with strong GMP knowledge, batch-record authorship, and