MSAT Engineer/Specialist

Kelly Services-Portugal; 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 is seeking an MSAT Engineer/Specialist for a contract to hire position at a pharmaceutical leader in Bristol, PA. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career.

Compensation:$40.00-52.00
Schedule:M-F, 1st shift
Duration:Contract to hire

SUMMARY

We are seeking an experienced and highly skilled engineer with expertise in bioconjugation processes, including Antibody Drug Conjugates (ADCs) and Antibody Oligonucleotide Conjugates (AOCs), to support development-to-clinical cGMP manufacturing operations. You will serve as the MSAT technical bridge between process development and manufacturing, ensuring successful technology transfer, manufacturing readiness, and sustained process robustness for highly potent and complex biologic drug conjugates across the product lifecycle.

RESPONSIBILITIES

• Provide technical leadership for technology transfer from internal or external process development teams into cGMP manufacturing, including facility fit assessments, scale up planning, and risk assessments.
  
• Lead transfer of bioconjugation processes into cGMP manufacturing from internal teams and external development partners.
  
• Author and revise batch records and master batch production documents to support cGMP clinical manufacturing.
  
• Draft and maintain cGMP documentation, including BOMs, specifications, SOPs, technology transfer documents, PFDs, and P&IDs, as required to support execution and readiness.
  
• Lead or support process investigations, deviations, CAPAs, and root cause analysis related to cGMP manufacturing.
  
• Champion process safety by translating OEB controls into practical manufacturing requirements for equipment, PPE, waste, and cleaning.
  
• Provide in-person and real-time manufacturing production support required for project success.
  
• Drive continuous improvement initiatives related to process robustness, documentation, and manufacturing efficiency.
  
• Technical training and knowledge management. Develop training content for new processes, new equipment, and new batch record revisions. Maintain a living knowledge package per program, including lessons learned, known failure modes, and standard responses.
  
• Adhere to all GLP, and cGMP requirements as well as company policies, procedures, and mission while fulfilling duties, responsibilities, and tasks.
  
• Serve as the MSAT subject matter expert (SME) for bioconjugation processes including ADCs and AOCs across early development through commercial lifecycle stages.

QUALIFICATIONS

• Minimum Bachelor’s degree in scientific or engineering discipline or equivalent with 3-5 years of experience in biopharma MSAT or technical operations with a focus on ADC and/or AOC processes.
  
• Proven track record in both development and clinical-stage support, including batch record authorship and process documentation.
  
• Working knowledge of GMP operations, including manufacturing floor support, deviation resolution, and change control.
  
• Hands‑on experience with conjugation chemistries, tangential flow filtration (TFF), Protein A, ion exchange (IEX), and hydrophobic interaction chromatography (HIC).
  
• Strong understanding of Microsoft Office Suite including basic functions and graphing within Microsoft Excel
  
• Familiarity with semi/fully automated manufacturing equipment
  
• Proven ability to troubleshoot bioprocess operations and equipment.
  
• Understanding of relevant analytical, processing, and scale-up calculations.
  
• Proven ability to build, modify, and utilize digital data storage, visualization, and analysis systems/tools.
  
• Strong interpersonal and communication skills, with the ability to interface effectively with cross‑functional teams and clients