Sr. MSAT Specialist

2 weeks ago

Philadelphia, United States Planet Pharma Full time

Sr. MSAT Specialist (Second Shift)

Location: Philadelphia, PA.

Compensation: ~$120K (flexible depending on experience), plus 10% bonus structure and long-term incentives (stock options). Shift differential (likely 18%) for 2nd shift.

Shift: Monday to Friday, 3:00 PM - 11:30 PM


Position Overview:

The Senior MSAT Specialist is a key subject matter expert in Manufacturing Science and Technology (MSAT) with a focus on cell therapy processes. This role involves providing technical expertise across manufacturing operations, data analysis, deviation investigations, and technology transfer for cell and gene therapy production. The position also includes the execution of laboratory activities, authoring protocols and reports, and supporting the training and development of new team members.


Key Responsibilities:

  • Manufacturing Process Expertise: Serve as the technical SME for MSAT in cross-functional meetings, providing insights into cell therapy and GMP manufacturing processes.
  • Escalation Management: Act as the primary MSAT point of contact for study, clinical, and commercial manufacturing execution escalations, overseeing multiple cell and gene therapy GMP processes.
  • External Manufacturing Support: Perform Person-In-Plant (PIP) responsibilities at Contract Manufacturing Organizations (CMOs), ensuring consistent production execution at external facilities and alignment with internal practices.
  • Training & Support: Provide MSAT oversight and training to manufacturing personnel in the cleanroom environment and support onboarding of new MSAT specialists.
  • Technology Transfer & Process Improvement: Lead technology transfer campaigns for new product introductions and process improvements, working closely with internal and external manufacturing teams.
  • Documentation Ownership: Author and manage documentation such as Change Control (tech transfer, process improvement, emergency), Deviations, CAPAs, Action Items, investigational protocols, validation protocols, SOPs, and other MSAT-related reports.
  • Quality Systems & Investigations: Manage MSAT department quality system metrics and oversee complex investigations (CAPA, Deviations), including risk analysis, Kaizen, and GEMBA activities.
  • Data Analysis & Process Optimization: Analyze manufacturing process data, identify trends, and implement improvements to enhance operational efficiency.
  • Laboratory Activities: Execute hands-on experiments in the MSAT lab (when applicable) to support process optimization and troubleshooting.
  • Compliance: Ensure adherence to policies, and safety regulations (OSHA, SDS, SOPs).


Required Qualifications:

  • Education: Bachelor’s degree in a relevant discipline (e.g., Life Sciences, Engineering) or equivalent industry experience.
  • Experience: Minimum 5 years of hands-on experience in clinical or commercial production and/or process development within the life sciences industry.
  • Skills & Expertise:
  • Strong knowledge of cell culture, aseptic techniques, and GMP systems in a manufacturing setting.
  • Proven experience with technology transfer and manufacturing process tech transfer.
  • Proficiency in analyzing and interpreting manufacturing data and identifying process improvements.
  • Excellent written and verbal communication skills with strong technical writing abilities.
  • Ability to work cross-functionally and manage projects effectively within a fast-paced environment.


Preferred Qualifications:

  • Cell Therapy Experience: Prior experience in cell therapy manufacturing is highly preferred.

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