Master Seed Facility Scientist

Role Summary

Master Seed Facility Scientist responsible for producing biological and biopharmaceutical Master and Working Seed/Cell Stocks for global seed registration in compliance with USDA, EP, and FDA guidelines, in GMP environments, and writing regulatory reports.

Responsibilities

• Produce mammalian and insect-derived cell lines using adherent and suspension culture methods.
• Generate bacterial, viral, yeast, and parasite seeds using flask, fermentor, and bioreactor techniques.
• Operate in a GMP Grade A/B environment with primary and secondary gowning and aseptic skills.
• Author and approve seed and cell reports to support regulatory filings for global product registrations.
• Coordinate seed testing protocols and sample submissions with external CROs to support global testing of seeds.
• Handle SAP system activities including generation of new material numbers and data sets, inventory management, movement of seeds across sites, and workflow through ZLIMS.
• Manage inventory, testing submissions, storage, receipt, reconciliation, transfers, and shipments.
• Perform data entry, verification, and record keeping per scientific protocols and SOPs using Word, PowerPoint, and Excel.
• Assist in ordering and maintaining adequate supplies in the seed production facility.
• Maintain safe work habits and environment; comply with safety SOPs and procedures (MSDS, PPE, biohazard training, Monthly Safety training).
• Maintain knowledge of computer systems including SharePoint and Veeva Vault for document routing, approval, and archiving.
• Demonstrate strong interpersonal and communication skills within and outside the department.
• The ideal candidate would possess: strong communication, organizational, record-keeping, and computer literacy; ability to develop and maintain effective working relationships; self-starting with minimal supervision; adaptability to changing workloads; multitasking with deadlines; strong technical writing for scientific/technical reports.

Qualifications

• Bachelor's degree and/or equivalent in a scientific discipline with emphasis in microbiology/biochemistry/medical technology or related fields.
• Experience with bacteria, viruses, and cell lines.
• Experience in a GLP/GMP environment or understanding of GLP/GMP regulations is desirable.
• Computer skills: Microsoft Word, Excel, and Outlook.

Education

• Bachelor's degree or equivalent work experience in a relevant scientific discipline.

Additional Requirements

• None