Master Seed Facility Scientist

Role Description

Work as a member of the Master Seed Team to produce biological and biopharmaceutical Master and Working Seed / Cell Stocks for global seed registration in compliance with USDA, EP, and FDA guidelines. Perform operations and maintain compliance with Good Manufacturing Practices (GMP's). Write reports for submission to USDA, EP, and FDA to support registration of new seeds and extension of seed registration into additional countries.

Position 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.
• Work in a GMP Grade A / B environment fulfilling requirements for primary and secondary gowning and demonstration of excellent aseptic skills.
• Author and approve seed and cell reports to support regulatory filings for new product registrations globally.
• Coordinate seed testing protocols and sample submissions with external CROs to support global testing of seeds.
• Responsible for SAP system activities to include generation of new material numbers and data sets, inventory management, movement of seeds across sites, test article workflow through ZLIMS
• Manage inventory to include testing submissions, ensuring proper storage, inventory receipt and reconciliation, and inventory transfers and shipments.
• Data Entry, verification and handling, record keeping in accordance with scientific protocol and applicable Standard Operating Procedures using office applications such as Word, PowerPoint, and Excel.
• Assist in ordering and maintaining adequate supplies in the seed production facility.
• Demonstrate safe work habits and maintain a safe work environment. Understand and comply with safety SOP's and procedures (Material Safety Data Sheet (MSDS) guidelines, Near Miss, Personal Protective Equipment (PPE), biohazard training, Monthly Safety training, etc.)
• Knowledge of computer systems to include maintenance of SharePoint Site and management of documents in Veeva Vault (routing document for approval and uploading documents for archive).
• Demonstrate good interpersonal and communication skills within and outside the department using verbal, written, and non-verbal skills
• The ideal candidate would possess :

Excellent communication, organizational, record keeping and computer literacy skills.

Educational Requirements / Experience :

Full time

Regular

Colleague

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