Position Summary: 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 registrations into additional countries.
- Produce mammalian and insect derived cell line 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 / grade B environment fulfilling requirements for primary and secondary gowning and demonstration of excellent aseptic skills
- Responsible for SAP system activities to include generation of new material numbers and data sets, work in progress activities, inventory management, movement of seeds across sites, test article workflow through ZLIMS
- 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).
- Coordinate seed testing protocols and sample submissions with external CROs to support global testing of seeds.
- 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
- Work with cross functional team across the organization to define the production method for each seed, including primary authorship of the production document and subsequent report(s) for government submissions
- 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.)
- 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.
- Ability to develop and maintain effective, trusting work relationships
- Self-starter, able to prioritize work and work efficiently with minimal supervision
- Ability to handle change (changing workloads).
- Good at multitasking with ability to work with deadlines.
Educational Requirements / Experience:
- Bachelor's degree and/or equivalent work experience in a scientific discipline with emphasis in microbiology/biochemistry/medical technology, or related disciplines.
- Experience working with bacteria, virus, and cell lines.
- Experience working in a GLP/GMP environment and/or an understanding of GLP/GMP regulations/procedures is desirable.
- Computer skills required: SAP, Microsoft Word, Excel, and Outlook.