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
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
Strong technical writing skills and experience writing quality scientific/technical reports
Computer skills: Microsoft Word, Excel, and Outlook
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