Manager/Senior Scientist - Master Seed Facility

Role Description

The manager of the Master Seed Facility plays an essential role in the progression of Zoetis biological and biopharmaceutical Master and Working Seed / Cell Stocks for global registration in compliance with USDA, EP and FDA guidelines. production of master seeds and master cells required .reports for global registration of new seeds and extension of seed registrations into additional countries.The position is based in Lincoln (Nebraska, USA) with frequent interactions with colleagues and external partners located around the globe.

Position Responsibilities:

• Manage the personnel and facility activities of the master seed facility in compliance to current GMPs for the production of new seeds and cells required for global registration of new biopharmaceutical and biological products
• 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 / gradeB 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
• 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
• 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 global submissions
• Working knowledge of International Biosafety Committee requirements and USDA permit requirements for handling of live infectious materials.

Organizational Relationships:

• The position is located in the Master Seed Facility, Lincoln, NE within the Development Science and Technology group of Zoetis' Veterinary Medicine Research and Development organization.
• The manager will interact with peers and colleagues working in disciplines that include mAb registration pilot lab, biological pilot lab, cell line development, upstream development, quality operations, and regulatory affairs.
• As a manager, this individual will work with other leaders within research and development to support strategic initiatives and project related advancements.
• Interaction with colleagues working in regulatory affairs for global dossier preparation and defense.
• The individual is expected to form collaborative working relationships with project team leaders and line representatives within team settings.
• The position may also interact with external parties including vendors, contractors, research collaborators, and contract manufacturers
• Education and Experience:
• PhD or MS in a Biochemistry, Molecular Biology, Biotechnology, Cell Biology, chemical or biochemical engineering, or a related discipline. The successful candidate would be expected to have 0-2 years of experience with PhD or 15 years experience with MS.
• Extensive knowledge in key disciplines including master seed / master cell banking, understanding of the regulatory testing requirements for testing and subsequent registration of master seed / master cells for global products.
• Experience writing regulatory submission quality scientific / technical reports.
• Management experience demonstrating excellent organizational capabilities, people skills, and facility operations. Past experience in managing people is desirable.
• Experience with cGMPs, inspection, and compliance within a GMP setting.

Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume.

Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search.