(Archived) Scientist, Biodevice Development & Validation

POSITION SUMMARY

This Scientist, Biodevice Development & Validation (BDV) position is located at Zoetis Global BioDevices R&D headquarters’ in Durham, North Carolina. This individual will play a role in the development and validation of biodevice products that are on the cutting edge of technology in the global animal health industry to maintain Zoetis Inc. as a global leader in biodevices for livestock and companion animals. The Scientist, BDV will be responsible for contributing and sometimes leading efforts ensuring all Zoetis biodevice products achieve a successful, safe and efficacious, product launch. This role influences design by evaluating bioprocess impacts, contributing to design requirements and specifications for development, and executing the required testing to validate biodevice designs. The Scientist, BDV will be required to coordinate and participate in technical evaluations both in-house and at customer test sites as well as interact with engineering disciplines, Technical Service and Field Service representatives. While a good faith effort has been used to identify duties and responsibilities of this role, the duties and responsibilities are subject to change based on the requirements of the job and the business judgment of the leadership team.

POSITION RESPONSIBILITIES

* Provide product development insight for novel biodevice offerings and their potential impact on biology through research of real world usage parameters that may impact device safety and efficacy.

* Develop and execute testing protocols for characterization and validation of biodevice products and/or concepts at the interface of technology and biology.

* Record, calculate, and maintain detailed records of experimental data in accordance with GLP or GCP.

* Conduct studies to test prototypes; input data into databases, derive reports and analyze data. Perform necropsy and biological analysis as needed.

* Manage projects in support of providing viable solutions to develop and validate biodevice designs.

* Interact with appropriate cross functional groups to coordinate testing both in-house and in the field while maintaining biological integrity. Manage relationships with customers to ensure tests minimize impact.

* Contribute and sometimes lead the efforts for development of device cleaning and sanitation methods through analytical testing. Conduct validation and testing for design changes (ECR’s) of components, device sub-systems, or full bio-mechanical devices, both in-house and at commercial production test sites.

* Identify and document test methods and procedures for newly developed process needs for BDV.

* Provide strong support in problem solving for reported internal and external customer issues due to technology interactions while maintaining biological integrity.

* Ensure that all necessary instruments, tools, and materials are available to support required testing.

* Design, draft, and execute protocols to validate bioprocess functionality, equipment and process validation, durability testing, target animal safety and efficacy and product potency and purity.

* Continuously improve process and/or device performance test documentation including SOPs, validation protocols and data records to ensure device performance remains safe and efficacious.

* Maintain the integrity of central document repository of supporting test plans, procedures, raw data, and results utilized in the development and validation of biodevice products.

* Develop and publish schedules for testing of new devices as required. Include appropriate resources needed to successfully meet establish project timelines.

* Provide scientific expertise for the development and commercialization of applied bio-mechanical technology. Facilitate the handoff/technology transfer of new commercial technology/devices to the Sales and Marketing, Field Service, and Manufacturing Departments.

* Interact with QA, QC, Engineering, Technical Service, Customer Service, and other integral business lines in support of generating and/or updating core device operation requirements/specifications.

* Work with regional Customer Service representatives to support remote validation evaluations of new device components, mechanical sub-systems, software and/or full in-ovo systems.

EDUCATION AND EXPERIENCE

· Bachelor of Science degree in biology or other animal science discipline.

· 3-5 years of relevant animal science experience

· 3-5 years of experience within a device engineering environment.

o Practical and relevant laboratory experience

o Demonstrated hands-on interactions integrating mechanical devices and biological processes

o Experience with poultry preferred

o Medical device development exposure is a plus

TECHNICAL SKILLS REQUIREMENTS

· Capable of developing and executing specification driven test protocols

· Strong interpersonal and communication skills to interact effectively with internal and external customers

· Ability to manage multiple projects and assignments.

· Experience with animal handling and GLP/GCP desired

· Experience with utilizing Lean and Six Sigma principles and tools desired

· Ability to perform research activities involving specialized laboratory equipment

· Ability to interpret experimental results

· Competent in written and oral communication

· Highly proficient with the use of Microsoft Word and Excel

PHYSICAL POSITION REQUIREMENTS

* Standard office working conditions

* Animal health working conditions:

* Projects will require personnel to spend time within commercial livestock environmental conditions and animal healthcare facilities. This will expose personnel to dander particulates, chemical fumes, heavy automated production equipment, biological exposure, and confined spaces. Appropriately defined personal protection equipment (PPE) will be provided to all personnel to comply with customer site and Zoetis internal employee safety and biosecurity policies.

* Lab environment with mechanical and biological/chemical hazards.

* Extensive field work is required (up to 30%) depending upon stage of product testing - subject to adjust based on project requirements.