R&D Scientist I

We are seeking an R&D Scientist for our client in Belgrade, MT.

The R&D Scientist will help initiate, develop, and implement both research and product development projects to generate new product platforms, products and line extensions. These objectives will encompass the following activities: assist in evaluating new technologies and processes, assist in identifying, developing, and validating test methods, design for manufacturability, project management, design control, risk identification and mitigation, maintain a high level of regulatory and product knowledge, help maintain regulatory compliance, and help ensure department activities conform with company QMS. This position will work within the Research and Development Department, and cross-functionally with other departments as each project or task requires. This position reports to the Director, Process Engineering.

Duties and Responsibilities

* Develop and maintain an understanding of the requirements of the applicable standards and regulations including, but not limited to, 21 CFR 820, 21 CFR 1271, AATB, MDSAP (per jurisdictional requirements), and ISO 13485. Adhere to and promote compliance with the applicable standards and regulations throughout the company
* Support Xtant Medicals mission, values, and Quality Policy
* Maintain a clean and safe working environment at all times and follow requirements to properly dispose of hazardous and non-hazardous waste according to OSHA regulations and Xtant Medical SOPs
* Develop and maintain an understanding of the Xtant Medical products and general biological and chemical systems utilized within the Department.Know how the activities performed in the Department are controlled by and interact with the Quality System and how they affect the production of medical devices and tissues as applicable
* Adhere to Xtant Medical Standard Operating Procedures (SOPs), Good Documentation Practices (GDP), and safety protocols
* Complete annual SOP review and OSHA safety training as applicable
* As part of a team, initiate, develop, and implement both research and product development projects to generate new product platforms, products, and line extensions
* Perform risk assessments and develop FMEAs
* Design and execute complex lab and outsourced animal studies as needed
* Manage R&D projects to meet design, budget, and timeline goals as needed
* Perform design verification and validation and test design and validation for R&D projects. Execute design transfer activities and assemble DHFs
* Perform process validation activities in preparation for manufacturing
* Perform cell culturing and cell cryopreservation
* Work with Facilities Engineering to test new production equipment, help to perform validations, and develop the appropriate documentation
* Perform sterilization validation, shelf-life testing, packaging validations, and supplier evaluations
* Write and/or revise SOPs, Work Instructions, Forms, Protocols, Reports, and other documentation
* Own, maintain, and report to Department Director on financial and schedule impact of prospective, in-progress, and completed projects
* Work to investigate and process CAPAs and Non-Conformances in a timely manner as assigned

Job Requirements

Education/Credentials Experience & Training

* Bachelors degree or higher in an Engineering or Science field is required. Degree in biology, chemistry, microbiology, biochemistry, or bioengineering is preferred
* Zero (0) to two (2) years experience with aseptic processes & GxP regulated environment is preferred
* Experience with stem cells, Medical Devices and/or Tissue Banking is preferred
* Must be willing to acquire Certified Tissue Bank Specialist (CTBS) certification

Technical Requirements/Skills

* Knowledge of current Good Manufacturing Practices (cGMP) and Quality System Regulation (QSR)
* Experience with cell culturing, molecular biology techniques, and cellular cryopreservation
* Ability to design, plan and execute lab and animal studies, and provide sound interpretation of results
* Ability to design and validate test methods
* Understanding of design controls; ability to plan and execute Design V&V and Design Transfer for several different device types desired
* Knowledge of FDA and ISO regulations and standards required; knowledge of AATB standards preferred

Working Conditions

* Office hours: Monday-Friday 8am-5pm, will require frequent weekend/evening work at times during the course of a project

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