Regulatory CMC Scientist III

Overview

Cook MyoSite, Inc. is on a mission to make regenerative medicine a part of everyday medicine. We’re investigating our core technology, autologous muscle-derived cells, for the potential treatment of several muscle-related disorders. We at Cook MyoSite have the potential to make a difference in the lives of countless people around the world, and we also have the potential to make a difference in yours. Joining our team is an opportunity to ignite your passion, grow your potential, and define your purpose. If you’re curious, motivated by helping others, and driven by integrity, we invite you to apply.

The Regulatory CMC Scientist III at Cook MyoSite Inc. is responsible for providing regulatory guidance, acting as regulatory CMC subject matter expert, and writing and evaluating regulatory submissions and product development and CMC related documentation for cell therapy products.

Responsibilities

• Develop and write content of common technical documentation related to testing and manufacturing, coordinate and manage content for global regulatory submissions, and ensure the maintenance of ongoing regulatory product compliance (e.g. review of change control) • Collaborate effectively across a network of other stakeholders, partners, and customers to deliver high quality regulatory submissions • Ensure regulatory submissions are complete, accurate, and comply with applicable regulatory requirements • Contribute to process design documentation and ensure it meets global regulatory requirements over the lifecycle of the product • Collaborate in cross functional teams to review product lifecycle documentation • Support interactions with health authorities and scientific reviewers as a subject matter expert to facilitate the review and approval of regulatory applications • Support the resolution of CMC information management issues with internal stakeholders • Conduct research and provide analyses of relevant complex regulatory guidance documents, regulations, and directives to inform product development strategy • Assist in material management programs, risk analyses, and/or vendor qualification, as applicable • Assess proposed changes to documentation to ensure consistency with applicable regulatory requirements and need for communication to health authorities • Support review of change controls and quality system documentation to ensure consistency with process design, CMC, and regulatory documentation • Use technical and scientific knowledge to assess risk and develop contingencies appropriate for stage of development and process/operational requirements

Qualifications

• Advanced degree in any relevant life sciences field is required.

• Minimum of 1-3 years' experience in preclinical, CMC, and/or process development in GLP/GMP setting.

• RAC certification is preferred• Experience in common technical document or medical writing. • Knowledge of regulations and guidelines governing biological product development. • Experience with cell and tissue culture and/or relevant technical areas.

• Proficient knowledge of Microsoft Office software, and other general office equipment. • In-depth understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical manufacturing and best practices (e.g. ISPE GAMP). • Proficiency or comfort level working with material of a highly technical or scientific nature.

Physical Requirements:

• Location: Remote / Field Based

• Office Setting (No Travel): General office, warehouse and laboratory setting

• Ability to conduct and hear ordinary conversation and telephone communication. • Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required. • Ability to work under specific time constraints. • Must be able to sit at desk, in meetings and/or work on a computer for long or extended periods of time. • Visual and manual acuity for working with computers and equipment.