Biotechnology & Laboratory, Project Management & Quality Assurance, Sales & Business Development
COOK MYOSITE INCORPORATED, a division of Cook Incorporated, is a growing, forward-thinking biotechnology organization seeking a full time Regulatory Support Scientist (CMC) to research all CMC aspects of commercial manufacturing and pharmaceutical requirements, as applicable to biologics. This individual will independently write technical sections to support CMC development and will serve as a resource for the Regulatory Affairs Department for interpreting and applying global CMC regulatory requirements.
Essential Job Functions/Duties
Prepares and coordinates the preparation of CTD Module 3 to support marketing approval of cell therapy product.
Applies in-depth understanding of global regulatory requirements, industry standards, and government agency best practices, to prepare regulatory submissions, product quality reviews, or other documents.
Researches and utilizes information from source documentation including records, reports, protocols, to author documents in a uniform style and language for regulatory compliance.
Participates with project teams to coordinate the authoring, review, and finalization of CMC documents in accordance with submission timelines.
Provides detailed and critical review of technical reports generated by product development teams and other internal/external resources, for completeness, accuracy, and compliance with regulations.
Keeps current with changes in regulatory legislation and guidelines and assists in development of strategies to ensure continued compliance.
Assists in development and review of analytical method and process design and validation activities.
Assists in reviewing quality system change controls for regulatory impact, when necessary.
Assists in writing and reviewing internal investigations.
Minimum Work Experience/Educational Requirements
M.S. degree with 5+ years of direct CMC experience or a Ph.D. with 2+ years of relevant work experience, in biopharmaceutical industry, biologics and cell therapy experience preferred.
In-depth understanding of US and global regulatory requirements governing aspects of biologic product manufacturing.
Experience writing tech transfer documentation preferred.
Presents clear, concise, well-organized reports with minimum guidance.
Ability to work independently, prioritize, coordinate and complete multiple projects within deadline while maintaining high level of attention to detail.
Excellent problem solving skills and ability to work with minimal supervision.
Experience working with consultants preferred.
Cook Myosite offers a handsome benefits package which includes Competitive Salary, Health/Dental/Vision Coverage, Company Paid Life Insurance, Company Paid Short Term Disability, Paid Time Off upon hire, Paid Holidays upon hire, 401(k) Eligibility upon hire, Profit Sharing, Company Incentive Bonuses, and an Educational Assistance Program.
Please note that resumes sent without a cover letter and salary requirements will not be considered.
“We are proud to be an equal employment opportunity employer for minorities, women, protected veterans, disabled individuals, and any other protected class.”