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Director of Cell Therapy Research

3 months ago

Irving, Texas, United States Signature Biologics Full time

Director of Cell Therapy Research & Product Development

Signature Biologics, as part of a suite of emerging biotechnology and research companies, focuses on the development and commercialization of regenerative-based products. We have significant clinical experience working with human perinatal biologics internationally and we are currently developing products in the US.

We are seeking a highly skilled Director of Cell Therapy Research & Product Development to join our team and lead the development of cutting-edge cell therapy products, particularly focusing on allogeneic human umbilical cord-derived mesenchymal stem cell (hUC-MSC) based therapies. The ideal candidate will have a strong background in cell therapy research & product development, quality by design, experience with adherent cell lines, bioreactor scale-up/out technology implementation, and the ability to establish internal drug product development capabilities to support nonclinical and clinical studies during each phase of clinical development.

Essential Duties and Responsibilities:

Lead the planning, execution, and management of cell therapy product development programs from preclinical to commercial stages, with a focus on allogeneic hUC-MSC-based therapies. Lead drug substance/product formulation, product/process development, and manufacturing strategies for scale-up/out for allogeneic hMSC-based cell therapies using bioreactor-based technologies. Significantly contribute to CMC development to support phase-appropriate IND filings to support clinical development and ensure alignment with corporate goals Incorporate Quality by Design (QbD) principles where applicable to optimize cell therapy development processes, CMC development, and technology transfer to cGMP manufacturing throughout the product development lifecycle. Support drug product development for other modalities as needed. Collaborate closely with cross-functional teams including manufacturing, regulatory affairs, quality, and clinical operations to develop and execute comprehensive development plans. Provide strategic input into phase-appropriate IND development of cell therapy, ensuring scientific rigor and compliance with regulatory requirements. Mentor and guide junior staff, fostering professional growth and development. Establish internal drug product development capabilities to support nonclinical and clinical studies across different therapeutic modalities. Manage priorities and timelines effectively while identifying opportunities for intellectual property (IP) development

Education and Workplace Requirements:

Master's or PhD degree in Life Sciences, Bioengineering, or related field. 7+ (MS)/5+ (PhD) years of experience in cell therapy product development, including experience with adherent cell lines. Experience leading drug product formulation, process development, and manufacturing for allogeneic hMSC or adherent-based cell therapies. Bioreactor experience in the development of cell therapies Strong understanding of drug development processes and regulatory requirements. Knowledge of cGMP/GLP/GCP regulations and guidelines. Proficiency in project management and ability to prioritize tasks effectively. Excellent communication and collaboration skills. Proficiency in Microsoft Office suite (Word, Excel, PowerPoint, Outlook).

Desired Attributes:

Strategic thinker with strong decision-making skills. Leadership abilities with a collaborative approach. Detail-oriented with a commitment to quality and compliance. Proactive problem solver with adaptability to changing priorities. Commitment to professional growth and staying updated with industry advancements.

Physical Requirements:

Ability to lift 50 lbs. and work in a controlled space laboratory environment. Ability to climb ladders to reach high sampling sites. Ability to reach above the shoulder and bend to be able to gown. Ability to wear full level 3 gowning for extended periods to support EM monitoring in Cleanrooms. Must be able to work while standing for extended periods.