Director of Cell Therapy Research & Product Development

• - Research and Development
• Irving, TX, USA
• Full Time
• Medical, Dental, Vision, 401K, and PTO Package

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 cell-based therapeutic products in the US for orthopedic and auto-immune diseases.

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 regenerative medicine, immunology, 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 development of 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.

• Minimum 7+ (MS)/5+ (PhD) years of experience in cell therapy product development, including experience with adherent cell lines.

• Experience leading the development of 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.

Location:

• Irving, TX (Onsite position)