Product Development Lead

Company Description Memsel is dedicated to developing phage-based solutions that support a healthier world, with a focus on innovative applications in biotechnology and life sciences. The company works at the intersection of microbiology, molecular biology, and product development to address pressing health and environmental challenges. Team members collaborate in a science-driven environment that values rigorous research, practical impact, and ethical innovation. Memsel offers opportunities to contribute to meaningful products that can improve outcomes across industries and communities.

Role Description The Product Development Lead is a full-time, on-site role based in Fort Worth, TX, who plays a central role in advancing Memsel’s novel wound‑care medical device platforms from early-stage development into scalable, GMP-ready manufacturing. This individual will guide product development activities, coordinate cross-functional execution, and serve as a key interface between R&D, Engineering, Manufacturing, and Quality functions.

This role is ideal for a highly organized, hands-on technical leader who thrives in fast-moving environments and excels at building development structure, driving accountability, and delivering manufacturable products.

Roles and Responsibilities

Product Development Leadership

• Lead cross-functional product development activities from concept through GMP scale-up, ensuring technical alignment, documentation completeness, and readiness for transfer to Manufacturing.
• Partner closely with R&D and Engineering to define product requirements, performance specifications, critical quality attributes, and design-for-manufacturing considerations
• Translate development goals into structured workstreams, deliverables, and timelines to ensure transparency across teams.

Manufacturing & Process Interface

• Support tech transfer activities, scale-up planning, and incorporation of custom-built or complex manufacturing equipment.
• Collaborate with Manufacturing leadership to ensure that early-stage processes mature into robust, controlled GMP operations.
• Contribute to development, authorship, or review of batch records, process instructions, protocols, and validation documents.

Cross-Functional Coordination

• Serve as a key operational bridge between R&D, Engineering, Manufacturing, and Quality to ensure integration of technical, quality, and regulatory requirements.
• Facilitate regular technical alignment meetings and ensure decision tracking, risk identification, and issue escalation.

Quality & Compliance Support

• Ensure development activities align with FDA, EU, and ICH GMP expectations.
• Support deviation investigations, corrective and preventive actions (CAPA), and structured problem-solving work.
• Maintain comprehensive development documentation and support readiness for audits and regulatory interactions.

Continuous Improvement & Technical Ownership

• Lead root-cause investigations and drive continuous improvement initiatives across development programs.
• Evaluate new materials, processes, and technologies to improve manufacturability, product performance, and scalability.
• Champion a high-accountability, data-driven development culture.

Qualifications

• 3 years of experience in GMP manufacturing, R&D, or process development roles within Pharma, Biotech, or Medical Device organizations
• Experience with solid or liquid dosage forms, specialty materials, or device/drug combination products
• Demonstrated leadership experience in regulated technical environments
• Hands-on experience with tech transfer, scale-up, or introduction of custom/complex equipment
• Strong understanding of FDA, EU, and ICH GMP requirements
• Excellent communication and cross-functional collaboration skills
• Experience with QMS systems, deviation management, and structured problem solving
• Background in medical devices, biomaterials, polymer processing, or compounding
• Experience establishing new production lines, pilot manufacturing suites, or early-scale development operations
• Familiarity with statistical process control, optimization techniques, or manufacturing data analytics

Compensation and Benefits

Full-time position; salary or hourly rate as determined by company policy.

Benefits include medical, dental, life insurance, etc.

Must be authorized to work in the United States.

Equal Opportunity Employer; reasonable accommodations available.

Compensation/ Salary Range: $90-100k