Manufacturing Site Head - GQR : Job Details

Position Title: Manufacturing Operations/Site Lead (Senior Director/ED/VP)

Company Background:

Our company is at the forefront of developing innovative drug-eluting products that combine the wound healing benefits of natural biological materials with the power of targeted therapeutics. We specialize in biologic products designed to improve the compatibility of medical devices for patients.

Position Overview:

This position is a key leadership role within the company, directly contributing to the achievement of both long-term and short-term operational goals. The Site Lead will be responsible for overseeing the build-out and operationalization of a new manufacturing facility located in the Gaithersburg, MD area. Initially, this facility will focus on the production of a human acellular dermal matrix used for soft-tissue repair. Following this, the facility will begin the manufacturing of a drug component for a cutting-edge drug-eluting biologic product.

The Site Lead will be accountable for leading operations, ensuring the highest standards of quality, improving operational efficiency, and maintaining a consistent product supply.

• Lead the establishment of the new manufacturing facility in the Gaithersburg, MD area.
• Support the recruitment and management of the facility's team, including key hires for manufacturing, quality, process validation, and donor services.
• Oversee equipment qualification and process validation for the end-to-end manufacturing of the human acellular dermal matrix.
• Lead the tech transfer process for the drug component manufacturing, including collaboration with external partners, process validation, and the launch of production.
• Manage daily manufacturing operations with a hands-on approach, leading by example.
• Identify and lead continuous improvement initiatives to reduce operational costs and decrease the cost of goods sold (COGS).
• Ensure compliance with all applicable regulations and standards, balancing the requirements of GMP and GTP processes.

Education & Experience:

• Bachelor's degree in life sciences, engineering, operations, or a related discipline.
• 8+ years of experience in drug and/or medical device manufacturing roles with increasing responsibility, including experience leading GMP facilities.
• Direct experience in manufacturing tissue-based products (xenograft or allograft) or drug/device combination products.
• Experience with GTP manufacturing facilities is required.
• Experience obtaining AATB (American Association of Tissue Banks) accreditation and passing FDA inspections.

Executive

Full-time

Manufacturing and Project Management

Pharmaceutical Manufacturing and Biotechnology Research