Job description

Position Title: Site Lead (Director/VP)

Job Type: Full time
Onsite 5 days a week

Company Background:
Our company is a pioneering organization specializing in drug-eluting biomatrix products, designed to offer physicians the benefits of natural biological materials combined with targeted therapeutics for wound healing. We develop and commercialize biologic products to enhance the compatibility between medical devices and the patients who depend on them. With a growing population needing implantable technologies, our mission is to humanize medicine, ensuring patients can thrive without compromise. At the core of our mission are our patients, and our primary commitment is to their well-being.

Position Overview:
This position is a key leadership role within our team, instrumental in advancing both the company’s long-term mission and its short-term goals. The Site Lead will be responsible for leading the build-out and operationalization of our new manufacturing facility in the Gaithersburg, MD area. Initially, this facility will focus on manufacturing and distributing SimpliDerm, a pre-hydrated human acellular dermal matrix used in soft-tissue repair, including breast reconstruction. Shortly thereafter, the facility will expand to manufacture a drug component for our EluPro product, the world’s first drug-eluting biologic.

The Site Lead will oversee and optimize key operational aspects, ensuring the highest standards of quality in manufacturing while minimizing operational costs and maintaining consistent product supply.

Essential Duties & Responsibilities:
Build-out:

Lead the build-out of the new manufacturing facility in Gaithersburg, MD.
Assist with the hiring and management of the facility’s team, including key roles in manufacturing, quality, process/equipment validation, and donor services.
For SimpliDerm, lead the equipment qualification and process validation for the end-to-end manufacturing process.
For EluPro disc component manufacturing, oversee the tech transfer process, collaborate with external partners, and define and perform process validation.
Design and implement a comprehensive quality management system, including the creation, review, and approval of all documents for both GMP (Good Manufacturing Practices) and GTP (Good Tissue Practices).

Ongoing Operations:

Lead day-to-day manufacturing operations with a hands-on, exemplary approach.
Collaborate with external vendors and suppliers to ensure high-quality, timely services.
Work with the R&D team to transition products from development to production, enabling timely product launches.
Lead production planning efforts, including resource optimization, inventory management, data analysis, equipment maintenance, budgeting, and forecasting.
Identify and drive operational improvement initiatives, including cost analysis to reduce COGS (Cost of Goods Sold) for all products.
Ensure compliance with applicable regulations and standards, balancing GMP and GTP processes for the facility.

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, with increasing responsibilities. Experience in establishing and leading GMP facilities is required.
Direct experience in manufacturing tissue (xenograft or allograft) or drug/device combination products. Experience in establishing and leading GTP manufacturing facilities.
Experience in obtaining AATB (American Association of Tissue Banks) accreditation and passing FDA inspections.
Strong problem-solving skills with the ability to prioritize and align a team towards common goals.
A proactive, results-driven attitude with a commitment to continuous learning and improvement.
Must embody our core values: confident, relentless, and united in purpose.