Manufacturing Manager

Position Overview:
This role is a critical position within the organization, focused on executing the company’s short-term production goals and objectives. The Manager of Production Manufacturing is responsible for overseeing departmental activities across all aspects of the tissue manufacturing process, ensuring compliance with local, state, and federal regulations. This position involves supervising production technicians and administrative employees involved in manufacturing, as well as managing tactical manufacturing plans, capacity requirements, and customer standards. The position is located on-site at the company’s Gaithersburg, MD facility.

Essential Duties & Responsibilities:

• Provide leadership across all aspects of tissue processing, packaging, policy development, team training, and regulatory compliance.
• Manage all aspects of tissue processing operations.
• Supervise and lead a team of production technicians, including cross-training within processing teams.
• Ensure adherence to quality control and quality assurance guidelines in tissue processing.
• Collect and analyze report data on tissue processing, procedures, outcomes, productivity, and efficiency to drive improvements and ensure compliance with standards.
• Collaborate with quality assurance teams to ensure quality system requirements for the processing program are met and maintained.
• Work closely with supply chain teams to ensure adequate donor and supply levels are available to meet production needs.
• Perform tasks using Universal Precautions safely in environments with potential bloodborne pathogens (BBP).
• Safely handle materials stored at -80°C and on dry ice, ensuring compliance with safety protocols, SOPs, training, and regulatory standards.

Education & Experience:

• Bachelor’s or Associate degree in life sciences preferred.
• Experience working in a tissue-based manufacturing facility (e.g., allograft).
• Knowledge of tissue donor consent, screening, and recovery processes.
• Familiarity with cGMPs, QSRs, and SOPs.
• Ability to work effectively with interdisciplinary teams.
• Strong interpersonal skills and ability to build relationships based on integrity and collaboration to meet objectives.
• Working knowledge of lean manufacturing and continuous improvement processes.
• Ability to conceive, plan, and implement new processes and procedures, including training staff.
• Ability to select, train, and develop a team to manage a growing range of tasks.
• Skilled in forming internal and external alliances to achieve organizational goals.
• Strong team-building, communication, and organizational skills.