Position Overview:
This position is a key member of the Elutia team and as such is involved in executing the Company’s short- term goals and objectives as it relates to production. This position is responsible for the management of departmental activities in all aspects of the tissue manufacturing process in accordance with local, state, and federal statutes and regulations. Supervision is exercised over processing techs and administrative employees with assigned responsibilities in manufacturing. This position manages the tactical manufacturing plans, capacity requirements, and ensures customer standards are met. This position will be located on-site in the Company’s Baltimore, MD facility.
Essential Duties & Responsibilities:
· Provides leadership for all aspects of tissue processing, packaging, policy and procedures, team development and regulatory compliance.
· Manages all aspects of tissues processing operations.
· Manages team of production technicians; leads cross-training within processing teams.
· Ensures all quality control and quality assurance guidelines associated with tissue processing are in place and met.
· Assists in collecting report data and statistics related to tissue processing, procedures, outcomes, productivity, efficiency, and related areas with the goal of improving processes and compliance to applicable standards.
· Works closely with quality assurance staff to ensure that quality system requirements are met and maintained for the processing program.
· Works closely with supply chain personnel to ensure adequate levels of donors and supplies are available to meet requirements.
· Ability to perform duties using Universal Precautions competently and safely in the presence of potential bloodborne pathogens (BBP).
· Safely handle materials stored at - 80°C and on dry ice. Performs tasks and ensures that others perform tasks in a safe manner in compliance with all current Elutia SOPs, training, and safety policies and applicable regulations.
Education & Experience:
· Bachelors or Associate Degree in the life sciences preferred.
· Must have experience working in a tissue-based manufacturing facility (allograft) · Knowledge of tissue donor consent, screening, and recovery
· Knowledge of cGMP’s, QSR’s and SOP’s
· Ability to work well with interdisciplinary teams
· Ability to maintain effective working relationship and establish the highest level of integrity with others to coordinate work in order to meet objectives
· A working knowledge of lean manufacturing and continuous improvement processes
· Ability to conceive, plan, provide training for, and implement major new processes and procedures.
· Ability to select, train, and develop a team capable of carrying out a continuously increasing range of delegated tasks.
· Ability to form alliances both internal and external to the company to achieve the company’s goals.
· Excellent team building, communication, and organizational skills.
