The Advanced Regenerative Manufacturing Institute (ARMl)IBioFabUSA is a Member-based non-profit, member-driven, public-private partnership with a mission to advance the bioeconomy and transform the future of human health. ARMI provides technical and wrap-around commercialization services to companies seeking to advance technologies that will contribute to this impact.
The Impact That You Will Make
The growth and development of our operational capabilities is critical to our success. You and your team will assist in the development, optimization, and implementation of pre-GMP and Phase 1 GMP-stage manufacturing processes for cells, tissues, and organs. In this role, you will interact directly with external partners, program management, technical operations, quality, and other stakeholders to enable the successful delivery of programs. Reporting to the Senior Director, Operations, you will be responsible for leading a team and implementing best practices for procurement, warehouse and materials management, equipment control, and facilities support for ARMI's 540 N. Commercial St. You will be responsible for building and growing a world-class Supply Chain and Facilities team. You will also lead a 5,000 sqft fit up effort to add additional capacity to the existing facility.
Your Role
Lead procurement, materials management, shipping and receiving, facilities, and equipment maintenance personnel to ensure the successful execution of programs
Develop, coach, and mentor Operations Support team, peers, and stakeholders in Supply Chain and Facilities best practices
Author, Approve, and guide the Operations Support team in technical writing, specifically QMS SOPs and Deviations
Define, track, and utilize key performance indicators (KPIs) for supply chain and facility operations to drive operational success
Administer IT systems, including Monnit equipment monitoring platform, Prendio Procurement, Tridium Building Management, and support Rockwell PharmaSuite MES implementation
Manage facility utility systems and equipment in partnership with landlord to maximize facility uptime
Provide hands on support to equipment and facilities maintenance as needed
Support the Quality Assurance team with validation efforts for Phase 1 GMP manufacturing
Support the implementation of the SIOP process by owning all facets of inventory planning and partnering with Process Development team on capacity (equipment, personnel, and facility) planning
Provide continuous improvement leadership, specifically prioritization of identified opportunities and lean tool deployment
Your Skills and Experiences
Experience leading teams in a Research and Development focused environment
Team leadership experience in a GMP-certified, multi-product CDMO
Demonstrated ability to mentor and provide career growth to direct reports
Demonstrated ability to develop and implement strategic objectives aligned to an organization's mission
High energy, commitment, initiative, and perseverance
Minimum of 10 years of relevant operations, supply chain, and facility management experience in the biopharmaceutical industry
Strong materials management background with a working knowledge of budget management, procurement, and basic accounting principles
Proven ability to lead teams through change successfully and adjust plans, as needed, to achieve strategic objectives
Six Sigma Black Belt or equivalent, demonstrated continuous improvement successes preferred
Engineering background or equivalent years of problem-solving experience strongly preferred
Commitment to quality, scientific integrity, and company mission
Strong analytical and proactive problem-solving skills with a strong attention to detail
Excellent written and verbal communication abilities
Ability to work independently and manage competing priorities
Team-oriented mindset with collaborative cross-functional approach
Ability to work on feet for extended periods and lift up to 50 lbs, including occasional overhead lifting, is required.
By applying, I understand that any offer of employment is contingent upon the successful completion of a background check, in accordance with applicable laws.