The Head of Operations is a pivotal role within StimLabs, responsible for overseeing daily operations and ensuring the seamless functioning of business processesthat support the manufacture of transplantable products and medical devices derived from human cells or tissues (HCT/Ps).
Essential Duties And Responsibilities
- Developing and implementing short/long-term operational strategies supporting the company’s mission to innovate with purpose and transform lives through regenerative science
- Leading and motivating teams responsible for the timely manufacture and packaging of sterile products, as well as batch record analyses, ensuring adherence to regulatory standards (safety, quality, and cost) throughout each process
- Analyzing and improving operational processes, identifying opportunities for efficiency and cost reduction, and ensuring smooth workflows
- Coaching and developing direct reports and staff, fostering a culture of excellence and continuous improvement.
- Collaborating with other departments and stakeholders to ensure alignment, facilitate communication, and support the timely execution of team duties
- Collaborating with R&D to assist in the initial design and ultimate technology transfer of new products to a regulated manufacturing environment
- Managing department budget to ensure adherence to annual/monthly targets and capital expenditure estimates
- Establish and track key performance indicators to measure the efficiency and effectiveness of operations
- Performs all duties of an Operations Manager or Supervisor when needed
- Perform other duties assigned by StimLabs management
Minimum Qualifications (Knowledge, Skills, And Abilities)
- Minimum 15 years of experience in manufacturing, biotechnology, tissue processing, or aseptic processing
- Minimum 10 years progressive experience leading, directing, and being responsible for the work of others
- Experience working in an AATB and/or FDA-regulated facility preferred
- Supply chain experience preferred
- Proven ability to lead, motivate, and develop teams
- Familiarity with industry best practices and relevant regulations
- Demonstrated ability to solve problems and make decisions
- Strong communication and organizational abilities
- Proficiency wth ERP systems, Lean/Six Sigma tools, and data analysis platforms preferred
- Bachelor of Science or equivalent