Director, Manufacturing
Apply NowCompany: Tissuetech Inc. & Subsidiaries
Location: Miami, FL 33186
Description:
About BioTissue & our Culture
At BioTissue, we transform the gift of life by sharing miracles. We are a diverse community, where talent and teamwork are core to who we are. Here, you are EMPOWERED to do the work you love, be yourself, and make an impact. Resilient and committed to our vision, we embrace challenges, celebrate courage, and take great pride in our work to create life-changing products.
Purpose led us here. Passion and legacy keep us going.
Position Summary
We are seeking a dynamic candidate to lead our manufacturing operations, ensuring the efficient production of high-quality human tissue-based products in compliance with regulatory and company standards. This role will be responsible for overseeing all aspects of production, driving operational excellence, and fostering a culture of continuous improvement.
Essential Duties S Responsibilities
Position Expertise/Qualifications
Degree/Diploma: Required
Program of Study: Science related field or engineering preferred.
Certification & Licensures: Six sigma and/or Lean certifications preferred.
Minimum Years of Experience
10+ years of manufacturing experience, with at least 5 years in a leadership role within a regulated industry (biotechnology, pharmaceuticals, medical devices, or tissue-based products).
Skills & Abilities
Travel Requirements
< 5 % of Travel
Total Rewards
Health, Dental, Vision Insurance, 401 (k), FMLA, Health Saving Account (HSA), Flexible Spending Account (FSA), Basic Life and AD&D insurance, Voluntary Life and AD&D insurance, Disability, Employee Assistance Program (EAP), LegalShield / IDShield, Pet Insurance, tuition reimbursement, and Birthing & Parental Leave, Paid Holidays, Paid time off, MBO, Stock options.
ADA Statement
Candidates who cannot perform one or more of these requirements due to disability will be eligible for consideration based on whether the candidate can perform the position's essential functions with reasonable accommodations.
At BioTissue, we transform the gift of life by sharing miracles. We are a diverse community, where talent and teamwork are core to who we are. Here, you are EMPOWERED to do the work you love, be yourself, and make an impact. Resilient and committed to our vision, we embrace challenges, celebrate courage, and take great pride in our work to create life-changing products.
Purpose led us here. Passion and legacy keep us going.
Position Summary
We are seeking a dynamic candidate to lead our manufacturing operations, ensuring the efficient production of high-quality human tissue-based products in compliance with regulatory and company standards. This role will be responsible for overseeing all aspects of production, driving operational excellence, and fostering a culture of continuous improvement.
Essential Duties S Responsibilities
- Operational Leadership & Strategy
- Develop and execute a strategic plan to optimize manufacturing operations while ensuring compliance with regulatory requirements (FDA, GMP, ISO, etc.).
- Oversee day-to-day production activities to ensure efficiency, safety, and high-quality output.
- Establish and track key performance indicators (KPIs) to drive continuous improvement in productivity, quality, cost, and throughput.
- Collaborate with cross-functional teams, including Quality Assurance, Supply Chain, and R&D, to support new product development and process enhancements.
- Team Leadership & Development
- Lead, mentor, and develop the production team to ensure strong engagement, performance, and professional growth.
- Foster a culture of empowerment, accountability, teamwork, and innovation.
- Ensure proper training and development programs are in place for cleanroom operators and production support staff.
- Drive adherence to standard operating procedures (SOPs) and best practices in a cleanroom environment.
- Compliance & Continuous Improvement
- Ensure strict adherence to regulatory guidelines, including Good Manufacturing Practices (GMP) and safety protocols.
- Identify and implement process improvements to enhance efficiency, reduce waste, and optimize production yield.
- Lead investigations and corrective/preventive actions (CAPAs) for any production-related deviations or non-conformances.
- Champion Lean Manufacturing, Six Sigma, or other continuous improvement methodologies.
- Production Planning & Resource Management
- Work closely with Supply Chain to ensure raw material availability and optimize production schedules.
- Work closely with Technical Operations on any facility/equipment maintenance activities to ensure reliable operation and minimize downtime.
- Manage capacity planning and labor allocation to meet production demands while maintaining cost efficiency.
Position Expertise/Qualifications
Degree/Diploma: Required
Program of Study: Science related field or engineering preferred.
Certification & Licensures: Six sigma and/or Lean certifications preferred.
Minimum Years of Experience
10+ years of manufacturing experience, with at least 5 years in a leadership role within a regulated industry (biotechnology, pharmaceuticals, medical devices, or tissue-based products).
Skills & Abilities
- Strong knowledge of GMP, FDA regulations, and cleanroom operations.
- Experience in leading teams in a highly regulated production environment.
- Proven ability to develop and execute strategic initiatives that improve efficiency, quality, and cost-effectiveness.
- Experience implementing Lean, Six Sigma, or continuous improvement methodologies.
- Exceptional leadership, problem-solving, and communication skills.
- Advanced skills with Microsoft programs (Word, Excel, Outlook, etc).
- Familiarity with enterprise systems (ERPs).
- Familiarity with quality management systems.
- Demonstrated success creating scalable processes for rapid growth.
- Demonstrated success with large scale change management.
- Experience with contract manufacturing is preferred.
Travel Requirements
< 5 % of Travel
Total Rewards
Health, Dental, Vision Insurance, 401 (k), FMLA, Health Saving Account (HSA), Flexible Spending Account (FSA), Basic Life and AD&D insurance, Voluntary Life and AD&D insurance, Disability, Employee Assistance Program (EAP), LegalShield / IDShield, Pet Insurance, tuition reimbursement, and Birthing & Parental Leave, Paid Holidays, Paid time off, MBO, Stock options.
ADA Statement
Candidates who cannot perform one or more of these requirements due to disability will be eligible for consideration based on whether the candidate can perform the position's essential functions with reasonable accommodations.