What are the responsibilities and job description for the Director, GMP Production & Veterinary Services position at eGenesis, Inc.?
Company Mission
At eGenesis, we aspire to deliver safe and effective human transplantable cells, tissue and organs utilizing the latest advancements in genome editing.
Position Summary
We are seeking a highly motivated and experienced Director, GMP Production & Veterinary Services to oversee the daily operations of our DPF/SAF donor facility. You will be responsible for managing all aspects of the facility, ensuring compliance with all relevant regulations and standards, and supporting the transition to clinical trials. In this role, you will both directly and indirectly lead the staff in the GMP Production facility to ensure a reliable drug product supply for eGenesis’ clinical needs. You will also collaborate with Quality, Regulatory and Clinical Operations to produce safe and effective drug products. This role is crucial in maintaining a safe, efficient, and humane environment for both animals and staff.
Facility Management Responsibilities
At eGenesis, we aspire to deliver safe and effective human transplantable cells, tissue and organs utilizing the latest advancements in genome editing.
Position Summary
We are seeking a highly motivated and experienced Director, GMP Production & Veterinary Services to oversee the daily operations of our DPF/SAF donor facility. You will be responsible for managing all aspects of the facility, ensuring compliance with all relevant regulations and standards, and supporting the transition to clinical trials. In this role, you will both directly and indirectly lead the staff in the GMP Production facility to ensure a reliable drug product supply for eGenesis’ clinical needs. You will also collaborate with Quality, Regulatory and Clinical Operations to produce safe and effective drug products. This role is crucial in maintaining a safe, efficient, and humane environment for both animals and staff.
Facility Management Responsibilities
- Oversee the day-to-day operations of the DPF/SAF pig facility, ensuring it runs efficiently and effectively
- Collaborate with architects, engineers, and other stakeholders in the planning and design of new or renovated facilities
- Ensure that the facility complies with all applicable regulatory requirements and industry standards, including biosecurity protocols and animal welfare guidelines
- Ensuring compliance with GMP standards through the monitoring and recording of all work processes
- Accompanying the completion of the SAF and the commencement of operations
- Oversee production of clinical supply, provide facility reports to leadership, and propose risk mitigation strategies as needed
- Oversee the procurement and inventory management of all supplies, including feed, bedding, and equipment
- Ensure all supplies are stored properly and used efficiently to minimize waste
- Develop and implement protocols for the care, feeding, and housing of pigs to ensure their well-being in close collaboration with the Animal Resources Managers
- Monitor animal health and coordinate with veterinarians to address any health concerns
- Manage donor production, monitoring of pregnancy, and care of piglets
- Serving as the Attending Vet, if applicable
- Maintain accurate records of production, and facility operations
- Ensure compliance with all relevant local, state, and federal regulations, including those related to animal welfare, biosecurity, and environmental impact
- Writing and reviewing SOPs
- Prepare for and participate in facility inspections and audits
- Bachelor’s degree in Animal Science, Veterinary Science, or a related field; equivalent experience may be considered
- Minimum of 5 years of experience in animal facility management, preferably in a pig or livestock facility
- Strong knowledge of animal welfare standards, biosecurity protocols, and relevant regulations
- Proven leadership and team management skills
- Excellent organizational and problem-solving abilities
- Strong communication skills, both written and verbal
- Proficiency in using facility management software and maintaining accurate records
- Experience in Pig Husbandry and Care
- Proficiency in facility design
- Certification in Animal Welfare or a related field
- Experience adhering to Good Manufacturing Practices (GMP)
