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 daytoday 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
ANIMAL CARE AND WELFARE RESPONSIBILITIES
Develop and implement protocols for the care feeding and housing of pigs to ensure their wellbeing 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
COMPLIANCE AND RECORD KEEPING RESPONSIBILITIES
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
QUALIFICATIONS
DVM or VMD from AVMAaccredited institution
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 problemsolving 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)
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