Endovac Animal Health · 2 days ago
Lab Director
Endovac Animal Health is a company dedicated to providing premium animal health products with integrity. They are seeking a Lab Director responsible for scientific, technical, and regulatory leadership in commercial biologics manufacturing, ensuring compliance with regulations and quality standards.
Responsibilities
Provide scientific and technical oversight for all laboratory testing and methodologies
Ensure full compliance with CVB-APHIS and state regulatory requirements
Approve new test methods, instrumentation, validations, and performance characteristics
Oversee and evaluate the laboratory’s Quality Management Program
Participate in and lead regulatory inspections and maintain accreditation
Review and approve Standard Operating Procedures (SOPs)
Provide high-level interpretation of laboratory test results
Ensure the competency of laboratory personnel; authorize hiring and training standards
Lead scientific strategy, risk mitigation, and long-term technical planning
Maintain responsibility for laboratory safety and compliance with applicable regulations
Serve as the laboratory’s official regulatory contact and signatory for compliance documents
Direct Laboratory staff in production processes including fermentation, formulation, & final fill
Grow, process, and maintain various bacterial, fungal, and assorted cultures for production
Decontamination and sterilization of manufacturing equipment and spaces before and after use
Operation of calibrated measurement equipment, including scales, thermometers, and pipettes
Directing and setting up animal house Quality testing, record keeping, and disposition
Daily monitoring of environmental control equipment, cold rooms, refrigerators, and incubators
Perform semi-complex QA analysis of various final products and intermediates including UV/VIS spectroscopy, sterility, western blot analysis, various immunological assays, etc
Reporting of abnormalities and deviations in a timely manner
Directing in safety inspections, internal audits, and continuous improvement projects
Maintain the cleanliness and organization of the laboratory storage locations
Direct PPE levels at various production access locations
Maintain the ERP Production Orders, BOM’s, & Inventory controls program
Direct process and equipment monitoring and troubleshooting CAPA investigations
Qualification
Required
Bachelor's degree, MD, PhD, or Doctorate
3-5 years of experience in wet lab/manufacturing leadership, preferably in a pharmaceutical or GMP environment
Extensive knowledge of regulatory and accreditation standards
Strong leadership, communication, and decision-making skills
Ability to follow PRDs, SOPs, and Company/Corporate/Regulatory Policies and Standards
Demonstrate ability to work effectively with team members and show initiative to support and/or train other employees
Excellent interpersonal, communication, problem solving and organizational skills
Strong aseptic technique/cleanroom experience, routine analytical procedures, maintaining microbiological cultures
Work independently on routine tasks with effective time management to meet deadlines
Occasional heavy lifting or moving required
Strong written and verbal skills
Proficient computer-based system skills including PC and Mac
Must Be legally authorized to work in the United States without restriction
Must be willing to take a drug test and post-offer physical (if required)
Must be 18 years of age or older
Preferred
Biotechnology experience
CVB-APHIS Regulatory experience
ISO 9001:2015 Compliance experience
Laboratory Inventory supply management and production forecasting experience
Company
Endovac Animal Health
Veterinary Biotechnology company involved in research, manufacturing, distributing and marketing vaccines in animal health.
Funding
Current Stage
Early StageRecent News
EIN Presswire
2025-08-18
2025-04-01
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