Pharming is a global, commercial stage biopharmaceutical company developing innovative protein replacement therapies and precision medicines for the treatment of rare diseases and unmet medical needs. The company is poised for further scientific, technological and new product development and additional commercial roll-outs. The company is based internationally and growing quickly. As a result of this growth, we are looking for a Director Transgenic Platform Support
About the role:
The Director Transgenic Platform Support leads and supervises animal scientists, contributing to the optimal health and welfare of all animals within Pharming. The scope of the function covers the biosecurity of the (SPF) colonies/herds, the breeding, male and female reproduction and zootechnical aspects like housing and feeding. In this respect the Director Transgenic Platform Support sets specifications for animals and animal related products, maintains semen and embryo banks and sign off health certificates on the basis of the microbiological status of the colonies/herds.
The Director Transgenic Platform Support creates and maintains a network of (academical) experts who can be consulted for training purposes or additional scientific support.
The Director Transgenic Platform Support chairs the Animal Welfare Body (IvD and supervises the compliance with the Dutch Act on animal experimentation (Wod)
Areas of responsibilities:
- Animal health and welfare: Set up and monitor a bio security program; control and maintenance of animal health (SPF) status. Prepare and take care of the execution of health management programs. Ensure timely reviews of health screening reports and signing off of health certificates. Take steps in case of health deviations and supervise/verify corrective actions. Write recommendations in case of loss of SPF status and ensures implementation of approved actions. Review and approve facility specifications pertaining to the biosecurity principles of new animal facilities. Supervises animal welfare and act as attending veterinarian according to art. 14 Wod
- Animal products: optimize specifications for animals, germ cells, feed, veterinary drugs and instruments. During commercial production.
- Animal reproduction: control and monitor the stability, quality and availability of semen (MTB and MWTB) and embryo’s to ensure the continuation of the animal platforms. Optimize and monitor breeding strategies, provide recommendations on new transgenic lines and the development of new (SPF) colonies or herds
- Personnel: identify the (scientific) requirements and define roles of employees, select candidates and ensure adequate onboarding education and (continuous) training, organize work force and lead and supervise the team(s) taking into account the career development.
- Basic Quality System: initiate, review and authorize SOPs, Work Instructions, test protocols and – reports related to animal aspects of the rabbit and cattle platform. Ensure timely preparation of change requests, deviations and CAPA’s and ensure these are managed according to defined timelines. Ensure readiness for inspections by authorities
- Dossier: Upon request edit relevant parts of the regulatory dossier and formulate answers to regulatory questions
- Compliance: ensure animals are housed and treated according to relevant (inter)national legislation (EU directive 2010/63, Wod, GMO) and guidelines (e.g. FELASA). Chairs the IvD, nominate members and control proper documentation (e.g. minutes). Manage project applications and changes. Submit yearly registration reports to the NVWA.
Required skills and qualifications in order to be successful in this role:
- Problem Analysis
- Quality orientation
- University degree in animal (veterinary) science or equivalent
- Strong understanding of biosecurity and principles
- Good command of written and spoken Dutch and English
- Adequate knowledge of (inter)national legislation and guidelines with respect to laboratory animals
- Good grasp of principles of colony and herd health and milk production management
- Understanding of GMP principles
- Article 9 WOD certification, including species specific ruminant and rabbit modules
- Minimum of 3 years experience in laboratory animal science
- Minimum of 5 years of experience in managing (multidisciplinary) teams within scientific ( pharma ) industry