Principal Scientist (Irvine)
Primary Function
The Principal Scientist is a key contributor to AVITA’s scientific program focused on driving pipeline development efforts and exploration focused on full-thickness skin reconstruction. Working with a cross-functional team, the Principal Scientist will lead execution of pre-clinical programs to support discovery and new product development, leading to FDA filings and patent applications.
Duties/Responsibilities
- Assist in the strategy and execution of preclinical research for inclusion in regulatory submissions, including preparation of protocols, reports, and presentations for FDA interactions
- Hands-on design and execution of pre-clinical studies including benchtop assays and small and large animal studies focused on skin regeneration
- Process and analyze datasets and interpret results
- Active engagement with project team members from various cross-functional teams (Program Management, Regulatory, New Product Development, Operations, Clinical Affairs)
- Establish and maintain relationships with contract regulatory consultants, research organizations, and academic partners
- Assess and implement new technologies and protocols to existing workflow to improve laboratory capabilities and efficiency
- Stay abreast of current scientific trends, opinions of company data, and that of complimentary and competitive products
Special Knowledge/Skills
- Advanced knowledge of skin cell biology, extracellular matrices, biological dressings, wound healing, and pigmentary disorders
- Ability to lead pre-clinical including protocol development, execution, data analysis and interpretation, publication, and FDA submission
- Effective project and resource management skills
- Excellent written and oral communication skills with proficiency in Microsoft word and PowerPoint
- Experience with DOE and statistical analyses
- Knowledge of aseptic technique, blood borne pathogens, and GLP
Experience
- Strategy and execution of preclinical development plan to support FDA filings
- Cell culture
- Small and large animal studies
- Scientific writing (study protocols, study reports, abstracts, posters, and manuscripts)
Education/Training
- Advanced degree in scientific discipline with 3+ years experience
- Experience with mammalian cell culture and cellular functions, experience with skin biology desired
Travel Expectations
- Up to 20% travel may be required for conference attendance and in-person corporate meetings
Position Location
- Irvine, California
Information Security Compliance
AVITA Medical recognizes the role of information security in ensuring that users have access to the information they require to carry out their work in a secure manner. AVITA Medical is committed to protecting the security of its information and information systems. As such, each role within AVITA Medical must demonstrate the same commitment to information security.