Principal Scientist, Protein Biochemist
Primary Function
The Principal Scientist, Protein Biochemist is a key contributor to AVITA’s scientific program focused on driving pipeline development efforts and exploration. Working with a cross-functional team, the Principal Scientist, Protein Biochemist will lead strategy and execution of protein/small molecule identification and biological characterization efforts to support discovery programs and new product development, leading to FDA filings and patent applications.
Duties/Responsibilities
- Hands-on design and execution of biochemical assays to support lead generation for regenerative platform discovery programs (proteins and small molecules)
- Characterize protein kinetics and impact on biological activity at cellular and tissue level
- Assist in the strategy and execution of preclinical research for inclusion in regulatory submissions, including preparation of protocols, reports, and presentations for FDA interactions
- 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
Departmental Management
- Drive departmental project prioritization, time management, and workload management activities
Special Knowledge/Skills
- Advanced knowledge of protein biochemistry, enzymatic reactions and kinetics, mammalian cell biology
- Experience with protein analytics and biologics discovery from concept to FDA filing
- Understanding of recombinant protein development and manufacturing
- Ability to lead pre-clinical animal studies including protocol development, execution, data analysis and interpretation, and publication
- 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
- Enzyme characterization and biological impact experiments
- Project leadership
- Scientific writing (study protocols, study reports, abstracts, posters, and manuscripts)
Education/Training
- Advanced degree in scientific discipline with 7+ years experience
- Strong expertise in biologics characterization with deep understanding of enzyme kinetics
- 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