Opportunities

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

IMPORTANT SAFETY INFORMATION (United States)

INDICATIONS FOR USE: The RECELL® Autologous Cell Harvesting Device is indicated for the treatment of acute thermal burn wounds. The RECELL® device is used by an appropriately-licensed healthcare professional at the patient’s point of care to prepare autologous RES® Regenerative Epidermal Suspension for direct application to acute partial-thickness thermal burn wounds in patients 18 years of age and older or application in combination with meshed autografting for acute full-thickness thermal burn wounds in pediatric and adult patients.

CONTRAINDICATIONS: RECELL® is contraindicated for: the treatment of wounds clinically diagnosed as infected or with necrotic tissue, the treatment of patients with a known hypersensitivity to trypsin or compound sodium lactate (Hartmann’s) solution, patients having a known hypersensitivity to anesthetics, adrenaline/epinephrine, povidone-iodine, or chlorhexidine solutions.

WARNINGS AND PRECAUTIONS: Autologous use only. Wound beds treated with a cytotoxic agent (e.g., silver sulfadiazine) should be rinsed prior to application of the cell suspension. RECELL® is provided sterile and is intended for single-use. Do not use if packaging is damaged or expired. Choose a donor site with no evidence of cellulitis or infection and process skin immediately. A skin sample should require between 15 and 30 minutes contact with Enzyme. Contact in excess of 60 minutes is not recommended. RECELL® Enzyme is animal derived and freedom from infectious agents cannot be guaranteed.

PRECAUTIONS: RECELL® is not intended for use without meshed autograft for treatment of full-thickness burn wounds. The safety and effectiveness of RECELL® without meshed autograft have not been established for treatment of partial-thickness burn wounds: on the hands and articulating joints, >320 cm2, in patients with wounds totaling >20% total body surface area (TBSA). The safety and effectiveness of RECELL with autografting have not been established for treatment of full-thickness burn wounds: on the hands and articulated joints, and in patients younger than 28 days of age (neonates).

SPECIAL PATIENT POPULATIONS: The safety and effectiveness of RECELL® have not been established for treatment of acute thermal partial-thickness burn wounds in pediatric patients younger than 18 years of age.

For complete Important Safety Information, refer to Instructions For Use. Please be aware that any indication for RECELL® outside of the United States may differ from the US indication. Please see the Instructions for Use for each country for the specific indication of RECELL®.

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©Copyright 2022 AVITA Medical. All Rights Reserved.
Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to AVITA, its subsidiaries or affiliates. No use of any AVITA trademark, trade name, or trade dress in this site may be made without the prior written authorization of AVITA, except to identify the product or services of the company.
©Copyright 2022 AVITA Medical. All Rights Reserved.