COMPANY

CAREERS

iVIEW Therapeutics Inc. is a clinical stage ophthalmology drug development company. iVIEW was incorporated in the State of Delaware in 2015 and is located at Pennsylvania Biotechnology Center of Bucks County, Doylestown, Pennsylvania.

iVIEW Therapeutics is developing a long-acting povidone iodine ophthalmic drop for the treatment of active infections of the conjunctiva and cornea by bacteria, mycobacteria, virus, fungus, or amoebic causes. The lead compound, iVIEW-1201 is an extended release in-situ gel povidone iodine composition which exhibits sol-to-gel phase transitions when instilled into the eye. The effective concentration of povidone iodine is maintained by the equilibrium between the solution and gel bound components resulting in a long lasting anti-viral and antimicrobial effect with less irritation. There is currently no broadly effective therapy that treats all causes of infection and there is no approved treatment for viral conjunctivitis. This represents a massive unmet need in ophthalmology. iVIEW plans to initiate global phase II trials in early 2019 and is currently looking for a self-motivated formulation/CMC expert to join the company. The company will offer Competitive Salary, Health Insurance and Retirement Benefits plus Stock options. If interested, please contact Dr. Bo Liang at bliang@iviewinc.com or Dr. Qi Zhu at qzhu@iviewinc.com.

Position: R&D Director, Product Development- CMC

Location of work: 3805 Old Easton Road, Pennsylvania Biotechnology Center of Bucks County, Doylestown, PA (Research & Development)

Responsibilities:

• Perform literature and patent search to support studies for development of drug products and generate data/development reports as part of regulatory submissions or patent filings

• Plan, perform and lead various stages of product development, including pre-formulation, formulation development, process development, optimization, scale-up studies/technology transfer

• Incorporate Quality-by-Design tools in drug development. Develop prototype formula and evaluate the predetermined QTPPs and CQAs, and continue to improve the formula to reach the development goal

• Write and review GMP documentation, including manufacturing batch records, and appropriate study protocols, and lead project-specific clinical manufacturing

• Lead team members to meet timelines for drug product delivery and lead in working out investigation plans related to manufacturing investigations as required

• Lead and collaborate with CROs to facilitate transfer of knowledge and deliverables of drug product

• Follow company policies and conduct work according to appropriate iVIEW SOPs and comply with cGMP guidelines

Requirements:

• PhD. in Pharmaceutics, Chemistry, or Chemical Engineering, with 5-20 years of experience, or Master’s with equivalent experience

• In-depth knowledge of theory and techniques in pharmaceutics and drug delivery

• Solid knowledge in product development and manufacturing per cGMP compliant procedures, as well as for IND and NDA

• Familiar with FDA CMC regulatory documentations

• Hands on experience in product development including solution, suspension, and/or semisolid products.

• Strong written and verbal communication and presentation skills

• Good understanding of regulatory stability requirements, including FDA/ICH guidance in regards to drug development

Pennsylvania Biotechnology Center at Bucks County
3805 Old Easton Road
Doylestown PA 18902 USA
Copyright © 2019 iVIEW Therapeutics, Inc. All rights reserved.