Kashiv Pharma, LLC. is an emerging pharmaceutical research and drug delivery company focused on developing innovative technologies, improved medicines and life cycle management products. Kashiv also offers contract research and development services to pharmaceutical clients in need of formulation and analytical development expertise and/or clinical supply manufacture.
The company’s mission is to develop the next generation drug delivery platforms, and apply these proprietary technologies to create a portfolio of improved versions of known medicines with meaningful clinical differentiation and a compelling value proposition for patients, physicians, and payers. Kashiv intends to utilize the accelerated regulatory approval process to bring these improved drugs to market faster and more efficiently.
Kashiv aspires to become a world-class premier drug delivery, development, and specialty pharmaceutical company with a portfolio of improved medicines through the use of cutting-edge innovation, proprietary platform technologies, and strategic partnerships throughout the industry.
Essential Duties & Responsibilities
Key responsibilities of the position include, but are not limited to –
• Perform formulation development and optimization based on physico-chemical and biopharmaceutical properties of drug molecules.
• Execute R&D trials to pilot batches, including process optimization of oral dosage form unit operations using FDA’s Quality by Design (QbD) and well-experimental design approaches
• Work proactively with preformulation team for in-depth API solid state and formulation characterization
• Establish optimal process parameters from process development for technology transfer and scale up.
• Prepare master manufacturing records, SOP’s, check lists, and training curriculum for operators on procedures, safety and health systems
• Review executed batch documents as per process strategies and compliance
• Prepare and timely issue high quality product development report and documentations for Clients and regulatory submissions
• Communicate and present development activities, findings and recommendations to the team
Position Requirements and Qualifications
Education and Experience
• In order to perform this array of duties, the employee should have a degree in pharmaceutical sciences, industrial pharmacy, and/or chemical engineering:
o Doctoral’s degree with at least 5-years of experience
o Master's degree with at least 10-years of experience
o Bachelor’s degree with at least 15-years of experience
• Must have hands on experience in setup, operation, trouble shooting of equipments used in oral solid dosage forms
• Is able to independently work and design experimental protocols of the following scope of work:
o Understanding rigorous physicochemical, solid state characterization of APIs and performing formulation research for predictive stability and bioequivalence, including troubleshooting activities to resolve complex issues.
o Executing unit operation of various immediate and controlled release oral solid dosage forms, assuring predictive manufacturing scalability.
• Understand and effectively conduct laboratory experiments utilizing established internal and published procedures.
• Is up-to-date on recent advances of oral drug delivery technologies.
• In-depth understanding drug product development, FDA guidance and c-GMP compliance
Specialized Knowledge and Skills
• Perform due diligence and provide scientific recommendations on formulation strategies
• Attention to details and accurate record keeping
• Is capable of presenting work at both internal and external meetings
• Communicate well verbally with excellent writing and critical analysis skills
• Is capable of managing work independently with efficient utilization of time & resources
• Is sought by peers/others as a source of technical information and respected as a resident expert in formulation development, process optimization and oral drug delivery technologies
Work Environment & Physical Demands
General work environment and physical demands as required to successfully performing the essential functions of this job. Ability to work flexible hours as needed. Some travel may be involved.