Senior or Principal Formulation Scientist - Nasal and Inhaled Product Development
Date posted: February 22, 2023
Kenox Pharmaceuticals Inc. is an emerging pharma company focusing on the development and testing of highly innovative aerosol-based drug-delivery products for the eye, nasal, oral and inhalation applications. We have an exciting opportunity for Senior and/or Principal Scientists to join our fast-growing organization to support in the development of Orally Inhaled and Nasal Drug Products (OINDPs). The candidate will be responsible for the development and testing of intranasal and inhaled products (soft mist inhalation, nebulization, and DPIs) of small as well as large molecules, based on highly innovative device technologies, leading to successful preIND meetings, IND and NDA/ANDA filings and approval in a timely manner. Proven industrial experience in the development of OINDPs is highly desired. Experience with formulation development and testing of biomolecules such as peptides, therapeutic proteins and vaccines is preferred.
- Conduct pre-formulation studies including solubility, compatibility, and stability studies (iterative as well as ICH conditions)
- Designing and hands-on formulation/process development and analytical testing (for various drug delivery systems based on QbD from project initiation to the target goal or commercialization.
- Manages and maintains R&D labs. Ensures safe and effective operations and product development in a timely manner.
- Serving as the primary author of product development reports, technical reports/summaries independently, including but not limited to:
- Generating accurate, reliable data by following established procedures and practices for product development; Record, tabulate, summarize and report results.
- Interpreting and displaying data in a clear and concise manner, thoroughly and accurately documenting all formulation and development work.
- Responsible for raw materials and device selection
- Supports in recruiting, supervising, and mentoring junior-level scientists and technicians in the design and execution of various product development activities.
- Supports in expanding R&D, IVBE and analytical capabilities
- Contribute/develop SOPs and technical documents to support IQ/OQ/PQ of equipment.
- Support in identifying various vendors and coordinate with CMO/CROs; providing technical support for the successful scale-up/Tech. Transfer to filling of NDA/ANDA.
- Interfacing with collaborators and key partners including device companies, R&D leaders, CMC-Leaders, Regulatory Affairs, QC/QA etc.
- Minimum education: MS in Chemistry or Pharmaceutical Sciences or related fields.
- 3-5 years of experience in inhaled product development and testing.
- The candidate must be able to interact effectively with peers and work in a fast-paced environment.
- Excellent communication skills, strong organizational skills, the ability to multitask and effective interpersonal skills are required.