22 Aug
|
Strides Pharma Science
|
Bengaluru
22 Aug
Strides Pharma Science
Bengaluru
- Expertise in development of Nasal drug device combination products with different dosage forms like solutions, suspensions etc.,
- Have positive scientific knowledge on Devices requirements and device documentation like design verification, risk management etc. in case of Nasal product.
- Good knowledge on pump performance parameters for device sameness
- IVBE correlation for PBE establishment through statistical methods.
- Expertise in complete development activities of different Topical dosage forms like solutions, cream, lotion, gel, ointment
- Scientific knowledge and Hands on experience in Q3 parameters characterization like PSD, GSD, Rheology, Viscosity etc., and correlation to product development.
- Hands on experience in IVRT studies and good understanding on IVPT studies and requirements.
- Good knowledge on development of transdermal patches and oral films (Sublingual/Buccal)
- Knowledge on adhesives selection and optimization to match adhesive properties and wearability profiles.
- Knowledge on IVPT studies and performance evaluation parameters.
- Responsible for Planning and execution of projects in coordination with CRO as per the committed timelines.
- Co-ordinate with CRO & project management team to ensure adherence to project timelines.
- Project execution strategy finalization in coordination with CRO & manager and various cross functional leads to meet the dossier filing timelines.
- Coordinate with technology transfer / manufacturing department for smooth transfer of new products from CRO to scale-up, exhibit batch and commercialization.
- Responsible for coordinating with CRO for preparation and review of PDP and PDR and other relevant documents.
- Responsible for timely availability of documents to support the dossier compilation and regulatory filing.
- Responsible for addressing regulatory deficiencies in coordination with cross functional teams and CRO
📌 Sr. Team Leader (Bengaluru)
🏢 Strides Pharma Science
📍 Bengaluru