Sr. Team Leader - Formulation Development

Strides Pharma Science; Bengaluru; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Stride Pharma Science in Bengaluru is seeking a specialist in nasal drug-device combination development with expertise across solutions, suspensions, and topical dosage forms. You will contribute to device verification, risk management, and dossier preparation while coordinating with CROs to ensure timely regulatory filings.

The role also covers IVRT/IVPT studies, transdermal patches, and adhesive optimization, requiring hands-on experience and strong scientific knowledge to advance products

Qualifications

• Experience in developing nasal drug-device combinations.
• In-depth knowledge of design verification and risk management for nasal products.
• Hands-on experience with IVRT/IVPT studies and related requirements.
• Experience with transdermal patches and oral films (sublingual/buccal).
• Familiarity with adhesive selection and performance optimization.

Responsibilities

• Plan and execute projects in coordination with CRO to meet committed timelines.
• Coordinate with CRO and cross-functional teams to ensure dossier filing timelines.
• Finalize project execution strategy with CRO, managers, and cross-functional leads to meet regulatory deadlines.
• Coordinate with technology transfer/manufacturing for smooth transfer from CRO to scale-up and commercialization.
• Prepare and review PDP and PDR and other relevant documents with CRO; ensure timely availability of documents for regulatory submissions.

Skills

Nasal device development

Device documentation

Pump performance

IVBE/PBE methods

Topical dosage forms

Rheology

IVRT/IVPT studies

Transdermal patches

Adhesive optimization

Job description

• Expertise in development of Nasal drug device combination products with different dosage forms like solutions, suspensions etc.,
• Have good 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