Assistant Manager - Formulations Research and Development - OSD

Cdymax India Pharma; Bengaluru Urban; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Cdymax India Pharma seeks a formulation development professional to lead robust product development, optimize processes, and ensure timely delivery of high-quality finished dosage forms. Responsibilities include lab-scale development, scale-up, tech transfer, stability and bioequivalence work, plus cross‑functional coordination with QA, regulatory and manufacturing.

The role requires literature and patent reviews, QbD implementation per FDA/ICH guidelines, and preparation of product review

Responsibilities

• Develop robust formulation and process to deliver high quality products on time.
• Characterization, lab scale development, scale-up, technology transfer and scale-up operations for finished drug products.
• Conduct R&D development trials, achieve critical quality attributes and manufacturing stability and bioequivalent batches.
• Prepare and review IP-related reports for new molecules and regulatory filings.
• Perform literature searches, patent reviews, pre-formulation studies and literature reviews.
• Apply QbD principles in formulation development per FDA/ICH guidelines.
• Analyze and report data clearly; provide conclusions and recommendations.
• Review and close final prototype formulation with behavior close to innovator drug.
• Prepare product review presentations and coordinate procurement from vendors.
• Plan new product development for global markets and train staff on SOPs and safety.
• Coordinate with customers and CROs for bioequivalence sample shipments and regulatory submissions.
• Monitor in-house bioequivalence results and obtain CRO documents for regulatory submission.

Job description

Role & responsibilities

• Responsible for development of robust formulation and process to deliver high quality products within the specified timelines by utilizing available resources in best manner.


• Responsible for characterization, lab scale development, scale-up, technology transfer and scale-up operations to manufacture the finished drug products.


• Conducting day-to-day execution of R&D development trials, achieving desired critical quality attributes and manufacturing the stability batches and bioequivalent batches.


• Preparing and reviewing the summary report of IP review of the new molecule to bypass the innovator patents for NCE-1, Para-IV and 505b2 filing.


• Responsible for Literature search, patent search, Pre-formulation studies and preparing the literature review presentation of selected new molecules.


• Applying QbD principles as an integral part of formulation development as per FDA/ICH guidelines.


• Analyzing and reporting the data accurately in a clear and concise manner: suggesting conclusions and recommendations.


• Reviewing and closing of final prototype formulation, which is closet in behavior to the innovator drug.


• Preparing product review presentations of the formulation development.


• Procurement of raw materials, packaging materials and innovator product from different vendors for selected finalized projects.


• New product development planning for global markets (China/EU/US/WHO/Brazil ).


• Giving SOP training and external training to all departmental employees and adhering to the health and safety polices, keeping the lab and laboratory equipment clean.


• Responsible for review of Lab note books, product development report and protocols (Stability/Hold time study etc.) and manufacturing records (Maser formula card, Master packing card etc.)


• Coordinating with cross functional teams for smooth execution of projects to meet project timelines


• Drafting QTPP for the selected products and formulation strategies to achieve target attributes


• Co-ordinating with customer and CRO for bioequivalence sample shipment document preparation, arranging the Bioequivalence samples, shipment and getting the return information from CRO or customer for delivery of Bioequivalence sample.


• For In-House products, arranging of the study synopsis, review of synopsis, requesting and review of study protocols, Bioequivalence sample shipment document preparation, arranging the Bioequivalence samples, shipment and getting the return information from CRO for delivery of Bioequivalence samples.


• Monitoring and reviewing of the In-House product Bioequivalence results and arranging the required document from CRO for regulatory submission.

Preferred candidate profile

The preferred candidate should be a male professional with OSD experience and a strong oncology background, as this would be a good fit for our requirements.