Job Description

Department: Formulation Research and Development (FRD OSD)

Position Title: Manager / Sr. Manager

Experience: 13-20 years
Location: R&D; BASKA, BDR Pharmaceutical International PVT LTD.

Job Type: Full time

Candidate should be having experience in Formulation Research and Development activity of Oral solid dosage form (including but not limited to Tablets, Capsules, Soft Gelatin capsules, Repsules, Oral liquids, Semi solid dosage form and Pellets formulation)

Job Responsibilities:
- Team management and leading the team of 8-10 scientists for Formulation development.
- Overall evaluation of projects not limited to literature search and patent search (including para I, II, III, IV, NCE-1 projects) and developing non-infringing formula and manufacturing processes for the formulation for various Regulated Markets.
- To prepare and execute Formulation Development strategies for adhering to the defined timelines.
- To supervise preformulation studies, development studies for prototype batches.
- To design and supervise various optimization studies,



according to FDA’s QBD guideline during routine development of formulation.
- Identification of QTPPs, CMAs, CQAs, and CPPs and assessment of their risk mitigation strategies by evaluating data of QbD trials.
- To monitor stability studies and correlate data of Lab and Scale up batches.
- To analyses and review various analytical data including preformulation, feasibility, development, scale up and Submission batches. Hands on experience on evaluating BE study data.
- To propose specifications for Raw materials, In-process and finished products.
- To manage departmental activities not limited to indent and organize sufficient raw materials and packaging materials required for execution of development and submission batches, Capex building for new technologies introduction to R&D.;
- To plan exhibit batches, and to evaluate required documents like BMR, BPR, additional study protocols, Product development report

📌 Sr Manager Formulation (Halol)
🏢 BDR Pharmaceuticals
📍 Halol