Assistant Manager

Purpose

To ensure the smooth and compliant transfer of pharmaceutical formulations from R&D to manufacturing, ensuring scalability, consistency, and regulatory compliance for successful product commercialization.

Position / Job Title

Assistant Manager

Department

Technology Transfer

Reporting To

Senior Manager

Location

Ambernath

Years Of Experience

10-12 Years

Dosage Form

Solid Orals and / or Nasal

Job Responsibilities / Deliverables

Strategy for Exhibit batches

Determination of batch size considering equipment capacity and demand volume.

Preparation of material budget for scale up and exhibit batches

Evaluation of change parts/tooling and its procurement.

Process optimization

Define process parameters during trial / scale up, exhibit, process validation batches.

Application of scale up factors and other data to derive process parameters

Documentation

Prepare/review batch records like BMR & BPR,

Prepare/review protocols like process validation protocol, hold time protocol, Product transfer protocol

Prepare/review reports like process validation report, hold time report, scale up report, product transfer report.

Execution

Manufacturing process optimization / scale up, exhibit, process validation batches at plant

Process monitoring of Demo batches at R&D to evaluate process feasibility at plant

QMS

Preparation/review of change control for new product, document revision, changes in process etc.

Investigation of deviation and OOS
-phase II

Trouble shooting:

To troubleshoot issues related to manufacturing process in commercial products and exhibit batches.

Qualifications & Pre-Requisites

M Pharm (Pharmaceutics)

Excellent understanding of unit operations involved in manufacturing of solid oral dosage forms i.e. Granulation, Blending, Compression, Coating, Capsulation etc. and nasal operations.

Experienced in handling manufacturing process related troubleshooting.

Experienced in documents (Batch records, PEP/PVP, HTSP, PER/PVR, HTSR etc.)

Knowledge of QMS handling (change control, deviation / OOS investigation) & regulatory requirements (SUPAC).

Good communication skills.

Additional Notes

Role is expected to work in all shifts.