05 Oct
|
MSN Group
|
Hyderabad
05 Oct
MSN Group
Hyderabad
Role & responsibilities
Company: MSN Laboratories
Department: Formulation Technology Transfer
Designation: Executive / Senior Executive
Experience: 2–6 Years
Location: Hyderabad, Telangana
Job Purpose To support and execute formulation technology transfer activities from R&D;/Development to manufacturing sites, ensuring smooth scale-up, process validation readiness, regulatory compliance, and successful commercialization of pharmaceutical products.
Key Responsibilities
- Execute technology transfer activities for oral solid dosage formulations from R&D;/Development to commercial manufacturing.
- Review and understand formulation development reports, batch manufacturing records, process parameters, specifications, and analytical requirements.
- Prepare and review technology transfer documents, including technology transfer protocols, reports, process descriptions, and risk assessments.
- Coordinate with Formulation R&D;, Production, Quality Assurance, Quality Control, Engineering, Regulatory Affairs, and other cross-functional teams.
- Participate in scale-up, exhibit, engineering, validation, and commercial batches.
- Monitor critical process parameters (CPPs) and critical quality attributes (CQAs) during scale-up and technology transfer activities.
- Support troubleshooting of manufacturing/process-related issues and assist in identifying root causes and appropriate CAPA.
- Review manufacturing and development data to identify process gaps and opportunities for improvement.
- Ensure compliance with GMP, SOPs, regulatory requirements, and internal quality systems.
- Support preparation and execution of process validation and continued process verification activities.
- Assist in investigation of deviations, OOS/OOT results, and process-related discrepancies.
- Prepare technical reports, presentations,
and other documentation required for technology transfer and commercialization.
- Coordinate with manufacturing sites for successful implementation of transferred products.
- Support regulatory filing requirements by providing technical and process-related information.
- Maintain proper documentation and ensure timely closure of technology-transfer activities.
Desired Technical Knowledge
- Pharmaceutical formulation development and manufacturing.
- Oral solid dosage forms such as tablets and capsules.
- Scale-up and technology transfer principles.
- Granulation, blending, compression, coating, encapsulation, and related manufacturing processes.
- Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs).
- QbD, Quality Risk Management, and process validation concepts.
- GMP, GDP, and pharmaceutical documentation practices.
- Deviation, change control, CAPA, and investigation processes.
Education Required: M.Pharm / M.S. / B.Pharm in Pharmaceutics, Pharmaceutical Technology, or a related discipline.
Experience
- Executive: 2–4 years of relevant experience in Formulation R&D;, Scale-up, Technology Transfer, or Pharmaceutical Manufacturing.
- Senior Executive: 4–6 years of relevant experience in Formulation Technology Transfer / Scale-up / Manufacturing.
- Experience in regulated pharmaceutical manufacturing and handling technology-transfer projects is preferred.
Key Competencies
- Strong technical understanding of formulation and manufacturing processes.
- Good analytical and problem-solving skills.
- Cross-functional coordination and communication.
- Robust documentation and report-writing skills.
- Knowledge of GMP and regulatory expectations.
- Ability to work effectively with R&D;, Production, QA, QC, and other stakeholders.
- Willingness to travel between development and manufacturing sites when required.
📌 Executive / Sr Executive -Technology Transfer (Hyderabad)
🏢 MSN Group
📍 Hyderabad