Executive / Sr Executive -TSD Formulations

Role & responsibilities

TSD Formulation | Executive / Senior Executive Job Description

Job Description – TSD (Formulation)

Company: MSN Laboratories
Department: Technical Services & Development (TSD) – Formulation
Designation: Executive / Senior Executive
Experience: 2–6 Years
Location: Hyderabad, Telangana

Job Purpose

To provide technical support for formulation manufacturing, scale-up, technology transfer, process optimization, troubleshooting, and commercialization of pharmaceutical products while ensuring compliance with GMP, quality, safety, and regulatory requirements.

Key Responsibilities

• Provide technical support to manufacturing operations for formulation products.
• Support technology transfer activities from Formulation R&D / Development to commercial manufacturing sites.
• Review formulation development reports, manufacturing processes, batch records, specifications, and process parameters.
• Coordinate and execute scale-up, exhibit, engineering, process validation, and commercial batches.
• Monitor and evaluate manufacturing process parameters and product quality attributes.
• Identify process-related issues during manufacturing and support effective troubleshooting.
• Conduct root-cause analysis for process deviations, failures, and recurring manufacturing issues.
• Support preparation and review of deviation investigations, CAPA, change controls, and technical assessments.
• Evaluate process trends and manufacturing data to identify opportunities for process optimization and improvement.
• Support process optimization, yield improvement, cycle-time reduction, and reduction of manufacturing variability.
• Review and prepare technical documents such as technology transfer protocols/reports, process evaluation reports, technical investigations, and risk assessments.
• Coordinate with Formulation R&D, Production, QA, QC, Engineering, Regulatory Affairs, and other cross-functional teams.
• Participate in manufacturing trials and provide on-floor technical support during critical batches.
• Support development and implementation of process controls and manufacturing strategies.
• Ensure appropriate identification and evaluation of CPPs, CQAs, and critical material attributes (CMAs).
• Support Process Validation and Continued Process Verification (CPV) activities.
• Review batch manufacturing records and provide technical inputs for process improvements.
• Support investigation of OOS/OOT and other product/process-related quality events from a technical perspective.
• Assist in preparation of responses to regulatory queries related to formulation manufacturing and process development.
• Ensure activities are performed in accordance with cGMP, SOPs, safety requirements, and applicable regulatory guidelines.
• Maintain effective documentation and ensure timely completion of assigned TSD projects.

Technical Skills / Knowledge

• Strong knowledge of pharmaceutical formulation manufacturing processes.
• Experience with Oral Solid Dosage (OSD) products such as tablets and capsules.
• Working knowledge of:
  
• Dispensing and sifting
• Dry/wet granulation
• Blending
• Compression
• Film coating
• Encapsulation
• In-process controls
• Understanding of scale-up and technology transfer principles.
• Knowledge of CPP, CQA, CMA, QbD, and Quality Risk Management.
• Knowledge of process validation and continued process verification.
• Understanding of deviation, change control, CAPA, OOS/OOT, and investigation processes.
• Familiarity with GMP and regulatory requirements.
• Ability to interpret manufacturing and process data for troubleshooting and optimization.

Qualification

• M.Pharm / M.S. (Pharmaceutics/Pharmaceutical Technology) preferred.
• B.Pharm candidates with relevant TSD/Formulation experience may also be considered.

Experience

Executive – 2–4 Years

• Relevant experience in Formulation TSD, Formulation R&D, Technology Transfer, Scale-up, or Pharmaceutical Manufacturing.
• Hands-on exposure to manufacturing troubleshooting and technical documentation.
• Experience supporting formulation manufacturing batches is preferred.

Senior Executive – 4–6 Years

• Relevant experience in Formulation TSD / Technical Services / Technology Transfer / Scale-up.
• Demonstrated experience in troubleshooting formulation manufacturing processes.
• Experience in process optimization, validation batches, technical investigations, and cross-functional project execution.
• Experience in regulated pharmaceutical manufacturing environments preferred.

Key Competencies

• Technical problem-solving and troubleshooting
• Analytical thinking and data interpretation
• Strong knowledge of formulation manufacturing
• Cross-functional coordination
• Technical report writing and documentation
• Good communication and interpersonal skills
• GMP and compliance awareness
• Ability to work independently and manage multiple technical activities
• Strong on-floor manufacturing support capability

Key Performance Areas

• Successful technology transfer and scale-up
• Timely resolution of manufacturing technical issues
• Process optimization and yield improvement
• Successful execution of validation/commercial batches
• Effective deviation and investigation support
• Timely completion of technical documentation
• Compliance with GMP and internal quality systems