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