Executive / Sr Executive -TSD Formulations

MSN Group

Hyderabad

On-site

INR 600,000 - 1,200,000

Full time

5 days ago
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Job summary

MSN Laboratories in Hyderabad, Telangana, is seeking an Executive / Senior Executive for TSD Formulation to provide technical support, drive scale-up and technology transfer, and ensure GMP-compliant operations on the shop floor.

You will collaborate with Formulation R&D, Production, QA/QC, Engineering, and Regulatory affairs to optimize processes, investigate deviations, and prepare technical documentation for regulatory queries.

Qualifications

  • Minimum 2–6 years of relevant experience in Formulation TSD/Technology Transfer.
  • Hands-on exposure to manufacturing troubleshooting and technical documentation.
  • Experience supporting formulation manufacturing batches preferred.

Responsibilities

  • Provide technical support to manufacturing operations for formulation products.
  • Support technology transfer activities from Formulation R&D to commercial sites.
  • Review development reports, processes, batch records, specs, and parameters.
  • Coordinate scale-up, engineering, and commercial batches.
  • Monitor process parameters and product quality attributes.
  • Identify and troubleshoot process-related issues during manufacturing.
  • Conduct root-cause analysis for deviations and failures.
  • Prepare deviation investigations, CAPA, change controls, and technical assessments.
  • Review batch records and provide inputs for process improvements.
  • Ensure compliance with cGMP and regulatory guidelines.

Skills

Formulation
Scale-up
Tech transfer
Troubleshooting
GMP

Education

M.Pharm / MS preferred
B.Pharm considered

Tools

Process validation

Job description

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
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