API MSAT Lead

Biocon; Hyderabad; On-site; INR 4,000,000 - 7,000,000; Full time

Job summary

Biocon in Hyderabad seeks an MSAT Lead for small molecules to bridge development and commercial production, ensuring safe, efficient GMP-compliant processes.

You will manage tech transfers, process validation, and continuous optimization of APIs and drug products, lead cross-functional tech teams, and support health authority audits. This role requires 15+ years of pharma experience and strong GMP expertise.

Qualifications

• 15+ years in pharmaceutical development or technical operations with GMP background.
• Advanced degree in Chemical Engineering, Chemistry or Pharmacy.
• Experience with technology transfer, process validation, and regulatory filings.

Responsibilities

• Lead complex troubleshooting of manufacturing deviations and implement CAPA.
• Manage tech transfer and scale-up from R&D to commercial manufacturing.
• Provide technical governance for external CDMOs.
• Author and approve process validation protocols and reports.
• Support regulatory filings and health authority audits as SME.
• Coordinate with QA related to validation, qualification, and audits.
• Review process documents (PFD, P& IDs, HAZOP, risk assessments) and change controls.
• Plan experiments for user trials and guide data generation for validation batches.
• Oversee CAPA initiation and closure and investigations (OOS/OOT).
• Review SOPs, EOPs, and IOP Annexures.
• Prepare annual/quarterly planners and capex reviews.
• Ensure effective implementation of quality and EHS management.

Skills

Troubleshooting

Technology Transfer

CDMO Oversight

Validation Lifecycle

Regulatory Support

Synthesis

Crystallization

Powder Blending

Granulation

Data Analysis

Education

M.S. or higher in Chemical Engineering / Chemistry / Pharmacy

Job description

An MSAT (Manufacturing Science and Technology) Lead for small molecules bridges pharmaceutical development and commercial production, ensuring chemical manufacturing processes are safe, efficient, and compliant.

The MSAT Lead manages the technical lifecycle, technology transfers, process validation, and continuous optimization of Active Pharmaceutical Ingredients (APIs) and small-molecule oral or sterile drug products.

Key Responsibilities

• Process Troubleshooting: Lead complex investigations into manufacturing deviations, identify root causes, and implement corrective actions.
• Technology Transfer: Manage the scale-up and transfer of chemical synthesis or formulation processes from R&D to commercial manufacturing sites.
• CDMO Oversight: Provide technical governance and oversight for external Contract Development and Manufacturing Organizations.
• Validation & Lifecycle: Author and approve process validation protocols, reports, and continuous process verification plans.
• Regulatory Support: Draft and review technical sections for regulatory filings and act as the subject matter expert during health authority audits.
• Education: Advanced degree (master’s preferred) in Chemical Engineering, Chemistry, or Pharmacy.
• Experience: 15+ years in pharmaceutical development or technical operations, with a strong background in Good Manufacturing Practices (GMP).
• Technical Knowledge: Expertise in small-molecule synthesis, crystallization, powder blending, granulation, and analytical data analysis.

Detailed JD:

• 1 Compliance to laboratory procedures.
• 2 Technology transfer activities for new projects form RND and execution of development and validation batches. Participate in the meeting during the technology transfer and provide solutions to resolve the scalability parameters during the execution.
• 3 Debottleneck projects for capacity enhancement, process improvements through operational efficiency
• 4 Listing the Capex requirements along with review with the teams for the commercial molecules
• 5 Review of all projects related documentation like MFR, MFR amendment, BMRs, Risk assessments.
• 6 Review the process facility and document related change controls.
• 7 Review the Study protocols & Reports (Thermal mapping protocols & Reports) and Performance Qualification Protocols & Reports.
• 8 Plan and review the experiments for the user trials and guide the team to generate relevant data that is forming basis for the validation batch.
• 9 Review to CAPA initiation & Closure (With Respect to Audits, Errata & Deviations). 8 Review to Deviations reporting & investigations (Supporting documents preparation).
• 10 Review the OOS, OOT and investigations documents.
• 11 Review the SOP’s, EOP’s and IOP" s related Annexures.
• 12 Review the Annual / Quarterly Planners.
• 13 Repartee’s attendance and leaves approval.
• 14 Ensuring effective implementation of quality and EHS management system in the department.
• 15 Preparation of capex and revenue of Budget for department function.
• 16 Participate in quality and EHS audits.
• 17 To follow established procedures and policies of the company pertaining to quality and EHS management.
• 18 Review the PFD, P &ID, Equipment suitability, HAZOP, risk assessment, mass balances etc.
• 19 Continual improvement process in the existing and new products.
• 20 Application of modern technologies into process wherever possible to ease the workflow & work.
• 21 To coordinate with QA for all validation, qualification, and audit preparedness