Deputy Manager / Manager (Manufacturing Sciences)

The role requires strong hands-on expertise in synthetic organic chemistry, coupled with an understanding of process robustness, scale-up, process safety, GMP requirements, data-driven optimization, and manufacturability. The incumbent will also contribute to the development of flow chemistry, process intensification and continuous manufacturing capabilities within MSAT.

Key Roles & Responsibilities:

A. Process Development & Synthetic Chemistry

Independently design and execute synthetic routes, reaction optimization and process development studies for APIs/intermediates.

Investigate reaction chemistry, kinetics, selectivity, impurity formation and process parameters.

Identify opportunities for improvement in yield, quality, cycle time, solvent/reagent consumption, cost and waste generation.

Conduct LCM and process improvement studies and establish robust and scalable processes.

Evaluate alternative synthetic routes, reagents, catalysts and solvents considering technical, economic, safety and sustainability aspects.

B. Process Optimization & Data Analytics

Design and execute structured experiments using DoE, statistical tools and data-driven approaches.

Identify critical process parameters (CPPs), process risks and their impact on product quality.

Interpret experimental, analytical and manufacturing data to identify trends, variability and root causes.

Translate laboratory findings into practical and scalable manufacturing solutions.

C. Scale-Up & Manufacturing Support

Develop processes with scale-up and manufacturability considerations from the early stages.

Support laboratory-to-kilo/pilot/commercial scale-up and engineering/validation batches.

Provide technical support for manufacturing deviations, process failures, yield losses, impurity excursions and atypical results.

Participate in troubleshooting and implementation of process improvements at manufacturing scale.

Assess equipment capability, mixing, heat/mass transfer and other scale-dependent process challenges.

D. Flow Chemistry & Continuous Manufacturing

Understand principles of batch, flow and continuous manufacturing.

Evaluate reaction suitability for flow processing based on kinetics, heat/mass transfer, mixing, residence time, pressure, solid formation and reaction hazards.

Select and utilize appropriate flow platforms/reactors based on reaction characteristics.

Support development of flow chemistry/process intensification solutions and assess their potential for scale-up and commercial application.

E. Process Safety, EHS & Sustainability

Identify process safety risks during laboratory and scale-up studies, including exothermicity, gas evolution, pressure, thermal instability, hazardous intermediates and decomposition risks.

Work with EHS/Engineering teams on process safety assessments such as FMEA, HAZOP/HAZID, calorimetry and LOPA, as applicable.

Incorporate inherently safer chemistry, solvent reduction, waste minimization and energy-efficient approaches into process development.

F. Technology Transfer & GMP

Support technology transfer of API/intermediate processes from development sites, partners or external organizations.

Review process descriptions, process flow diagrams, equipment trains, process parameters, IPCs and manufacturing records.

Identify technology gaps, scale-up risks and process knowledge requirements.

Contribute to preparation/review of Technology Transfer Protocols/Reports, process development reports, risk assessments and technical documents.

Execute activities in accordance with cGMP, ICH Q7/Q8/Q9/Q10/Q11 and applicable regulatory requirements.

Maintain high standards of documentation, data integrity, laboratory practices and scientific traceability.

Knowledge of USFDA requirements and inspection expectations will be an added advantage.

G. Analytical & Cross-Functional Collaboration

Work closely with Analytical/QC teams for process monitoring, impurity evaluation and analytical data interpretation.

Interpret data from techniques such as HPLC/UPLC, GC, GC-MS/LC-MS, KF, ICP-MS/OES, PSD and thermal/solid-state characterization, as applicable.

Collaborate effectively with Manufacturing, Analytical/QC, QA, Engineering, EHS, Supply Chain, Regulatory and external technology partners.

Act as a technical bridge between process development and commercial manufacturing.

Technical & Behavioural Competencies:

Technical

Strong synthetic organic chemistry and reaction mechanism understanding.

Hands-on experience in API/process development and optimization.

Strong understanding of scale-up and manufacturing processes.

Knowledge of impurity chemistry and process analytical data.

Working knowledge of DoE/statistical analysis and process risk assessment.

Understanding of flow chemistry and continuous manufacturing.

Knowledge of GMP and pharmaceutical regulatory expectations.

Strong scientific documentation and technical report-writing skills.

Experience with data analytics/statistical tools such as JMP, Minitab, SIMCA or equivalent is desirable.

Behavioural

Strong scientific problem-solving and analytical thinking.

Ability to independently plan and execute experiments.

Ownership and accountability for assigned projects.

Effective communication and cross-functional collaboration.

Ability to influence and present technical recommendations.

Safety-first and quality-focused mindset.

Curiosity and willingness to adopt new technologies.

Expected Level of Responsibility:

The incumbent is expected to progressively demonstrate:

Independent ownership of assigned process-development projects.

Ability to identify technical risks and develop mitigation strategies.

Ability to lead process optimization and troubleshooting activities.

Ability to provide scientifically sound recommendations to project teams.

Ability to mentor junior scientists and share technical knowledge.

Contribution to process intensification, flow chemistry, continuous manufacturing and digital/data-driven MSAT initiatives.

Readiness for cGMP Environment:

Practical exposure to QC and 5S initiatives demonstrate well-versed in GMP-compliant practices, documentation, and safety protocols. Knowledge of USFDA requirements will be considered as added advantage.

Future Growth Potential:

Participation in innovative areas such as flow chemistry and continuous manufacturing initiatives involving analytical support for new technologies.