Deputy Manager Manager (Manufacturing Sciences)

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Shape the future of manufacturing at Zydus Takeda.
Join our MSAT team as a Deputy Manager/Manager and turn scientific innovation into robust scalable processes that help deliver life-changing medicines to patients worldwide.

Here is exciting job opportunity for you !

Zydus Takeda Healthcare Pvt. Ltd. is a strategic joint venture betweenZydus Healthcare Ltd. a leading Indian pharmaceutical company with a global presence andTakeda Pharmaceuticals Japans largest pharmaceutical company with operations worldwide. Combining strong local expertise with global innovation the company is committed to delivering high-quality healthcare solutions and improving patient lives. We are located at Navi Mumbai location.

Position - Deputy Manager / Manager - Manufacturing Sciences & Analytical Technology (MSAT)

Education & Experience . / Ph.D. in Organic Chemistry Medicinal Chemistry Pharmaceutical Chemistry or equivalent

Job description:

1. Role Purpose:

The incumbent will be responsible for synthetic process development reaction optimization scale-up process characterization Life Cycle Management (LCM) technology transfer and manufacturing support for APIs and intermediates.

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.

2. 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.

3. 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.

4. 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.