Deputy Manager / Manager (Manufacturing Sciences)

Takeda

Navi Mumbai

On-site

INR 1,800,000 - 3,000,000

Full time

7 days ago
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Job summary

Zydus Takeda Healthcare Pvt. Ltd. in Navi Mumbai is hiring Deputy Manager/Manager for Manufacturing Sciences & Analytical Technology (MSAT).

You will drive synthetic process development, scale-up, and data-driven optimization for APIs and intermediates, with emphasis on flow chemistry and continuous manufacturing. The role requires hands-on experience in organic synthesis, GMP, and technology transfer, along with DoE/statistical tools and strong collaboration across QC, Regulatory and

Qualifications

  • Education & Experience – M.Sc./Ph.D. in Organic Chemistry, Medicinal Chemistry, Pharmaceutical Chemistry or equivalent

Responsibilities

  • Design and execute synthetic routes and process development studies for APIs/intermediates.
  • Evaluate reaction chemistry, kinetics, impurity formation and process parameters.
  • Identify improvements in yield, quality, cycle time and solvent consumption.
  • Lead technology transfer and GMP-compliant documentation.
  • Collaborate with Analytical/QC and Manufacturing for scale-up and optimization.

Skills

Synthetic organic chemistry
Process development
Data-driven optimization
DoE/statistical analysis
Flow chemistry
GMP compliance

Education

M.Sc./Ph.D. in Organic Chemistry or related

Tools

HPLC/UPLC
GC
GC-MS/LC-MS
KF
ICP-MS/OES

Job description

Job Description

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, Japan’s 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 – M.Sc. / 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 use 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.

Locations

IND - Navi Mumbai

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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