Executive / Senior Executive – Production Chemist (API)

Scimplify; Gujarat; On-site; INR 600,000 - 900,000; Full time

Job summary

Scimplify is a science-first manufacturing company seeking an Executive / Senior Executive – Production Chemist (API) with ~4 years of API manufacturing experience. The role involves managing production activities, ensuring process efficiency, and adhering to GMP, USFDA, and ICH guidelines.

Travel to various factories will be required to oversee operations. Candidates should have hands-on experience in batch manufacturing, scale-up from R&D to commercial production, and strong documentation and

Qualifications

• 4+ years of hands-on API manufacturing and API synthesis.

Responsibilities

• Execute API and pharmaceutical intermediate manufacturing processes as per Batch Manufacturing Records (BMRs).
• Monitor critical process parameters, including temperature, pressure, pH, and reaction time.
• Handle chemical manufacturing operations such as distillation, crystallization, filtration, and drying.
• Support process scale-up from R&D and pilot scale to commercial production.
• Ensure compliance with GMP, SOPs, USFDA guidelines, and safety standards.
• Maintain accurate BMRs, production logs, and manufacturing documentation.
• Coordinate with QA/QC teams for sampling, testing, and product release.
• Identify and troubleshoot process deviations and support CAPA implementation.
• Improve production yield, minimize material wastage, and enhance process efficiency.
• Ensure proper handling, storage, and transfer of raw materials, intermediates, and finished products.
• Support process validation, equipment qualification, and plant qualification activities.
• Maintain housekeeping, cleanliness, and safety standards at manufacturing facilities.
• Travel to different manufacturing factories to monitor and support production activities as required.

Skills

API manufacturing

Organic chemistry

Scale-up

GMP knowledge

USFDA/ICH

Distillation

Crystallization

Filtration

Drying

CAPA

BMRs

SOPs

Documentation

QA/QC coordination

Troubleshooting

Travel readiness

Job description

4+ Years

Full-Time

About Scimplify

Scimplify is a science-first manufacturing company for Advanced Materials, from specialty chemicals to the building blocks of next-generation energy, life sciences and crop sciences applications. We scale process development and manufacturing as one continuous system, backed by world-class R&D infrastructure and a global network of 500+ manufacturing partners. New materials go from molecule to commercial scale in months, not years. We have teams across 5 countries and 1,000+ innovator customers in 40+ countries, and we are backed by Accel, Bertelsmann, Omnivore, Hitachi Ventures and 3one4 Capital, with over $80M raised.

Job Summary

We are looking for an Executive / Senior Executive – Production Chemist (API) with approximately 4 years of experience in API manufacturing and pharmaceutical intermediates. The candidate will be responsible for managing and monitoring production activities, ensuring process efficiency, maintaining quality standards, and complying with GMP, USFDA, and ICH guidelines.

The role involves travelling to different manufacturing factories to oversee and support production operations.

Key Responsibilities

• Execute API and pharmaceutical intermediate manufacturing processes as per Batch Manufacturing Records (BMRs).
• Monitor critical process parameters, including temperature, pressure, pH, and reaction time.
• Handle chemical manufacturing operations such as distillation, crystallization, filtration, and drying.
• Support process scale-up from R&D and pilot scale to commercial production.
• Ensure compliance with GMP, SOPs, USFDA guidelines, and safety standards.
• Maintain accurate BMRs, production logs, and manufacturing documentation.
• Coordinate with QA/QC teams for sampling, testing, and product release.
• Identify and troubleshoot process deviations and support CAPA implementation.
• Improve production yield, minimize material wastage, and enhance process efficiency.
• Ensure proper handling, storage, and transfer of raw materials, intermediates, and finished products.
• Support process validation, equipment qualification, and plant qualification activities.
• Maintain housekeeping, cleanliness, and safety standards at manufacturing facilities.
• Travel to different manufacturing factories to monitor and support production activities as required.

Required Skills & Experience

• 4+ years of hands-on experience in API manufacturing and API synthesis.
• Strong knowledge of organic chemistry and pharmaceutical intermediates.
• Practical experience in commercial-scale API production and chemical manufacturing operations.
• Hands-on experience in distillation, crystallization, filtration, and drying processes.
• Good understanding of GMP, USFDA, ICH guidelines, BMRs, and SOPs.
• Knowledge of process safety, HAZOP, process validation, and CAPA.
• Ability to monitor critical process parameters and troubleshoot production deviations.
• Experience working with API manufacturing companies, CMO/CDMO facilities, or USFDA-compliant manufacturing plants preferred.
• Strong analytical, problem-solving, documentation, and coordination skills.
• Comfortable travelling frequently to different manufacturing factories as per business requirements.

Why Scimplify?

An opportunity to work with a fast-growing, science-first manufacturing company, gain exposure to diverse API manufacturing facilities, and contribute to scaling pharmaceutical manufacturing operations through process excellence, quality, and innovation.