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Job Description
- 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.
- 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.
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.
Skills
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