Scientist / Sr. Scientist-API
Client Profile: Pharmaceutical Manufacturer
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Position: Scientist / Sr. Scientist-API
Location: Navi Mumbai
Reporting Manager: HOD- API
Reporting: 3
Criteria: Master or PhD in Chemical Engineering with 5+ Years of experience in pharma process engineering with knowledge of Crystallization, Process Scale up and manufacturing.
Accountabilities:
- Knowledge / Skill / Competencies
- Managing various projects to support new & current Business requirements
- Identify and Managing scope for process improvement
- Ensure EHS and cGMP practices
Major Activities / Tasks:
- Comprehensive knowledge on Crystallization, API Polymorphism (Salt screening & form selection), Particle Size Reduction and capability to achieve the required PSD for various applications of dosage forms.
- Understanding of drug formulation requirements & processes
- Awareness of Powder Flow properties & improvement techniques
- Demonstrates strong scientific knowledge and thinking to navigate project and the business forward
- Effectively and efficiently explains and presents complex scientific concepts to diverse audiences
- Develops creative solutions to complex problems demonstrating scientific and business knowledge, but likewise
- Conduct experiments in lab for developing robust, scalable and economically viable crystallization processes for APIs and their associated intermediates
- Coordinate chemistry, formulation and analytical resources as needed, including pilot plant / manufacturing, quality control, quality assurance, supply, regulatory affairs
- To develop and implement the new techniques to get desired product quality in Manufacturing like process analytical tools (React-IR, Raman, Focused beam reflectance measurement, etc.)
- Work closely with chemistry and formulation team to resolve issues in API or drug product development & scale-up
- Idea generation and action plan to improve current process challenges
- To identify the scope for further development in existing crystallization processes
- Use of engineering calculations and use of advance software like Computational Fluid Dynamics, Dynochem, Minitab (Design of Experiments), etc. for process insights and improvement
- Discussion & Review by internal and external subject matter experts to improve process understanding
- Knowledge of cGMP standards and current regulatory requirement for APIs.
- Should have knowledge of Safety Procedure, FMEA, PHA, HAZOP etc.
- Awareness of Powder Safety.
- Involvement on handling of highly active & potent APIs and containment.
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Interested candidates are requested to please share their resumes, please mention your total experience in this field, your current ctc [fixed, variable, take home], your expectation, and your notice period.
Pl note: Our client have stringent reference check policy, so pls do not provide any mis-leading information nor do suppress any information.
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To apply for this job, send your resume on pmcplconsultant@gmail.com