Executive-API R&D Synthesis with Growing Russia based Pharma

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We would like to inform you that presently we have professional career opportunity matching to your profile with one of our esteemed client.

Please see the following position summary:

• Client Name: Growing Russia based Pharma
• Position: Executive-API R&D Synthesis
• Department: API R&D
• Location: Navi Mumbai

Role Objective:

Invent non-infringing, cost-effective, and safe synthetic pathways to create active pharmaceutical ingredients from lab scale to commercial production.

Job Profile:

Process Synthesis & Development:

• Conduct laboratory-scale chemical reactions for API and intermediate development.
• Develop, evaluate and optimize synthetic routes for new and existing molecules.
• Perform reaction monitoring, work-up, purification and isolation of products.
• Study reaction parameters such as temperature, time, solvent, catalyst and reagent quantities.
• Identify suitable and commercially feasible synthetic processes.

Process Optimization & Troubleshooting:

• Optimize chemical processes to improve yield, purity, reproducibility and process efficiency.
• Identify and troubleshoot issues related to reaction, impurity formation, crystallization and purification.
• Conduct experiments to understand and minimize process-related impurities.
• Support development of robust and scalable processes for commercial manufacturing.

Scale-Up & Technology Transfer:

• Help transition chemical processes from small laboratory setups to pilot plants or large-scale production.
• Support scale-up of laboratory processes to pilot and manufacturing scale.
• Assist in preparing process descriptions, batch procedures and scale-up documents.
• Participate in technology transfer activities from R&D to production.
• Provide technical support during pilot and commercial batches and resolve process-related issues.

Analytical Testing & Data Interpretation

• Possess basic working knowledge of analytical techniques such as HPLC, GC, MS and NMR.
• Review and interpret analytical results to assess product purity, impurities and reaction completion.
• Coordinate with analytical teams for testing and characterization of API/intermediate samples.
• Maintain proper records of analytical observations and experimental results.

Documentation & Compliance:

• Documentation & Regulatory Compliance
• Maintain accurate and timely documentation of daily experiments, observations and results.
• Prepare experimental reports, process development reports and supporting technical documents.
• Follow applicable GMP, safety and laboratory procedures during development activities.
• Support preparation and compilation of technical information required for regulatory submissions, including DMF-related documentation.
• Ensure proper traceability and data integrity of experimental and development records.

Safety & Good Laboratory Practices:

• Follow laboratory safety procedures while handling chemicals, reactions and laboratory equipment.
• Ensure proper handling, storage and disposal of chemicals and laboratory waste.
• Maintain a clean, organized and compliant laboratory environment.
• Follow GLP/GMP principles and company quality systems applicable to R&D activities.

Desired Profile:

• M.Sc (Chemistry / Organic Chemistry / Pharmaceutical Chemistry) with 4 to 7 years experience in R&D experience in bulk drug or API manufacturing environments.
• Relevant experience in API / Intermediate Process Development, R&D or Process Chemistry within the pharmaceutical industry.
• Strong practical knowledge of organic synthesis, reaction chemistry, purification and process development.
• Hands-on experience in laboratory-scale reactions, reaction optimization and impurity control.
• Good understanding of process scale-up, technology transfer and manufacturing process troubleshooting.
• Basic knowledge of analytical techniques including HPLC, GC, MS and NMR, with the ability to understand and interpret analytical results.
• Ability to analyse experimental data and make appropriate technical decisions based on observations and results.
• Good understanding of GMP, GLP, laboratory safety and chemical handling practices.
• Experience in preparing experimental records, process development reports, technical reports and regulatory documentation/DMF-related data.
• Deep knowledge of organic synthesis, lab safety (EHS guidelines), analytical data interpretation, and process optimization.
• Should have basic understanding and result interpterion knowledge about instruments like HPLC, GC, MS, and NMR to check product purity.
• Knowledge about technical development reports, safety protocols, and regulatory documents like Drug Master Files (DMF) while following Good Manufacturing Practices (GMP).
• Good documentation, report-writing and communication skills.
• Strong problem-solving, analytical and experimental skills with a result-oriented approach.
• Ability to work independently as well as effectively coordinate with Analytical, Production, Quality and Regulatory teams.

Recruiter's Contact Details:

BEST-FIT Recruitment Riders

G-7, Amrit Complex,

Opp: Mahavir Jain Vidhyalaya & Jain Derasar,

R.V. Desai Road, Near Goyagate Circle,

Vadodara-390001, Gujarat, India

Mobile: 07226009222, 09722042906

E-Mail: [email protected]

Website: www.bestfitrecruitment.co.in