Manager - FRD (Complex Injectable - Russia & CIS Countries)

Best Fit Recruitment Rider; Navi Mumbai; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Growing Russia based Pharma is seeking a senior Manager - FRD to lead development of complex injectable formulations for Russia and CIS markets from lab-scale to commercial production. Based in Navi Mumbai, the role includes regulatory support, technology transfer and cross-functional coordination with QA, Manufacturing and Regulatory teams.

The candidate should have 8–12 years in Formulation R&D (M.Pharm/Ph.D.) with strong sterile injectable experience and a proven track record in scale-up and

Qualifications

• M.Pharm / Ph.D with 8 to 12 years experience in Formulation Research & Development in Pharmaceutical R&D.
• Strong experience in Sterile injectable development.
• Proven experience in formulation development, process optimization, scale-up and technology transfer.
• Deep knowledge of sterile practices, excipient compatibility, lyophilization cycles, and QbD (Quality by Design) principles
• Strong hands-on experience in complex injectable formulation development, including solutions, suspensions, emulsions and lyophilized injectable.
• Exposure to liposomal, nanoparticle, microsphere and long-acting/depot formulations will be preferred.
• Expertise in product development for Russian / CIS markets would be preferred first.
• Proven track record of successful product launches and regulatory approvals.

Responsibilities

• Lead formulation development of complex injectable formulations including solutions, suspensions, emulsions and lyophilized products.
• Develop and optimize advanced drug-delivery systems such as liposomes, nanoparticles, microspheres and long-acting/depot injectable.
• Select suitable APIs, excipients and formulation components based on product requirements.
• Conduct formulation trials, optimization studies and evaluate product performance.
• Develop and optimize robust manufacturing processes for sterile injectable products.
• Identify and optimize CQAs and CPPs.
• Troubleshoot formulation and process-related issues and implement corrective actions.
• Support aseptic processing, sterile filtration, filling and lyophilization activities.
• Lead scale-up activities from laboratory to pilot and commercial manufacturing scale.
• Prepare/review scale-up protocols, process documents and technology-transfer reports.
• Coordinate with Analytical Development, QC, QA, Manufacturing, Engineering and Regulatory Affairs teams.
• Provide technical support for analytical studies, investigations, deviations, CAPA and change controls.
• Support manufacturing and quality teams in resolving product and process-related issues.
• Lead and mentor formulation development scientists and technical team members.
• Plan and execute multiple formulation development projects within defined timelines.
• Review technical reports, protocols, experimental data and development documentation.
• Drive continuous improvement and scientific problem-solving within the formulation development team.

Skills

Formulation Development

Sterile Injectables

Technology Transfer

QA/Regulatory

Scale-Up

DoE/QbD

Analytical Understanding

Education

M.Pharm / Ph.D

Job description

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: Growing Russia based Pharma
• Position: Manager - FRD
• Markets: Russia & CIS countries + ROW
• Products: Complex Injectable, Lyophilized, Emulsion, Suspension
• Reporting to: Director
• Job Location: Mahape, Navi Mumbai

Role Overview:

• Responsible for the development, optimization, and scale-up of pharmaceutical complex injectable like solutions, suspensions, emulsions, lyophilized powders, liposomes, nanoparticles, and long-acting depot/microsphere systems for Russia and CIS regulatory markets. The role includes product development, regulatory support, technology transfer, and commercialization support aligned with the regulatory requirements of Russia, Kazakhstan, Belarus, Uzbekistan, and other CIS countries. Core objective is to invent cost effective & safe formulation method to create parental drug from lab scale to commercial production.

Role & responsibilities:

Formulation Development:

• Lead development of complex injectable formulations including solutions, suspensions, emulsions and lyophilized products.
• Develop and optimize advanced drug-delivery systems such as liposomes, nanoparticles, microspheres and long-acting/depot injectable.
• Select suitable APIs, excipients and formulation components based on product requirements.
• Conduct formulation trials, optimization studies and evaluate product performance.

Process Development & Optimization:

• Develop and optimize robust manufacturing processes for sterile injectable products.
• Identify and optimize Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs).
• Troubleshoot formulation and process-related issues and implement appropriate corrective actions.
• Support aseptic processing, sterile filtration, filling and lyophilization activities.

Scale-Up & Technology Transfer

• Lead scale-up activities from laboratory to pilot and commercial manufacturing scale.
• Support engineering, exhibit and validation batches.
• Prepare/review scale-up protocols, process documents and technology-transfer reports.
• Work with manufacturing teams to resolve scale-up and commercial production challenges.

Stability & Product Evaluation:

• Plan and monitor stability studies as per ICH guidelines and regulatory requirements.
• Evaluate physical, chemical and performance characteristics of injectable formulations.
• Review stability data and support determination of appropriate storage conditions and shelf life.

Cross-Functional Coordination:

• Coordinate with Analytical Development, QC, QA, Manufacturing, Engineering and Regulatory Affairs teams.
• Provide technical support for analytical studies, investigations, deviations, CAPA and change controls.
• Support manufacturing and quality teams in resolving product and process-related issues.

Team & Project Management:

• Lead and mentor formulation development scientists and technical team members.
• Plan and execute multiple formulation development projects within defined timelines.
• Review technical reports, protocols, experimental data and development documentation.
• Drive continuous improvement and scientific problem-solving within the formulation development team.

Preferred candidate profile

• M.Pharm / Ph.D with 8 to 12 years experience in Formulation Research & Development in Pharmaceutical R&D.
• Strong experience in Sterile injectable development.
• Proven experience in formulation development, process optimization, scale-up and technology transfer.
• Deep knowledge of sterile practices, excipient compatibility, lyophilization cycles, and QbD (Quality by Design) principles
• Strong hands-on experience in complex injectable formulation development, including solutions, suspensions, emulsions and lyophilized injectable.
• Exposure to liposomal, nanoparticle, microsphere and long-acting/depot formulations will be preferred.
• Expertise in product development for Russian / CIS markets would be preferred first.
• Proven track record of successful product launches and regulatory approvals.
• Knowledge of Design of Experiments (DoE) and Quality by Design (QbD) approaches.
• Strong understanding of aseptic processing, sterile filtration, filling and lyophilization.
• Experience in laboratory-to-pilot and commercial-scale scale-up and technology transfer.
• Ability to plan and manage multiple product development projects simultaneously.
• Good understanding of ICH, cGMP, USFDA/EMA and regulatory requirements.
• Expertise in solving formulation challenges related to bioavailability, stability, and manufacturability.
• Ability to interpret analytical data, stability data, and dissolution profiles.
• Experience in technology transfer from R&D to commercial manufacturing.
• Strong documentation and regulatory knowledge.
• Exposure to international audits and regulatory inspections.
• Ability to work in a fast-paced international pharmaceutical environment.
• Experience in cross-functional coordination and team leadership.