Opening For Jr Manager -FR&D (Injectables)

Role & responsibilities

Position

Junior Manager Formulation Development (Parenterals)

Department

Formulation Development / R&D

Qualification

M.Pharm

Experience

6–8 years of relevant experience in pharmaceutical formulation development, preferably in Parenteral / Injectable formulations.

Job Location MSN R&D Center

Job Purpose

To lead and execute formulation development activities for parenteral products from pre-formulation through formulation optimization, scale-up, technology transfer, and regulatory submission, ensuring compliance with applicable GMP and regulatory requirements.

Key Responsibilities

• Lead formulation development activities for sterile parenteral products, including liquid injections, lyophilized injections, and other relevant injectable dosage forms.
• Design and execute formulation development strategies based on product requirements, QTPP, CQAs, and risk assessment.
• Conduct pre-formulation studies and evaluate API characteristics, excipient compatibility, solubility, stability, and other critical formulation parameters.
• Develop and optimize formulations with respect to assay, impurities/degradation, pH, osmolality, viscosity, particulate matter, sterility, and other critical quality attributes.
• Evaluate and select suitable excipients, container-closure systems, and processing parameters for injectable products.
• Plan and execute laboratory, pilot, and scale-up batches.
• Coordinate with Analytical R&D, IPQA, Manufacturing, Engineering, Packaging, Regulatory Affairs, and Quality Control teams for product development activities.
• Support development and optimization of sterilization processes, including terminal sterilization and aseptic processing, as applicable.
• Coordinate activities related to lyophilization cycle development and optimization for freeze-dried injectable products.
• Generate, review, and approve formulation development protocols, reports, batch manufacturing records, specifications, and other technical documents.
• Interpret analytical and stability data and provide scientific rationale for formulation/process decisions.
• Participate in QbD, DoE, risk assessment, and process optimization activities.
• Support technology transfer from R&D to manufacturing and provide technical assistance during exhibit, engineering, registration, and validation batches.
• Investigate formulation and process-related deviations, OOS/OOT trends, and stability failures, and recommend appropriate CAPA.
• Review stability data and contribute to product shelf-life assessment and formulation improvement.
• Prepare technical sections/documents required for CTD/eCTD regulatory submissions, as applicable.
• Support responses to regulatory queries and provide technical justification/data when required.
• Ensure development activities are executed in accordance with cGMP, GLP, SOPs, data integrity principles, and applicable regulatory guidelines.
• Mentor junior scientists/executives and provide technical guidance on formulation development activities.
• Maintain project timelines and coordinate multiple development projects to ensure timely completion.

Technical Skills / Competencies

• Strong understanding of parenteral formulation development and sterile product manufacturing processes.
• Knowledge of aseptic processing, sterilization, filtration, filling, and lyophilization.
• Good understanding of pre-formulation, formulation optimization, DoE/QbD, risk assessment, and scale-up principles.
• Knowledge of injectable product characterization and critical quality attributes.
• Familiarity with ICH guidelines, USFDA/EMA requirements, WHO guidelines, and relevant pharmacopoeial requirements.
• Understanding of container-closure integrity and compatibility considerations for parenteral products.
• Strong technical documentation and scientific report-writing skills.
• Ability to analyze experimental data and troubleshoot formulation/process problems.
• Good project management, interpersonal, and cross-functional coordination skills.
• Working knowledge of MS Office and relevant R&D documentation systems.

Preferred Experience

Candidates with experience in one or more of the following will be preferred:

• Liquid and lyophilized injectable formulation development
• Complex parenteral formulations
• Sterile manufacturing/aseptic processing
• Injectable product scale-up and technology transfer
• Formulation optimization using DoE/QbD
• Regulatory filing support for regulated markets
• Stability and formulation troubleshooting
• Development of products for US/EU/regulated markets

Key Performance Indicators (KPIs)

• Timely completion of formulation development projects
• Successful formulation optimization and scale-up
• Right-first-time development batches
• Successful technology transfer to manufacturing
• Regulatory submission support and query resolution
• Compliance with R&D quality and documentation requirements
• Effective troubleshooting and resolution of formulation-related issues
• Innovation and improvement in formulation/process development