Assistant Formulation Development Manager

Genvicure Therapeutics; Mumbai; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

Genvicure Therapeutics is seeking an experienced Assistant Manager / Deputy Manager – Formulation Development (F&D) to lead development of complex formulations including tablets, capsules, pellets, and injectable dosage forms. You will oversee formulation design, process optimization, scale-up, stability and cross-functional coordination throughout the lifecycle.

The role requires M. Pharm with 8–10 years’ experience in F&D and hands-on expertise in Solid Oral Dosage Forms; injectable

Qualifications

• M. Pharm qualification from a recognized institution.
• 8–10 years of relevant experience in pharmaceutical Formulation Research & Development.
• Hands-on experience in Solid Oral Dosage Forms (tablets, capsules, pellets).
• Experience in injectable product development is preferred.
• Strong understanding of QbD, QTPP, CQA, CPP, CMA, DoE and risk assessment.
• Experience in formulation optimization, scale-up, exhibit batches and technology transfer.
• Knowledge of pharmaceutical development documentation and regulatory requirements.
• Strong analytical and scientific problem-solving capabilities.
• Ability to lead technical investigations and mentor junior formulation development team members.

Responsibilities

• Conduct literature and patent searches to support formulation development strategy.
• Design prototype formulations for tablets, capsules, pellets and injectable dosage forms.
• Design and optimize formulations based on API characteristics, QTPP, CQAs and product development requirements.
• Conduct pre-formulation studies including solubility, particle size, polymorphism, flow properties, drug-excipient compatibility and stability assessment.
• Identify and optimize CPPs and CMAs.
• Perform formulation and process optimization using QbD, risk assessment, DoE and other scientific approaches.
• Plan and execute laboratory, pilot, engineering, exhibit and scale-up batches.
• Evaluate analytical data and identify formulation or process variables affecting product performance.
• Support technology transfer and scale-up activities from laboratory to pilot and commercial scale.
• Provide technical support during exhibit, validation and commercial batches.
• Prepare and review Formulation Development Reports, protocols, risk assessments, MFR/BMR, specifications, process descriptions and other development documentation.

Skills

Formulation Development

Solid Oral Dosage Forms

Tablet & Capsule Formulation

Process Optimization

QbD & DoE

Tech Transfer

Regulatory Documentation

Cross-functional Coordination

Mentoring Juniors

Education

M. Pharm

Job description

Assistant Manager / Deputy Manager Formulation Development (F&D)

Location: Turbhe, Navi Mumbai, Maharashtra

Department: Formulation Research & Development (F&D)

Qualification: M. Pharm

Experience: 8–10 Years

Employment Type: Full-time | On-site

Role Summary

We are looking for an experienced Assistant Manager / Deputy Manager – Formulation Development (F&D) to lead and support the development of complex pharmaceutical formulations, including Solid Oral Dosage Forms (Tablets, Capsules and Pellets) and Injectable Dosage Forms.

The role will be responsible for formulation design, process optimization, scale-up, stability evaluation, technical documentation and cross-functional coordination throughout the product development lifecycle.

Key Responsibilities

• Conduct comprehensive literature and patent searches to support formulation development strategy.
• Design and develop prototype formulations for tablets, capsules, pellets and injectable dosage forms.
• Design and optimize formulations based on API characteristics, QTPP, CQAs and product development requirements.
• Conduct pre-formulation studies including solubility, particle size, polymorphism, flow properties, drug-excipient compatibility and stability assessment.
• Identify and optimize Critical Process Parameters (CPPs) and Critical Material Attributes (CMAs).
• Perform formulation and process optimization using Quality by Design (QbD), risk assessment, Design of Experiments (DoE) and other scientific approaches.
• Plan and execute laboratory, pilot, engineering, exhibit and scale-up batches.
• Evaluate analytical data and identify formulation or process variables affecting product performance.
• Support technology transfer and scale-up activities from laboratory to pilot and commercial scale.
• Provide technical support during exhibit, validation and commercial batches.
• Prepare and review Formulation Development Reports, protocols, risk assessments, MFR/BMR, specifications, process descriptions and other development documentation.

Candidate Profile

The ideal candidate should have:

• M. Pharm qualification from a recognized institution.
• 8–10 years of relevant experience in pharmaceutical Formulation Research & Development.
• Strong hands-on experience in Solid Oral Dosage Forms, including tablets, capsules and/or pellets.
• Experience in injectable product development will be highly preferred.
• Strong understanding of QbD, QTPP, CQA, CPP, CMA, DoE and risk assessment principles.
• Experience in formulation optimization, scale-up, exhibit batches and technology transfer.
• Knowledge of pharmaceutical development documentation and regulatory requirements.
• Strong analytical and scientific problem-solving capabilities.
• Ability to lead technical investigations and resolve formulation/process-related challenges.
• Experience in handling and mentoring junior formulation development team members.
• Strong cross-functional coordination, communication and project-management skills.