GNT Group
Website:
exberry.com
Job details:
About This Job
GNT Page Private Limited
Location: Ahmedabad, Gujarat, India
Work Mode: On-site
Industry: Pharmaceutical Manufacturing
Job Description
A ) Job Description - Formulation & Development Manager
Location: Bavla / Ahmedabad, Gujarat, India
Department: Formulation & Development / Pharmaceutical Development Centre
Reports to: VP Operations
Interfaces: QA, Regulatory Affairs, Production, Engineering, Procurement, Supply Chain, Technology Transfer,
The Formulation & Development Manager will be responsible for leading the formulation and pharmaceutical development activities of the company’s manufacturing site in India.
The role covers the full development cycle of generic pharmaceutical products, from literature and regulatory review, pre-formulation studies, excipient selection and formulation trials, through to process development, scale-up, technology transfer, documentation and support to regulatory submissions.
The position is intended for a strong pharmaceutical development professional able to combine scientific expertise, practical manufacturing knowledge, EU-GMP awareness and regulatory documentation discipline. The successful candidate will play a key role in building a robust Formulation & Development function capable of developing products that can ultimately be manufactured at commercial scale in compliance with Indian, African and European regulatory expectations.
The main purpose of the role is to develop robust, reproducible and regulatory-compliant pharmaceutical formulations for generic products, ensuring that each product is scientifically justified, properly documented, technically transferable and suitable for commercial manufacturing.
- Main Responsibilities
- Pharmaceutical Development Strategy
Lead formulation and development activities for new generic pharmaceutical products intended for commercial production at the Indian site.Define the development strategy for each product in coordination with Regulatory Affairs, QA, QC and Production.Review reference products, available literature, pharmacopoeias, regulatory guidelines and market requirements.Establish the Quality Target Product Profile for each product.Ensure that product development is aligned with future regulatory requirements, including CTD expectations and EU compliance where relevant.
- Pre-formulation and Formulation Development
Plan and supervise pre-formulation studies, including API characterization, excipient compatibility, solubility, stability, flow properties, compressibility and other relevant technical evaluations.Select appropriate excipients and justify their use from a scientific, regulatory and manufacturability perspective.Design formulation trials and development batches.Evaluate different manufacturing approaches, such as direct compression, wet granulation, dry granulation, coating, encapsulation or other relevant processes.Optimise formulations to ensure quality, stability, bioavailability, manufacturability and cost-effectiveness.Ensure that developed formulations are robust enough for scale-up and routine commercial production.Coordinate with Procurement and Supply Chain for the sourcing and qualification of APIs, excipients and development materials.
- Process Development, Scale-Up and Technology Transfer
Develop manufacturing processes suitable for pilot, exhibit and commercial batches.Define process parameters and in-process controls.Support scale-up from laboratory batches to pilot batches and commercial manufacturing batches.Prepare and review master formulas, development batch records, process development reports and scale-up reports.Work closely with Production, QA, QC and Engineering to ensure that development processes can be transferred effectively to manufacturing.Support process validation strategy and provide technical input for validation protocols and reports.Participate in troubleshooting during scale-up, exhibit batch manufacturing, validation batches and initial commercial production.
- Development Laboratory and Equipment Management
Support the establishment, organisation and proper functioning of the Formulation & Development laboratory.Define the equipment required for pharmaceutical development activities, such as mixers, granulators, fluid bed processors, tablet presses, coating pans, capsule filling equipment and other relevant pilot-scale or laboratory-scale equipment.Ensure appropriate qualification, calibration, maintenance and use of development equipment.Prepare or review SOPs related to formulation development activities, equipment use, cleaning, documentation and laboratory practices.Ensure safe, compliant and efficient use of materials, equipment and facilities within the development laboratory.
- Regulatory Documentation and CTD Support
Prepare, review or contribute to pharmaceutical development documentation required for regulatory submissions.Draft or support the preparation of CTD Module 3 sections, especially:3.2.P.1 Description and Composition of the Drug Product;3.2.P.2 Pharmaceutical Development;3.2.P.3 Manufacture;3.2.P.4 Control of Excipients;3.2.P.5 Control of Drug Product;3.2.P.8 Stability.Prepare product development reports, formulation rationale, process development reports, risk assessments, comparative dissolution reports and technical justifications.Support Regulatory Affairs in responding to deficiency letters, authority questions or technical queries.Ensure that documentation is complete, scientifically sound, traceable and aligned with applicable regulatory expectations.
- Team Leadership and Cross-Functional Coordination
Build, lead and develop the Formulation & Development team.Train junior formulation scientists, officers and technical staff.Allocate projects, define priorities and monitor timelines.Coordinate product development projects with Regulatory Affairs, QA, QC, Production, Procurement and Supply Chain.Provide regular updates to management on project progress, risks, delays, technical challenges and resource requirements.Act as the technical owner for formulation development projects until successful transfer to routine manufacturing.
The Formulation & Development Manager will be expected to deliver:
approved development plans for each product;literature and regulatory review summaries;pre-formulation study reports;formulation trial protocols and reports;development batch records;process development and scale-up reports;formulation rationale and excipient justification;risk assessments and control strategy proposals;CTD pharmaceutical development documentation;stability and comparative dissolution support documents;technology transfer packages;technical input for validation, registration and inspection readiness.
B ) Candidate Requirement
Master’s degree or PhD in Pharmacy, Pharmaceutical Sciences, Pharmaceutics, Industrial Pharmacy, Pharmaceutical Technology or a related scientific discipline.Minimum 8–12 years of experience in formulation development within the pharmaceutical industry.Strong experience in generic product development, preferably for oral solid dosage forms.Previous experience in a GMP-regulated manufacturing environment.Experience with scale-up, exhibit batches, process validation support and technology transfer.Good understanding of regulatory documentation requirements for generic products.Prior exposure to EU-GMP, WHO-GMP, PIC/S or regulated market expectations is strongly preferred.
- Required Technical Expertise
The Candidate Should Have Strong Knowledge Of
pre-formulation studies;excipient compatibility;formulation development of generic products;oral solid dosage forms, including tablets, capsules, granules and coated products;manufacturing processes such as blending, granulation, compression, coating and encapsulation;dissolution development and comparative dissolution requirements;stability studies and ICH stability principles;pharmacopoeial requirements, including Ph. Eur., USP, IP and BP where relevant;CTD Module 3 structure and pharmaceutical development documentation;Quality by Design principles;critical quality attributes and critical process parameters;risk assessment tools such as FMEA;process scale-up and technology transfer;GMP documentation and data integrity principles.
Experience in developing products for regulated or semi-regulated markets.Experience with EU, WHO, African or emerging market regulatory submissions.Experience in developing products for site transfer or double sourcing.Experience with bioequivalence-driven generic development.Experience in coordinating with external CROs, analytical laboratories, API suppliers and excipient suppliers.Experience in setting up or upgrading a formulation development laboratory.Experience in working with cross-functional international teams.
Strong scientific and technical judgment.Practical understanding of industrial manufacturing constraints.High level of documentation discipline.Ability to translate scientific development work into regulatory-ready documentation.Strong problem-solving and troubleshooting skills.Ability to work under project timelines and regulatory pressure.Strong communication skills with QA, QC, RA and Production teams.Leadership capability and ability to develop a technical team.Rigour, reliability and attention to detail.Pragmatic mindset: able to balance scientific ideal, regulatory compliance, manufacturing feasibility and commercial reality.
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