Senior Research

Akums Drugs & Pharmaceuticals Limited; Haridwar; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

Akums Drugs & Pharmaceuticals Limited is seeking a Manager/Senior Manager in Haridwar to lead end-to-end formulation development for multiple dosage forms. You will oversee lab trials, stability studies, technology transfer, and documentation, while ensuring regulatory alignment and project delivery.

The role requires strong leadership, hands-on expertise in formulation development, and a track record of driving scale-up and cost-effective processes within GMP environments.

Qualifications

• Postgraduate qualification in formulation development or related R&D function.
• Experience in pharma/nutraceutical formulation development across multiple dosage forms.
• Exposure to regulatory documentation, technology transfer and scale-up.

Responsibilities

• Lead formulation development activities for tablets, capsules, liquids, softgels, powders, sachets and gummies.
• Coordinate stability studies, GLP compliance, and documentation.
• Drive technology transfer to manufacturing with robust, reproducible processes.
• Mentor and develop R&D team members and ensure timely project delivery.
• Support regulatory submissions and ensure alignment with FSSAI, AYUSH, ICH where applicable.

Skills

Formulation development

Regulatory coordination

Team leadership

Project management

Documentation

Quality systems

GLP compliance

Scale-up

Technology transfer

Problem solving

Education

M. Pharm / M.Sc.

Tools

SAP

Job description

Position Details

Job Title: Manager / Sr. Manager / AGM Formulation Development

Location: Haridwar

Function: Research & Development Formulation Development

Reporting To: Head R&D / Formulation Development

Job Purpose

To lead and manage formulation development activities for various dosage forms in accordance with applicable regulatory requirements, quality standards, development protocols, and organizational objectives.

The position will be responsible for end-to-end formulation development, laboratory trials, stability studies, technology transfer, documentation, troubleshooting, cost optimization, regulatory coordination, and team development.

The incumbent will also contribute to the development of innovative products in line with market requirements and ensure timely delivery of R&D projects from concept through technology transfer and commercialization.

Key Responsibilities

A. Formulation Development

1. Initiate and lead formulation development activities for various dosage forms, including:
   • Tablets
   • Capsules
   • Liquids
   • Softgels
   • Protein powders
   • Sachets
   • Gummies and other nutraceutical/healthcare dosage forms, as applicable.
2. Evaluate market requirements, product concepts, customer requirements, and feasibility for development of new products.
3. Develop robust formulations and manufacturing processes in accordance with applicable regulatory requirements and internal R&D procedures.
4. Plan and execute laboratory trials, optimization studies, comparative studies, and formulation/process experiments.
5. Develop formulations in compliance with applicable FSSAI, AYUSH, and other relevant statutory/regulatory requirements.
6. Keep abreast of emerging technologies, dosage forms, ingredients, excipients, processing techniques, and market trends relevant to formulation development.

B. Laboratory Trials & Development Activities

1. Conduct laboratory experiments as per approved development protocols and document observations, results, conclusions, and recommendations.
2. Analyze experimental results and identify appropriate formulation/process optimization strategies.
3. Prepare development reports with scientific conclusions, recommendations, and further action plans.
4. Ensure proper utilization, maintenance, and upkeep of formulation development laboratory facilities, instruments, and equipment.
5. Ensure adherence to GLP, laboratory practices, safety requirements, and applicable departmental SOPs.

C. Stability Studies

1. Plan and initiate stability studies in accordance with applicable ICH guidelines, regulatory requirements, and R&D stability SOPs.
2. Review stability data periodically to identify trends, failures, deviations, or potential product-related issues at an early stage.
3. Coordinate with relevant departments for investigation and corrective actions in case of stability failures or atypical results.
4. Prepare and review stability protocols, stability summaries, reports, and related documentation.

D. Technology Transfer & Scale-Up

1. Prepare, review, and finalize technology transfer documents, including:
   • Master Formula Record (MFR)
   • Bill of Materials (BOM)
   • Process/manufacturing instructions
   • Technology transfer protocols and related documents.
2. Coordinate and execute technology transfer activities at the respective manufacturing site.
3. Support and monitor technology transfer/scale-up activities for three consecutive batches, as applicable.
4. Resolve formulation and process-related issues encountered during scale-up and commercial manufacturing.
5. Ensure that the transferred process is reproducible, robust, and aligned with the approved development data.

E. Product Development Documentation

1. Prepare and review product development documents, including:
   • LNB
   • Product Development Report (PDR)
   • Raw Material COA evaluation
   • Stability Summary Report
   • Validation Batch Reports
   • Development protocols and reports
   • Other relevant R&D documents.
2. Ensure that all product development documentation is accurate, complete, traceable, and prepared within defined timelines.
3. Maintain proper records of formulation trials, experimental observations, raw material evaluations, development history, and product-related technical information.

F. Packaging & Artwork Coordination

1. Review product artwork and packaging information from a technical/formulation perspective.
2. Provide and verify relevant product details required by the Packaging Development team.
3. Coordinate with Packaging Development and other concerned functions to ensure timely finalization of packaging components and artwork.

G. Troubleshooting & Process Improvement

1. Provide technical support for troubleshooting formulation and manufacturing-related problems in existing products.
2. Support manufacturing process improvement initiatives to enhance product quality, process efficiency, yield, and reproducibility.
3. Identify and implement opportunities for:
   • Cost optimization
   • Process optimization
   • Solvent reduction/removal
   • Yield improvement
   • Raw material optimization
   • Manufacturing efficiency improvement.
4. Conduct technical evaluations and recommend appropriate corrective and preventive actions for formulation/process-related issues.

H. Costing & Material Planning

1. Prepare tentative costing and BOM for newly developed products.
2. Evaluate raw materials, excipients, packaging requirements, and other development inputs from a technical and commercial feasibility perspective.
3. Generate material requests and purchase indents through SAP as per project requirements.
4. Coordinate with Plant Stores and Purchase/Procurement departments to ensure timely availability of materials required for formulation development activities.

I. Regulatory & Licensing Support

1. Ensure timely submission of required product development documents and technical information to the Regulatory Affairs team.
2. Coordinate effectively with Regulatory Affairs and other concerned departments for documentation requirements related to licensing and regulatory submissions.
3. Ensure that formulation development activities and documentation are aligned with applicable FSSAI, AYUSH, ICH, and other relevant regulatory requirements.
4. Monitor regulatory updates and assess their impact on ongoing and future product development activities.

J. Team Leadership & People Development

1. Lead and supervise the formulation development team to achieve project objectives within defined timelines.
2. Allocate development activities to team members based on project priorities, competencies, and workload.
3. Review the performance and technical output of team members and provide appropriate guidance and mentoring.
4. Develop a capable second line of team members who can independently manage formulation development activities in the absence of the incumbent.
5. Encourage technical learning, innovation, problem-solving, and continuous improvement within the team.

K. Coordination & Communication

1. Maintain timely communication with the Head of Department regarding:
   • Project status
   • Formulation development progress
   • Raw material research
   • Experimental results
   • Stability results
   • Technical issues
   • Project timelines and risks.
2. Ensure effective inter-departmental and intra-departmental coordination with Manufacturing, Quality Assurance, Quality Control, Regulatory Affairs, Packaging Development, Purchase, Stores, and other relevant functions.
3. Ensure timely escalation of critical technical issues, project delays, deviations, and development risks to the appropriate management level.

L. Compliance, Safety & Quality

1. Ensure strict adherence to GLP, departmental SOPs, safety procedures, quality systems, and applicable regulatory requirements.
2. Ensure proper maintenance and housekeeping of the formulation development laboratory.
3. Promote a strong culture of quality, safety, documentation, compliance, and scientific integrity within the department.
4. Participate in audits, investigations, CAPA activities, and other quality/compliance initiatives as required.

M. Continuous Improvement & Innovation

1. Keep abreast of current trends, technologies, market developments, scientific practices, and regulatory changes related to formulation development.
2. Identify new opportunities for product development, process improvement, cost reduction, and technology enhancement.
3. Support innovation and development of differentiated products based on market needs and organizational strategy.
4. Take ownership of new assignments and special projects entrusted by management and ensure their timely and effective completion.

Key Competencies

• Strong knowledge of pharmaceutical/nutraceutical formulation development.
• Sound understanding of FSSAI and AYUSH requirements.
• Knowledge of ICH stability requirements and R&D stability practices.
• Strong analytical and problem-solving skills.
• Good understanding of scale-up and technology transfer.
• Strong documentation and report-writing skills.
• Ability to troubleshoot formulation and manufacturing problems.
• Project planning and execution capability.
• Team leadership and people-management skills.
• Good communication and inter-departmental coordination skills.
• Ability to prioritize multiple projects and meet timelines.
• Knowledge of SAP for material requests/purchase indent activities will be an advantage.
• Strong focus on quality, compliance, safety, and continuous improvement.

Educational Qualification

M. Pharm / M.Sc. / relevant postgraduate qualification with specialization or experience in formulation development, nutraceuticals, or related R&D functions.

Experience

Relevant experience in pharmaceutical/nutraceutical formulation development, preferably with exposure to multiple dosage forms such as tablets, capsules, liquids, softgels, powders, sachets, and gummies.

Experience in technology transfer, scale-up, stability studies, regulatory documentation, troubleshooting, and team handling will be preferred.

Key Performance Indicators (KPIs)

• Timely completion of formulation development projects.
• Successful development of robust and scalable formulations.
• First-time-right formulation/process development.
• Successful technology transfer and scale-up.
• Stability study compliance and timely review of stability data.
• Timely completion of R&D documentation.
• Cost optimization and process improvement initiatives.
• Timely regulatory documentation support.
• Effective management and development of the R&D team.
• Compliance with GLP, SOPs, safety, and regulatory requirements.
• Reduction in development failures, deviations, and transfer-related issues.
• Successful launch/transfer of products as per agreed project timelines.