Mihir Mandaliya
Formulation And Development Scientist
Ahmedabad
Summary
Results-driven Formulation and Development (F&D) professional with extensive hands-on experience in pharmaceutical product development, equipment qualification (IQ/OQ/PQ), and regulatory documentation. Expertise in evaluating APIs and excipient for technical feasibility, crafting formulation strategies that support business development, and preparing SOPs and protocols in strict adherence to regulatory standards. Proven ability to coordinate with vendors, execute FAT, and collaborate across functions to ensure timely project delivery. Recognized for strong analytical thinking, adept problem-solving skills, and effective communication in fast-paced environments.
Overview
4
4
years of professional experience
2
2
Certifications
3
3
Languages
Work History
Senior Executive
Molkem Labs (Greenfield Project)
05.2025 - Current
- Led formulation development initiatives as a senior executive in the Formulation & Development (F&D) department, ensuring alignment with project and business objectives.
- Provided technical support to business development activities, including feasibility assessments, and formulation strategy inputs.
- Executed and documented IQ, OQ, and PQ activities, along with the preparation of protocols and SOPs in compliance with regulatory standards.
- Managed vendor coordination for equipment selection, technical evaluations, and Factory Acceptance Testing (FAT).
- Performed a technical evaluation of APIs and excipient, ensuring suitability based on quality, compatibility, and regulatory requirements.
- Prepared, reviewed, and maintained development documentation to meet client expectations and project deliverables.
- Demonstrated strong communication and cross-functional collaboration skills , ensuring smooth coordination between internal teams and external stakeholders.
Officer
APDM Pharma (Greenfield Project)
06.2024 - 05.2025
- Optimized workflow through strategic planning of production activities to achieve targets.
- Coordinated execution of a greenfield pharma project with multiple equipment and service vendors.
- Managed vendor negotiations, FAT activities, and technical clarifications for granulation, compression, capsule, and packing lines.
- Conducted quotation comparisons and facilitated costing discussions using internal systems.
- Prepared and reviewed DQ, IQ, OQ, PQ, and FAT protocols to support audit readiness and compliance.
- Served as the primary coordination point among engineering, QA, production, and vendors to ensure project progress.
- Coordinated cross-functional teams to address complex issues, leading to more efficient problem-solving processes.
Officer
Intas Pharma
07.2023 - 07.2024
- Executed granulation operations in oncology manufacturing while adhering to GMP standards.
- Supported scale-up and routine production within regulated manufacturing environments.
- Collaborated with cross-functional teams, enhancing operational efficiency and communication.
- Managed manpower and allocated tasks to optimize workflow.
- Performed documentation tasks such as E-BMR, log records, and sieve destruction.
- Processed BPCR requests through SAP to ensure compliance.
Trainee Officer To Officer
Corona Remedies
12.2021 - 07.2024
- Acquired comprehensive knowledge of all production stage activities as a trainee and Officer.
- Gained expertise in granulation, compression, coating, and capsule filling processes.
- Developed strong understanding of end-to-end pharmaceutical production operations.
- Supported documentation and batch execution to ensure compliance and efficiency.
Education
B.Pharma -
RK University
Rajkot07-2024
Skills
Pharmaceutics and formulation development
Production optimization and Qualification execution
Pharmaceutical manufacturing and compliance documentation
Vendor negotiations and project management
Computer skills
Friendly, positive attitude
Microsoft office
Data entry
Certification
Company Internship
Timeline
Senior Executive
Molkem Labs (Greenfield Project)
05.2025 - Current
Officer
APDM Pharma (Greenfield Project)
06.2024 - 05.2025
Officer
Intas Pharma
07.2023 - 07.2024
Trainee Officer To Officer
Corona Remedies
12.2021 - 07.2024
B.Pharma -
RK University