Atul Patel
Summary
Results-oriented Pharmaceutical Development Scientist with over 20 years in developing safe and effective pharmaceuticals and supplements. Expertise in generic and OTC/ANDA solid oral dosage formulations, including tablets and capsules. Skilled in product and process development, Clinical Trial Material management, and Technology Transfer. Proven project management and leadership capabilities, driving teams to achieve project goals efficiently.
Overview
42
42
years of professional experience
Work History
Director, Technical Operation
US PHARMA LAB
NEW JERSEY
04.2019 - Current
- Developed and optimized new formulations and improved existing formulations to enhance product performance.
- Writing and executing Scale up, Process Qualification and Process Validation Protocols.
- Executed wet and dry granulation processes to produce high-quality formulations.
- Oversaw compression of multi-layered and chewable products to ensure consistency.
- Managed encapsulation processes for hard shell and capsule-in-capsule formulations.
- Conducted pellet coating processes to enhance product performance.
- Streamlined manufacturing processes to enhance workflow efficiency.
Sr. Formulation Scientist, R&D (Orals)
AUROBINDO PHARMA
NEW JERSEY
02.2017 - 03.2019
- Led key R&D projects team that planned and developed multiple projects related to solid oral dosage generic drug products.
- Developed controlled release, enteric coated, and bi-layer solid dosage formulations.
- Developed control release, enteric coated and bi-layer solid dosage.
- Collaborated with regulatory and quality teams to ensure compliance.
Product & Process Development Technology, Sr. Scientist
BAYER HEALTH CARE
PENNSYLVANIA
05.2010 - 01.2017
- Contributed as a key member of the Process Technology team to plan and develop multiple projects related to solid dosage, including the development and process optimization of new formulations and improvement of existing formulations.
- Managed internal product development, overseeing production scale-up and validation through effective project management.
- Oversaw daily pilot plant operations to ensure efficiency and safety.
- Support manufacturing with shop floor activities and related issues on a daily as needed basis.
Director, Formulation Development
SCOLR PHARMA, INC.
BOTHELL
10.2006 - 04.2010
- Oversee development of new formulation and process development for Rx and OTC drug product.
- Led team of scientists in formulation development program focused on ANDA, NDA, and OTC products.
- Played key role in company’s first ANDA and NDA filing.
- Supported NDA and ANDA submission activity through internal regulatory department.
- Communicated project updates to Chief Scientific Officer.
- Contributed significantly to successful submission of company’s first ANDA and NDA.
- Wrote Pharmaceutical Development Report and CMC Section.
- Supported pilot PK and efficacy clinical trials.
- Recommended and Identified contract manufacturing and testing sites.
- Attended Pre-IND meeting and teleconference with FDA.
- Participated in Pre-IND meeting and teleconference with FDA to discuss regulatory requirements.
Director, Research and Development
Leiner Health Products
FORT MILL
01.1999 - 10.2006
- Oversaw development and process optimization of new and existing formulations, enhancing product quality and market readiness.
- Manage internal product development through production scale-up and validation via project management and matrix organization systems.
- Managed internal product development with production scale-up and validation through project management and matrix organization, ensuring timely project delivery.
- Lead technology transfer projects.
- Successfully initiated and executed Product Development Report based on ICH Q8 guideline for all products.
- Played key role in design and implementation of PAT program.
- Supported ANDA filings for various products.
- Led technology transfer projects.
- Set up R&D pilot lab and infrastructure.
Senior Formulation Scientist, Research and Development
Nature’s Products, Inc.
SUNRISE
05.1997 - 01.1999
- Developed formulations for new solid dosage forms, tablets, and capsules.
- Designed and equipped development laboratory, contributing to successful start-up of new manufacturing plant.
- Created and executed pilot and scale-up batches, including scale-up protocols and master batch record, ensuring smooth transition to production.
- Designed and equipped new development laboratory and played key role in start-up of new manufacturing plant.
- Established R&D lab and authored SOPs, setting standards for operational consistency and compliance.
Senior Formulation Scientist, Research and Development
Rexall Sundown, Inc.
BOCA RATON
06.1995 - 04.1997
- Utilized innovative problem solving techniques in development of solid dosage nutritional supplements to create one of Rexall’s best-selling products.
- Optimized and reformulated processes and products, enhancing overall product quality and performance.
- Provided technical support to contract manufacturers.
- Authored product development reports and conducted cost analysis to inform strategic decision-making.
- Wrote product development reports and performed cost analysis.
- Provided technical support to contract manufactures.
Section Head, Research and Development
Laboratory & Allied, Ltd.
NAIROBI
05.1984 - 06.1990
- Planned and executed product development activities of generic prescription products for largest developer and manufacturer of niche generic products in East Africa.
- Instituted strategies for raw material sourcing and formulation development to replicate reference products, including tablets, capsules, liquids, creams, and ointments, enhancing product alignment with industry standards.
- Implemented start-up of SOP, cGMP, and WHO documentation functions to ensure compliance with regulatory requirements and streamline operational processes.
- Executed pilot batches and screened compounds for physical properties, contributing to formulation efficiency and product quality assessment.
- Implemented start-up of SOP, cGMP and WHO documentation functions.
Education
Master of Science - Chemistry
Sardar Patel University
Vidyanagar, IndiaAssociations
- American Association of Pharmaceutical Scientists (AAPS)
- International Society for Pharmaceutical Engineers (ISPE)
Qualifications Summary
- American Association of Pharmaceutical Scientists (AAPS)
- International Society for Pharmaceutical Engineers (ISPE)
Timeline
Director, Technical Operation
US PHARMA LAB
04.2019 - Current
Sr. Formulation Scientist, R&D (Orals)
AUROBINDO PHARMA
02.2017 - 03.2019
Product & Process Development Technology, Sr. Scientist
BAYER HEALTH CARE
05.2010 - 01.2017
Director, Formulation Development
SCOLR PHARMA, INC.
10.2006 - 04.2010
Director, Research and Development
Leiner Health Products
01.1999 - 10.2006
Senior Formulation Scientist, Research and Development
Nature’s Products, Inc.
05.1997 - 01.1999
Senior Formulation Scientist, Research and Development
Rexall Sundown, Inc.
06.1995 - 04.1997
Section Head, Research and Development
Laboratory & Allied, Ltd.
05.1984 - 06.1990
Master of Science - Chemistry
Sardar Patel University