MSN pharmaceutical, Piscataway, NJ-08854, USA(Analytical R&D scientist)(Currently working) -Performed analytical testing in method development & method validation. -Drafting SOP for Autosampler and Densitometer Appco Pharma, Piscataway, NJ-08854, USA (Associate Formulation Scientist) (Apr 2018- Oct 2018) -Prepared SOP's for GMP practice modification. -Identified and completed incidents by CAPA procedure as per SOP. -Prepared of cleaning verification report, cleaning verification protocol & exhibit batch sampling protocols. -Reviewed BMR, BPR, MFC, MPC, and other R&D operational documents.
- Associate Formulation Scientist at Appco Pharma
6 months at this Job
- Master in Industrial Pharmacy - Industrial Pharmacy
- Bachelor of Pharmacy - Pharmacy
• Hands on experience in formulating Semi-solid, Topical Solution and Oral Solution product Development.
• Developing complex pharmaceutical products, leading to successful ANDA filings and approval in a timely manner.
• Managing and scheduling multiple projects, setting objectives and prioritizing activities to meet the milestones in a fast pace environment.
• Preparation of product manufacturing, batch records and protocols for different product development stages, including from R&D prototype formulations to process validations following SOPs and procedures; ensuring the detailed record and data keeping.
• Characterization of APIs, excipients and in process products; analysis of in-process samples or in-process products based on protocols and QbD concept, preparing various formulation samples to support cross-functional programs as needs.
• Perform physical evaluation by using Microscopic method, pH meter, Brookfield Viscometer, Differential Scanning Calorimeters and Rheometer.
• Perform different study for new product development Drug excipient compatibility study, Thermal cycle study, Freeze and Thaw study, Bulk hold time study and Hygroscopic Study.
• Experience in Innovative approaches to solving formulations challenges and formulation technologies to improve solubility and bioavailability of poorly water-soluble drug is preferred.
• In-depth understanding of preformulation, formulation principles required to get a drug from discovery through clinical development is desirable.
• Setting-up and cleaning equipment for experiments by following the SOPs, maintaining formulation Lab in a clean and safe working environment.
• Establishing documentation management systems for product development and meeting FDA GMP, regulatory requirement and FDA onsite inspections.
• Ensuring all regulatory documents in compliance with SOPs, FDA Regulations and cGMP policy where applicable.
• Maintaining formulation development notebook document work.
• Maintaining compliance with GMP, SOPs and DEA regulations.
- Formulation Scientist at Quagen Pharmaceutical
- Formulation Scientist at InvaDerm
- Formulation Scientist and Analytical Scientist at Geritrex Corporation
2 years, 2 months at this Job
- Masters - MASTER OF BUSINESS ADMINITRATION
• Preformulation study like pH solubility, pKa & logP determination and excipients compatibility; FDA package review, literature & patent evaluation
• Formulating and developing tablets, minitabs, capsules via direct compression and granulation process
• Formulation of liquids, suspensions and injectables (conventional & complex)
• Formulaiton of functional coated controlled release beads/pellets/tablets focusing extended and delayed release using fluid bed coater
• In process testing and release testing of solid, semi/liquid dosage forms
• Proficient collaborator with cross-functional teams such as analytical, regulatory and clinical
• Design of experiments (DOE) and statistical data analysis using JMP and minitab
• Optimizing, scale up manufacturing process and make tech-transfers
• Experienced in manufacturing ANDA/NDA submittsion batches, Phase I/II clinical trial batches under cGMP conditions.
• Expert in writing technical protocals, develeopment batch manufacturing record (DBMR) and product development/tech-transfer report
- Formulation Scientist at Frontida Biopharm
2 years, 7 months at this Job
- Doctorate - Chemcial Engineering
The main focus of my activities include formulation of new fertilizers programs, providing chemical and troubleshooting support for production, quality control, biology, and technical service division.. Formulation duties encompass coordination with marketing and sales to determine market potential, identification of vendors for raw materials and qualification for use and coordination of supply chain for annual production requirements, paper and bench formulations, cost analysis, physical and chemical properties studies, multi-national regulatory compliance, coordination with biology for research trials, coordination with QC for plant production, and coordination with packaging engineers for final product wrap-up. Other projects have included migration of raw material and formulas between ERP systems, reformulation of current products to ensure multi-national regulatory compliance, new material qualification, evaluation of vendors, product lines, and technology for consideration, collaboration with QC and EH&S department for solving analytical and chemical issues, development of user-friendly calculation tools of all products and programs for use by biology, R&D, and tech service departments.
- Formulation Scientist at Hawthorne Gardening Company
- Lab Manager/Research Scientist at Full Cycle Bioplastics
- Professor of Chemistry - Adjunct at Diablo Valley College
- Chemistry Instructor - Adjunct at College of Marin
2 years, 2 months at this Job
- M.S. - Chemistry
- B.S. - Chemistry
FDA regulated medical R&D facility * Plan and conduct research to develop new or improved product formulas for photothermographic medical imaging film and nano material transparent conductive film (TCF) * 10 years experience in formulating multi-layer, multiple polymer solutions, in solvent and aqueous systems * Prepare laboratory scale batches of prototype product and maintain records for future reference * Organize and conduct physical property testing of new and aged films for evaluation * Execute data entry and data management tasks * Analyze data to present to team members and management in timely fashion * Assist team members in analyzing or collecting data * Participate in new formulation scale-up from laboratory to manufacturing * Provide technical support for manufacturing scale up * Knowledge of thin film roll-to-roll coating: gravure, slide, and slot die * Familiar with common laboratory operations with knowledge of design of experiment (DoE) planning
FDA regulated medical R&D facility
* Plan and conduct research to develop new or improved product formulas for photothermographic medical imaging film and nano material transparent conductive film (TCF)
* 10 years experience in formulating multi-layer, multiple polymer solutions, in solvent and aqueous systems
* Prepare laboratory scale batches of prototype product and maintain records for future reference
* Organize and conduct physical property testing of new and aged films for evaluation
* Execute data entry and data management tasks
* Analyze data to present to team members and management in timely fashion
* Assist team members in analyzing or collecting data
* Participate in new formulation scale-up from laboratory to manufacturing
* Provide technical support for manufacturing scale up
* Knowledge of thin film roll-to-roll coating: gravure, slide, and slot die
* Familiar with common laboratory operations with knowledge of design of experiment (DoE) planning
- Formulation Scientist at Carestream Health
16 years, 4 months at this Job
- Bachelor of Science - Mathematics
- Bachelor of Science - Astrophysics
- Associate in Arts
• Formulate Oral Solid, Liquid Dosage forms and powder for oral suspension
• Majority working with ANDA project
• Worked on tough Liquid projects
• In-Charge for the execution of Pilot and Submission batches
• Troubleshoot problems related to formulation and ensure formulations run flowless on production scale
• Performed process-related investigations, identify root causes of process/manufacturing discrepancies, evaluated systems for trends and adverse findings, and implement appropriate steps to ensure process robustness.
• Performed formulation stability studies including but not limited to pilot stability studies with proposed drug product configuration, contact material compatibility and stability study, in-use compatibility study, accelerated stability studies, etc.
• Create and review all type of documentation activity
• Knowledge of Batch manufacturing protocols, Stability protocols, Hold time protocols and Sampling protocols
• Maintained proper documentation of all experimental procedures and results, including batch records, protocols, Standard Operating Procedures (SOPs) and other manufacturing related documentation
• Manufacture pilot batches, Process optimization for scale-up to production
• Perform other job duties related to job as assigned by Management
• Do proper time management and communicate with other departments to make the product development smooth and efficient
• Equipment used: High Shear Granulator, Fluid Bed, Homogenizer, Roller Compactor, Compression Machine, Bi-layer compression Machine, Tablet Coating, Packaging Machine for Powder, Tablet, Capsules as well as Liquid
• Provided qualified input and development support for plans and study protocols
• Helped team to meet regulatory requirements by coordinating documentation
- FORMULATION SCIENTIST at MSN PHARMACEUTICALS
1 year, 1 month at this Job
- MASTER OF INDUSTRIAL PHARMACY - Industrial and Physical Pharmacy and Cosmetic Sciences
- BACHELOR OF PHARMACY - Pharmaceutics, Dosage form design, Medicinal Chemistry
•Design and development of formulations for new drug products focusing on oral solid dosage forms.
• Optimisation of formulation by experimental design, product testing, and trouble shooting.
• Writing of CGMP manufacturing batch records, stability protocols, and product reports.
• Effectively communivating with others departments such as ARD, Quality, Pharmacokinetics, and Regulatory Affairs.
•Remaining current with GMP regulations by attending SOP, seminars, and trainings.
- Formulation Scientist at Frontida BioPharm, Inc
- Analytical Scientist at
- at Postdoctoral Fellowship
- at Postdoctoral Fellowship
8 months at this Job
- Doctor of Philosophy - Statistics
- Bachelor of Science (honours) - Biology
- Formulation scientist at Saptalis pharmaceuticals LLC
3 years, 4 months at this Job
o Performed initial client assessment and analysis to begin research process. o Responsible for generating new techniques, chemical patterns, and procedures for finding out appropriate resolutions for technical issues. o Engineered and tasked with directly developing new products for clients. o Provided advice on research and development options available in the organization. o Suggested recommendations related to the development of product and service. o Proved ability to prioritize work and effectively multitask between different projects.
- Formulation Scientist at Solara Inc
- Spa Sales Associate at
9 months at this Job
- Completing a Master's in Healthcare Service Administration
- Bachelor of Science - Biology
• Planned and performed laboratory experiments to develop and optimize formulations and manufacturing processes.
• Profiling physico-chemical properties of compounds.
• Formulated and developed liquid dosage forms including immediate and sustained release products.
• Planned and executed stability studies and excipient compatibility studies.
• Created formulas, gathered and inspected raw materials and equipments, developed processes, supervised/ made scale-up, test and production batches.
• Attended brainstorming meetings to support and update progress on new formulations.
• Prepared and submitted product development reports to FDA for various approvals.
• Reviewed and approved the final release of raw materials, packing materials, in-process and finished products
• Co-ordinated with Regulatory Affairs for submissions and approvals from FDA.
- Formulation Scientist at Tris Pharma
- Regulatory Affairs Supervisor at Medisal Pharmaceuticals
- Formulation Scientist at
- Teaching assistant at St. John's University
4 years, 10 months at this Job
- Master of Science - Pharmaceutical Sciences
- Bachelor of Pharmaceutical Sciences