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5.0 - 15.0 years
0 Lacs
hyderabad, telangana
On-site
As a Formulations Scientist located in Hyderabad, India, you will be responsible for developing oral solid dosage forms of both Non-DEA and DEA substances. Your key functions will include conducting Literature Search, Pre-Formulation, and Formulation Design to ensure the development of stable, Bioequivalent, and Manufacturable generic solid oral formulations. Your responsibilities will involve being a mentor and motivator to your team. You will be tasked with developing robust formulations and processes for immediate release and modified release tablet and capsule dosage forms. Additionally, you will evaluate patents, develop non-infringement strategies, and have the capability of developing Paragraph IV products. You will be required to oversee the scale-up and optimization of the manufacturing process, execute pre-exhibit and exhibit batches, and handle the technology transfer from R&D to production to meet project timelines. Your role will also involve planning and contributing to project-related scientific/technical activities, authoring technical documents for regulatory filings, and interacting with API manufacturers, CROs, and CMOs as necessary. Furthermore, you will work collaboratively with cross-functional groups to execute change controls associated with Manufacturing and Packaging master records, SOPs, and protocols. You will be responsible for creating and reviewing SOPs, ensuring documentation and test results accuracy and compliance with SOPs/GMP requirements, and coordinating with Regulatory Affairs for ANDA filings and Supplements filing. To qualify for this position, you should hold a Masters degree with a minimum of 15 years of experience or a Ph.D. in Pharmacy with at least 5 years of relevant experience in oral solids product development within the generic pharmaceutical industry. Experience in Generic R&D and a successful track record of AND submissions are essential. Knowledge of modified release dosage forms is advantageous. Candidates should possess self-motivation, excellent written and verbal communication skills, as well as good interpersonal and project management skills.,
Posted 3 days ago
3.0 - 7.0 years
0 Lacs
rudrapur, uttarakhand
On-site
As a Research Associate at Naari Pharma, you will play a crucial role in the execution of formulation development activities for solid dosage forms across regulated and semi-regulated markets. Your responsibilities will include conducting literature search and pre-formulation studies, evaluating innovator/RLD products, executing R&D trial batches and scale-up activities, and preparing stability batches. You will also be responsible for documentation tasks such as preparing Master Formula Cards, Product Development Reports, and Stability Protocols, as well as supporting regulatory submissions. You will work closely with cross-functional teams to monitor scale-up and exhibit batches, troubleshoot formulation challenges, and ensure adherence to development timelines and project goals. The ideal candidate for this position should hold an M. Pharma degree in Pharmaceutics, have at least 3 years of hands-on experience in solid dosage formulation development, possess knowledge of pre-formulation, DoE, and scale-up activities, and be familiar with stability studies and regulatory documentation. Strong problem-solving skills, attention to detail, and good communication and teamwork abilities are also essential for this role. If you are passionate about advancing women's health through pharmaceutical innovation and are looking for an opportunity to contribute to a global company with a focus on hormonal therapies, we encourage you to apply for the Research Associate position at Naari Pharma.,
Posted 1 week ago
12.0 - 20.0 years
12 - 16 Lacs
Aurangabad
Work from Office
We have been hired by a highly reputed and fast growing Pharma company to hire a "DGM - Formulation & Development' to be based at their plant located at Aurangabad . Details of the position are mentioned below: Role & responsibilities: Literature search/study and to prepare development trials strategies. Pre formulation study execution. Market/Innovator/reference product characterization. Execution and documentation of trial batches for prototype formulation development. Execution and monitoring of development stability studies. Execution of process optimization/scale-up batches. Technology transfer activities at site. Preparation/review of documents like BOM, MFR, compatibility study protocol & report, stability study protocol and report, PDR, etc as per requirements. Co-ordination with production, other relevant cross-functional departments/teams. Having experience/exposure of formulation development of solid oral, liquid, dry syrup, etc dosage forms aimed for ROW and domestic market. Should possess experience in handling various equipment like RMG, FBD/FBP, compression machine, roller compactor, coating machine, etc. Preferred candidate profile : Educational Qualification: M. Pharm Experience: 12 - 20 Years of relevant experience in a leading Pharma Company. Good Communication & Presentation skills Those of you whose profile matches the above mentioned description and would like to apply for this position shall forward their updated CV to sudhirvinayak@gmail.com In case of a query, please feel free to speak to the undersigned: Sudhir Vinayak Director, Pharma Placements Inc. Mobile number: 98202 34987
Posted 3 months ago
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