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5.0 - 10.0 years

8 - 12 Lacs

navi mumbai

Work from Office

Greetings! & very warm welcome to BEST-FIT Recruitment Riders, We are BEST-FIT Recruitment Riders feel immense pleasure to search and provide you with better carrier opportunities to aid you in achieving your aspirations. BEST-FIT Recruitment Rider is a highly specialized Recruitment & Executive Search Partner for Pharmaceutical, Biotech, CRO, Chemicals, Medical Devices & Turnkey Pharma Projects Engineering-Construction Design Sectors. We are searching & recruiting highly qualified professionals for Middle-Senior-Upper-Management and Executive jobs. (Eg: Managers, VP, President, CFO & CEO). Also offering customized recruitment services by Headhunting & Executive Search for Middle & Top management level professionals according to clients specific needs. We are BEST-FIT Recruitment Riders do exactly what our name tells. To know more about us please visit our website: www.bestfitrecruitment.co.in We would like to inform you that presently we have professional career opportunity matching to your profile with one of our esteemed client. Please see the following position summary: Client Name: US based C2C Complex Formulator for USA market Position: Sr. Executive / Asst. Manager - Formulation Development (Complex Formulations) Market: USA Products: Sterile Injectable, Ophthalmic + Nasal & Inhalation Location: Navi Mumbai Job Profile: Responsible for design & development of complex sterile formulations including Sterile Injectable, Ophthalmic (Solution, Emulsion, Suspensions formulations), Nasal, Inhalation solution targeted for the USA market. Planning and conduction daily project related activities, analysing the trial outcome and further planning towards product development. To conduct pre-formulation, prototyping, formulation optimization, process development, preparation of due diligence documents and tech transfer of an injectable / sterile products aimed at US market filing. To conduct pre-formulation, prototype development, preparation of due diligence documents of ophthalmic suspensions using instruments like microfluidizer and high pressure homoginiser. The products are being developed for regulated market. To do patent searches, scientific literature searches, and associated strategies for sterile products, particularly ophthalmic products, for US markets. Execution of the developmental trial and optimization of formulation by systematic approach as per Quality by Design (QBD). Preparation and monitoring of stability protocols as per ICH guidelines and compilation of relevant stability data of development batches. Execution of the various studies like Preservative Efficacy Study, Photo stability, Thermal Stability, filterability, filter validation, filter compatibility, drop size and Short-Term Excursion Study etc. Execution scale-up & Exhibit batch of optimized formulation. Troubleshoot formulation and process-related issues during development, scale-up, & validation. Guide and mentor junior scientists, providing technical oversight and project direction. Desired Profile: M.Pharm with 5 to 10 experience in Formulation Development for USA markets especially in Sterile Formulations. Ph.D would be added advantage. Should have Good understanding of product development life cycle for Complex Sterile Formulation (Solution, Emulsion, Suspensions formulations). Exposure in Complex Sterile Formulation for USA market is must. Sterile formulation along with additional knowledge of Solid Orals, Nasal & Inhalation will give added advantage. Should have Good understanding of product development life cycle for Nasal Formulation. Prior experience in a Pharma CRO/CDMO environment is highly desirable. Should have Good understanding of product development life cycle for Complex Sterile Formulation. Person must have proficiency in operating High Pressure Homogenizer (GEA Panda, Avestin Emulsiflex C5). Strong project management, leadership, and cross-functional collaboration skills. Should have excellent communication skills with good spoken and written English. Recruiter Details: BEST - FIT Recruitment Riders G-7, Amrit Complex, Opp: Mahavir Jain Vidhyalaya & Jain Derasar, Vadodara-390001, Gujarat, India Mobile: 09722052906, 09722042906 E-Mail: career@bfrr.in Website: www.bestfitrecruitment.co.in

Posted 2 weeks ago

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2.0 - 5.0 years

2 - 4 Lacs

Ahmedabad

Work from Office

Job Title: F&D Executive Experience: 23 Years Department: Formulation & Development (F&D) Location: Prahladnagar, Ahmedabad Reporting To: F&D Manager / R&D Head Job Description: We are looking for a skilled and detail-oriented F&D Executive with 2–3 years of hands-on experience in pharmaceutical formulation development. The ideal candidate should possess a solid understanding of global regulatory guidelines (e.g., ICH, USFDA, EMA) and strong expertise in dissolution method development. The role involves supporting product formulation, optimization, and technology transfer activities in line with international quality and compliance standards. Key Responsibilities: Develop and optimize formulations for new and existing products across various dosage forms. Conduct pre-formulation studies, compatibility studies, and stability evaluations. Design and execute dissolution method development and validation as per international guidelines (USP, Ph. Eur., JP, etc.). Prepare and maintain technical documentation including MFRs, BMRs, development reports, and validation protocols. Ensure compliance with global regulatory requirements (ICH, USFDA, EMA, WHO) throughout development stages. Support scale-up, exhibit batch preparation, and technology transfer to manufacturing. Collaborate with cross-functional teams including QA, QC, Regulatory Affairs, and Production. Required Skills & Knowledge: In-depth knowledge of worldwide regulatory guidelines related to formulation and dissolution. Hands-on experience with analytical instruments and dissolution testing (e.g., USP Apparatus I & II). Familiarity with cGMP, GLP, and ICH Q8/Q9/Q10 guidelines. Strong technical writing, documentation, and data interpretation skills. Ability to work in a fast-paced, cross-functional environment with attention to detail.

Posted 3 months ago

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