Greetings! & very warm welcome to BEST-FIT Recruitment Riders,
highly specialized Recruitment & Executive Search Partner for Pharmaceutical, Biotech, CRO, Chemicals, Medical Devices & Turnkey Pharma Projects Engineering-Construction Design Sectors.
professional career opportunity
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