AM - Formulation Development (Complex Formulations), USA based Co.

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