AM -FRD (Complex Injectable) For USA Market, Mumbai

Job Description

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: Asst. Manager - FRD ( Complex Injectable )
• Market: USA
• Products: Sterile Formulations Parenteral, Ophthalmic Suspensions, Ophthalmic Solution, Ophthalmic Emulsion, Cream, Nasal, Inhalation Solution
• Location: Mahape, Navi Mumbai

Job Profile:

• 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 micro fluidizer and high pressure. The products are being developed for regulated market.
• To conduct scientific literature search, patent search & related strategy for sterile products especially Ophthalmic 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 and Exhibit batch of optimized formulation.

Desired Profile:

• M.Pharma / Ph.D. in Pharmaceutics, Formulation Science, Industrial Pharmacy, or a related field.
• 5 to 10 years of experience in Pharmaceutical R&D for regulated markets (USA), with strong exposure to sterile injectable, ophthalmic, Nasal.
• Exposure in Microspheres & Peptide would be added advantage.
• Experience in new product development, with strong expertise in sterile products for regulated markets.
• Hands-on experience with modern product development equipment and exposure to technology transfer processes
• Proven ability to handle advanced equipment and support scale-up and tech transfer activities.
• Business acumen with ability to align R&D strategy to organizational growth.
• Interaction with CROs and CMOs as needed.
• Will be ready to travel in India & abroad for Technology Transfer & Exhibit Batches whenever require.
• Skills in ensuring product delivery on target timelines.
• Ability to maintain confidentiality requirements of the position.
• Must be able to design innovative strategies & achieve goals in defined timelines.
• Tactful be able to handle sensitive/ unpleasant situations.
• Excellent stakeholder-management abilities.
• Exceptional leadership, cross-functional management, and project management capabilities.
• Excellent leadership, communication, and cross-functional collaboration capabilities.
• Strong verbal and written communication skills in English.

Good to have: Instruments proficiency as below:

• Experience in PLGA-based microsphere injections and peptide formulations
• Exposure to solid dosage manufacturing equipment: tablet compression machine, rapid mixer granulator (RMG), fluidized bed dryer (FBD), roller compactor, coating machine, sieve shaker, hardness tester, disintegration apparatus
• Experience with homogenization systems: high shear homogenizer (IKA), high pressure homogenizers (GEA Panda, Avestin Emulsiflex C5), micro fluidizer (Microfluidics).
• Familiarity with analytical instruments: ohmmeter, pH meter, dissolved oxygen (DO) meter, Brookfield viscometer.
• Experience with particle size and zeta potential analysis: Malvern Zetasizer (Nano ZS90), Malvern Mastersizer 2000/3000.

Recruiter Contact Details:

BEST - FIT Recruitment Riders

G-7, Amrit Complex,

Opp: Mahavir Jain Vidhyalaya & Jain Derasar,

R.V. Desai Road, Near Goyagate Circle,

Vadodara-390001, Gujarat, India

Mobile: 09722052906, 09722042906

E-Mail: career@bfrr.in

Website: www.bestfitrecruitment.co.in

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