FR&D Complex Injectables

From 2 to 7 year(s) of experience
₹ Not Disclosed by Recruiter
Posted: 11 days agoOpenings: 5Job Applicants: 141Job Views: 666

Job Description

Role & responsibilities


FRD-Complex Injectable:


Literature review for product development for US/ EU/ ROW market especially complex injectable s like Liposomes, Nanoparticle suspension, Microspheres, Suspensions, Emulsion’s, Lyophilized products, Peptide Injectable’s, Drug delivery systems.

II) Assist in Product development activities for Complex injectable’s including:

  • Execution of Lab trials with required documentation.
  • Stock maintenance with follow-up for procurement of packaging material, Excipients, API, etc.
  • Lab equipment calibration and maintenance in co-ordination with QA/Engineering team.
  • Preparation of study protocols including stability, photo, thermal, scale up study protocol with report as per ICH guidelines.
  • Perform stability studies, Photo stability study and Thermal cycling study on development trial batches.
  • Preparation of Product Development Report.
  • Support for the technology transfer of manufacturing procedure from R&D to manufacturing plant with required documentation.
  • Application of QBD during product development with required documentation.
  • Compilation of analytical results and conclusion’s for stability trend.
  • Characterization of formulation & API for particle size, zeta potential, XRD, Polymorph, solubility, TEM, SEM, etc. at In-house and out sourced laboratories.
  • Support for the filter validation studies.
  • Evaluation of API and Excipients for various markets.
  • Preparation of In-process, finished product release and finished product stability specifications as per ICH guidelines.
  • RLD/ Innovator procurement and analysis III) Support with the innovative ideas for the development of new platform technologies. IV) Development of lyophilization cycle. V) Test license, Import license application and record maintenance. VI) Procurement of Raw material, Packaging material, Consumables and Eq


Preferred candidate profile



Perks and benefits


Job location Hyderabad



Role:Pharmaceutical & Biotechnology - Other

Salary: Not Disclosed by Recruiter

Industry:Pharmaceutical & Life Sciences

Department:Research & Development

Role Category:Pharmaceutical & Biotechnology

Employment Type:Full Time, Permanent

Education

PG:MS/M.Sc(Science) in Chemistry

Company Profile

Hetero

M/s. Hetero Drugs Ltd is one of the Largest Pharmaceutical Company in India.
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Contact Company:Hetero

Address:7-2-A2,,,Hetero Corporae,Industrial Estate,Sanath Nagar , Hyderabad, Telangana, India

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