Job Description:Position: Assistant Scientist / Scientist - CMC (Formulation) - InjectablesReporting to: Lead scientist/Associate Director -CMCLocation: Hyderabad, IndiaEducation/Qualifications: M. Pharm/Ph.D from premier institute.Experience: At least 7-9 years of industrial research experience, in the field of formulation development for differentiated products/ 505 B2 products/generics (Injectable dosage form) for global markets including Scale up and Tech transfer experience.Job Description:Carry out Formulation and process development activities on differentiated formulations and innovative technologies to achieve Product development with adherence to timelines.Carry out & support Process development for R&D and pilot scale to achieve Product development with adherence to timelines.Carry out & support Late-stage development of differentiated products for LBOE India & Global LCM and support their regulatory filing. to achieve Derive a stable formulation and scaleup to commercial. Establishing design space and derive the CQA & CPPs to achieve a reproducible product and process.Scale up activities by providing the scale up factor/suggesting the appropriate methodology, Identifying the optimum process parameters for commercial batches based on trends observed in first few commercial batches to achieve.Coordinate with CROs and CMOs for the external development of Projects and for IMP supplies to achieve Timely completion of projects in line with the requirements.Carry out Subject Matter Expertise in defining and execution of complete strategy for product development for complex injectable dosage type, identifying critical CQA for structural & physiochemical parameters to achieve Product development with adherence to timelines.Carry out & Support Trouble shooting in CMC related activities and adequate investigation, identification and rectification of problem to achieve Product development in compliance to quality systems.Support Delivery of Project defined Deliverables including plans, meeting budgets and status reports to achieve Provide regular updates and ensure that the project meets budget and defined timelines.Carryout & Support Writing and Review of protocols, reports, validation plans and development report to achieve Product development in compliance to quality systems.Carryout & Support Developing, maintaining, and upgrading FHPDC facility to achieve Support the facility team to maintain and run at FHPDC site.Support Stage gate clearance for product development, with special attention to regulatory and intellectual requirements to achieve Product development.Carryout/ Process optimization with special focus on QbD aspects of drug product development to achieve Product development.Competencies and ExpertiseSound knowledge of regulatory and intellectual property sciencesExpertise in handling Injectables, such as Peptide based Injections.Expertise in tech transfer and execution of drug product (Injectables) manufacturing at external partner siteGood level of concept-based product development skillsScientific skill in early stage & Late-Stage DevelopmentLiterature search new product ideation skillFamiliar on GxPFluent in English and excellent communication skillsProactive and team orientedLocation: Ferring India FHPDC R&D
