- Carry out Formulation and development activities on differentiated formulations and innovative technologies to achieve Product development with adherence to timelines.
- Carry out & support Selection of appropriate development approaches and establish proof of concept meeting desired target product profile 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.
- Support New product ideation process to build product pipeline with meaningful differentiation to achieve Conceptualization of new product ideas and brainstorming.
- Subject Matter Expertise in defining and execution of complete strategy for product development for Oral 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.
- Carry out /Support Scientific literature search (Articles/patents/publications/books) and compilation of experimental data, which will facilitate decision making to achieve Product development.
- 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 Formulation optimization with special focus on biopharmaceutical properties of drug substance and drug products to achieve Product development.
- Sound knowledge of regulatory and intellectual property sciences
- Expertise in tech transfer and execution of drug product (Oral) manufacturing at external partner site
- Good level of concept-based product development skills
- Scientific skill in early stage & Late-Stage Development
- Literature search new product ideation skill
- Familiar on GxP
- Fluent in English and excellent communication skills
- Proactive and team oriented
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Assistant Scientist - india, India - Ferring Pharmaceuticals
2 weeks ago
Description
Job Description:
Position : Assistant Scientist / Scientist - CMC (Formulation)
Reporting to : Lead scientist/Associate Director -CMC
Location : Hyderabad, India
Education/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 (oral dosage form) for global markets including Scale up and Tech transfer experience.
Job Description :
Competencies and Expertise
Location:
Ferring India FHPDC R&D
