Assistant Scientist / Scientist - CMC (Formulation)
Location
Secunderabad | India
Job description
- 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 :
- 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.
Competencies and Expertise
- 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
Job tags
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