Senior Research Associate - CMC Formulation

Position:

Reporting to:

Location:

Education/Qualifications:

Experience:

• 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 or oral solid 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 Expertise

• Sound knowledge of regulatory and intellectual property sciences
• Expertise in handling Injectables, such as Peptide based Injections or OSD.
• Expertise in tech transfer and execution of drug product 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
  

Location: