Ferring Pharma Assistant Scientist Job Opening – Apply Online
Assistant Scientist / Scientist – CMC (Formulation) – Injectables
Location: Hyderabad, India
Time type: Full time
Posted on: Posted Today
Job Requisition ID: R0028410
Job Description:
Position: Assistant Scientist / Scientist – CMC (Formulation) – Injectables
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 (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 Expertise
- Sound knowledge of regulatory and intellectual property sciences
- Expertise in handling Injectables, such as Peptide based Injections.
- Expertise in tech transfer and execution of drug product (Injectables) 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: Ferring India FHPDC R&D
