Scientist/sr. scientist - Formulations (DPD)

Curateq Biologics

8 - 11 years

10 - 17 Lacs

hyderabad

Posted:1 hour ago| Platform:

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Skills Required

cmc formulation development monoclonal antibodies protein

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities

Senior Scientist - Formulations (DPD)

Formulation development and fill finish process development for Injectable drug products.
Risk assessment, process characterization of DP manufacturing process.
Technology transfer of drug product manufacturing process from R&D to manufacturing site.
Execution of lab activities in development of non-infringing/novel formulations/high concentration formulation for liquid and lyophilized formulation.
Execution of lab activities in selection and recommendation of container closure system (primary packaging material) and filters for drug products.
Preparation of study protocols and reports and review drug product specific BPR, MFR.
Ensure compliance to quality procedures of research and development organization and author SOPs specific to process lab or drug product.
Support in drafting relevant CMC sections for different regulatory submissions.

Experience

M.Pharm., M.Tech or M.Sc with at least 10 years of experience in drug product development preferably Injectable. Experience with protein/mAb drug products will be plus.

Preferred candidate profile

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