Formulator Assistant Officer
3 weeks ago
Purpose:
The Pharmaceutical R&D department develops new dosage forms and takes care of process development and scale-up activities. The Formulator Assistant Officer position will be responsible for pharmaceutical product development and associated activities in R&D. He will handle and monitor the formulation development activities of oral solid dosage form (OSD), sterile injectable and Biosimilars. He is also responsible for process optimization, scale-up and tech transfer of new products, supports to Regulatory department for new products dossier submission to various markets. He will actively involved in the validation and qualification of the facility and documentations, and other tasks assigned.
**Key responsibilities & Accountability**:
***
Formulation development of oral solid dosage form (OSD), sterile injectable and Biosimilars.
Organizes and executes preformulation studies.
Conducts small to pilot scale batch trials with approach.
Transfers formulations to commercial manufacture
Performs process development and optimization trials using “Quality by Design” approach.
Proactively assist in resolving formulation design issues identified during development, stability trials or process optimization.
Organizes and execute long-term stability studies.
Interprets and report results of work carried out in written and oral format.
Coordinates interdepartmental activities related to initiatives, meetings and events.
Evaluates external developments in the area of formulation development and make recommendations based on their applicability projects.
Communication of project status at internal meetings and through formulation reports.
Performs other duties as assigned consistently with goals.
**Qualifications**:
**- Education
Bachelor’s degree in Pharmacy
Master’s degree or equivalent in pharmaceutical science studies.
- Experience:
Has experience in STERILE and INJECTABLES are preferred.
- Training:
- Specialized Knowledge and Skills:
Possess in-depth knowledge about the basic and advanced concepts that are related to pharmaceutical development studies and process optimization.
Should be familiar with the regulatory requirements/guidelines and QbD (Quality by Design).
Excellent organizational and planning abilities.
Excellent communication and report writing skills.
Proactive, self-starter
**Key Competencies**:
***
Accountability Project Management Solving Problems Systems Thinking Technical Credibility
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