Title: Assistant Manager, R & D Formulation
Company Name: Advanced Chemical Industries PLC (ACI)
Vacancy: --
Age: 28 to 35 years
Job Location: Narayanganj (Sonargaon)
Salary: Negotiable
Experience:
Must have working experience in regulatory market
Supervise team in ANDA development and life cycle management to ensure successful on-time project delivery.
Work collaboratively with relevant cross functional teams on ANDA development and to resolve ingredient and product technical issues.
Develop robust formulations and processes for immediate release and modified release tablet and capsule dosage forms.
Evaluate patents review summary submitted by IPR and suggest and/or develop non-infringement strategies.
Scale-up and optimization of manufacturing process; execution of pre-exhibit and exhibit batches; scale up and technology transfer from R&D to TT team to meet timelines.
Work with TT team to troubleshoot technical, formulation and processing issues during pilot plantruns.
Plan and contribute to project-related scientific/technical activities (e.g. interpret results, critical assessment of data, draw relevant conclusions, and write reports).
Author technical documents including Product Development Report, Quality Overall Summary and other relevant documents for regulatory filing purpose.
Interaction with API manufacturers, CROs and CMOs as needed.
Work proactively with other cross-functional groups to execute change controls associated with Manufacturing and Packaging master records, SOPs and protocols.
Coordinate with RA for filing ANDAs and addressing deficiencies; provide relevant documents to Regulatory Affairs in a timely manner for ANDA filings and Supplements filing.
Writing and approval of technical/scientific reports.
Share current knowledge & R&D data to cross functional department as needed.
Review of batch records, process characterization reports, validation reports and investigation reports as needed.
Create and review SOPs, as well as review appropriate documentation and test results for accuracy and completeness and compliance with SOPs/GMP requirement.
Maintenance of R&D laboratory to the highest required Quality Standards in line with company Quality Management Systems.
Maintenance of current knowledge via technical and scientific literature, where appropriate source and implement new technologies to improve R&D capabilities, address quality, regulatory and labeling issues for products.
Support and manage formulation-related corrective action plans.
| University | Percentage (%) |
|---|---|
| University of Asia Pacific | 15.09% |
| State University of Bangladesh | 13.21% |
| University of Development Alternative | 7.55% |
| Jagannath University | 6.60% |
| North South University | 6.60% |
| National University | 5.66% |
| Jahangirnagar University | 5.66% |
| Daffodil International University (DIU) | 4.72% |
| Independent University, Bangladesh | 4.72% |
| Rajshahi University | 1.89% |
| Age Range | Percentage (%) |
|---|---|
| 20-30 | 64.15% |
| 31-35 | 20.75% |
| 36-40 | 10.38% |
| 40+ | 4.72% |
| Salary Range | Percentage (%) |
|---|---|
| 0-20K | 8.49% |
| 20K-30K | 28.30% |
| 30K-40K | 26.42% |
| 40K-50K | 6.60% |
| 50K+ | 30.19% |
| Experience Range | Percentage (%) |
|---|---|
| 0 years (Freshers) | 34.91% |
| 0.1 - 1 years | 14.15% |
| 1.1 - 3 years | 13.21% |
| 3.1 - 5 years | 8.49% |
| 5+ years | 29.25% |