Job Description
Title: Assistant Manager, R & D Formulation
Company Name: Advanced Chemical Industries Limited (ACI)
Vacancy: --
Age: 28 to 35 years
Location: Narayanganj (Sonargaon)
Minimum Salary: Negotiable
Experience:
∎ 6 to 10 years
∎ The applicants should have experience in the following business area(s):Pharmaceutical/Medicine Companies, Chemical Industries
Published: 22 Oct 2024
Education:
∎ Master of Pharmacy (M.Pharm) in Pharmacy, Master of Science (MSc) in Chemistry
Requirements:
Additional Requirements:
∎ Age 28 to 35 years
∎ Must have working experience in regulatory market
∎ Must have working experience in regulatory market
Responsibilities & Context:
∎ 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.
∎ 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.
Workplace:
∎ Work at office
Employment Status: Full Time
Job Location: Narayanganj (Sonargaon)
Apply URL::
Apply Procedure:
Company Information:
∎ Advanced Chemical Industries Limited (ACI)
∎ ACI Centre, 245 Tejgaon Industrial Area, Dhaka-1208.
∎ Pharmaceuticals; Agribusiness; Consumer Brands.
Address::
∎ ACI Centre, 245 Tejgaon Industrial Area, Dhaka-1208.
∎ Pharmaceuticals; Agribusiness; Consumer Brands.
Read Before Apply: Please apply only who are fulfilling all the requirements of this job
Application Deadline: 29 Oct 2024
Category: Others
