Sr.GM & Head of R & D

Job Description

Title: Sr.GM & Head of R & D

Company Name: Advanced Chemical Industries Limited (ACI)

Vacancy: Not specific

Job Location: Narayanganj

Employment Status: Full-time

Educational Requirements:
∎ PhD in Pharmaceutics, Master of Pharmacy (M.Pharm) in Pharmaceutics
∎ Skills Required: (IR and ER dosage forms including MUPS, Tablets

Experience Requirements:
∎ At least 15 year(s)
∎ The applicants should have experience in the following area(s): Pharmaceuticals Research and Development
∎ The applicants should have experience in the following business area(s): Pharmaceuticals

Job Responsibilities:
∎ Formulation & development of stable, pharmaceutically and bioequivalent new product based on QBD Approach. Technology transfer of products from R&D lab to site (Pilot scale).
∎ To manage a team of scientists (internal and contractors) focused on API,pre-formulation, formulation, manufacturing process development, technology transfer, established product support, analytical sciences.
∎ To lead prototype development, bioequivalence study, scale up activities, Technology Transfers, based on QBD at in-house pilot plant which includes data interpretation and establishing in vitro and in vivo correlation and critical process parameters along with control strategies
∎ To perform prototype development, technical evaluation and suitability of site transfer for Jubilant products and In-licensing projects.
∎ Work with relevant cross-functional stakeholders (e.g., Commercial Operations, Quality Control, Quality Assurance, Supply Chain Management, Procurement etc.) on scale-up and technology transfer of processes from R&D to commercial functions.
∎ To co-ordinate for preparation of Technology Transfer Documents & successful Technology Transfer.
∎ Life Cycle management of commercial products.
∎ Product screening, feasibility evaluation and technical assessment and budget preparation.
∎ Development of alternate vendors for API's and Excipients. Cost saving idea generation for process/ formulation and implementation at site. Reformulation and troubleshooting of commercial products.
∎ To provide technical support to manufacturing site for OOS/ OOT investigations & to Drug regulatory affair for regulatory queries.
∎ Regulatory support for deficiency response received from regulatory agencies Arrange CFT's meetings for clearance of phase gate and stage gate of development projects.
∎ Co-ordinate with different stakeholders like SCM, IP, DRA, QA, QC, Production, ARD & F&D for smooth operation.
∎ Involved in day-to-day analytical planning for effective resource utilization with an aim to maximize the efficiency.
∎ Life Cycle Management: Successfully implemented alternate source of API's and excipients in commercial products for cost saving/de-risking purpose.
∎ Process improvement/Reformulation done and change implemented at manufacturing site for 3 products. Developed Critical DR Tab/ Pellets/MUPS/POS (Powder for Oral solution), Matrix Formulations/immediate release formulation/Processes for key molecules.
∎ To prepare, track and communicate the project timeline and progress with internal & external customers.
∎ Preparation of R&D yearly budget.

Additional Requirements:
∎ Age 40 to 50 years
∎ Both males and females are allowed to apply
∎ Candidates must have at least 15 years of experience in Pharmaceutical Formulation Development, Process Development & Validation, Technology Transfer, Reformulation & Life Cycle Management.

Salary: Negotiable

Job Source: Bdjobs.com Online Job Posting.

Application Deadline: 31 Mar 2023

Company Information:
∎ 23 Mar 2023
∎ Advanced Chemical Industries Limited (ACI)
∎ Address : ACI Centre, 245 Tejgaon Industrial Area, Dhaka-1208.
∎ Web : www.aci-bd.com
∎ Business : Pharmaceuticals; Agribusiness; Consumer Brands.

Category: Medical/Pharma

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