Title: Senior Manager, R & D Formulation
Company Name: Ziska Pharmaceuticals Ltd.
Vacancy: --
Age: Na
Job Location: Gazipur
Salary: Negotiable
Experience:
B. Pharm/M. Pharm in Pharmaceutical Technology, Pharmaceutics or a relevant pharmaceutical science discipline from a reputed public or private university.
Experience:
Minimum 12–15 years of relevant experience in pharmaceutical R&D, with substantial hands-on experience in formulation development.
Prior experience leading formulation development projects and supervising R&D professionals is essential.
Experience in developing and commercializing generic pharmaceutical products and managing scale-up and technology transfer activities.
Additional Requirements:
Strong technical expertise in pharmaceutical formulation development and optimization.
Sound understanding of pre-formulation, pharmaceutical excipients, dissolution, stability, and dosage-form design.
Knowledge of GMP, ICH guidelines, applicable pharmacopeial standards, and relevant regulatory requirements.
Strong analytical thinking, scientific judgment, troubleshooting, and problem-solving capabilities.
Job Location: Shofipur, Gazipur
Key Responsibilities
Lead the formulation R&D team in developing new pharmaceutical products, generic formulations, line extensions and improved formulations in alignment with business and product development strategies.
Plan, coordinate and supervise formulation development activities for various dosage forms, including tablets, capsules, oral liquids, suspensions, topical preparations and other pharmaceutical products.
Evaluate and select suitable APIs, excipients and packaging materials based on compatibility, functionality, quality, availability and cost-effectiveness.
Design and conduct pre-formulation studies, formulation trials, prototype development and optimization of formulation parameters to ensure product quality, efficacy and stability.
Lead laboratory-scale development, pilot-scale studies, process optimization, scale-up and technology transfer to Production for successful commercial manufacturing.
Coordinate stability studies with QC and Stability teams to establish product shelf life, storage conditions and compliance with applicable requirements.
Collaborate with Analytical R&D, QC, QA, Regulatory Affairs, Production and other relevant departments to ensure successful product development, registration and commercialization.
Review and interpret formulation data, analytical results, dissolution profiles, compatibility studies and stability data; provide technical solutions to formulation and manufacturing challenges.
Prepare, review and ensure the accuracy of formulation development reports, protocols, batch manufacturing records, specifications, SOPs and regulatory submission documents.
Ensure compliance with GMP requirements, applicable regulatory guidelines, data integrity principles and internal quality systems throughout formulation development activities.
Establish R&D project priorities, timelines, resource requirements and budgets; manage laboratory equipment, materials and consumables to ensure efficient project execution.
Lead, mentor and develop R&D personnel while identifying opportunities for product portfolio expansion, lifecycle management, reformulation, cost optimization and continuous improvement.
Salary: Negotiable, based on experience and qualifications
Contributory Provident Fund
Profit Sharing (WPPF)
Group Insurance
Other fringe benefits as per company policy