Lead, Formulation Research & Development

Job Description

Title: Lead, Formulation Research & Development

Company Name: Renata PLC

Vacancy: --

Age: Na

Job Location: Dhaka

Salary: --

Experience:

• 12 to 15 years
• The applicants should have experience in the following business area(s): Pharmaceutical/Medicine Companies

• Master of Pharmacy (M.Pharm) in Pharmaceutical Technology
• PhD

• Master’s / PhD in Pharmaceutics, Pharmaceutical Technology or related discipline.

• 12 to 15 years
• The applicants should have experience in the following business area(s): Pharmaceutical/Medicine Companies

• Experience Requirements: 12–15 year(s) in formulation R&D, with minimum 5 years in a leadership role.

Skills & Competencies:

• Strong knowledge of solid oral dosage forms, injectables, and/or specialty formulations.

• Expertise in formulation science, process optimization, and troubleshooting.

• Sound understanding of global regulatory requirements.

Job Type: Pharmaceutical R&D

Major Responsibilities:

• Lead and oversee formulation development projects for new generic, branded generic, 505b (2), abridged application, and specialty pharmaceutical products.

• Define R&D strategies, aligning with company goals, market demands and regulatory pathways.

• Collaborate with cross-functional departments (QA, QC, Regulatory, Manufacturing, Supply Chain, Marketing).

• Guide pre-formulation, solubility enhancement, and excipient selection for complex 505b (2) and abridged application medicinal products

• Oversee pre-formulation, formulation design, and process optimization.

• Ensure robust product development applying QbD (Quality by Design) and DoE (Design of Experiments), including scale-up and technology transfer to manufacturing.

• Evaluate and implement advanced drug delivery systems and novel technologies.

• Review and approve development reports, dossiers, and technical documents.

• Ensure compliance with cGMP, ICH, USFDA, EMA, WHO, and other global regulatory guidelines.