RESEARCH & DEVELOPMENT MANAGER 606 views

Summary
Responsible for clinical trial tests, drug development, and modification. The Incumbent shall be responsible for all research and developmental activities for the organization.

Duties and Responsibilities
Designs and conducts pre-formulation, formulation, process, stability, and container closure system development studies for drug products according to local and international guidelines.
Responsible for the regulatory strategizing according to set standards and guidelines in relation to dossier submissions and cGMP.
Applying scientific fundamentals to solve formulation, stability, and manufacturing issues.
Identifies, plans, strategizes, formulates, implements and performs process improvements initiatives
Represents the formulation development function in cross-functional teams.
Prepares professional technical reports, presentations and Chemistry Manufacturing and Control (CMC) documents for regulatory submissions.
Develops and designs dissolution and suitable in-vitro discriminative performance test methods and validation.
Develops cGMP Manufacturing processes, process optimization, process qualification and process validation within the R n D department.
Responsible for sourcing of active and non-pharmaceutical excipients
Evaluates API drug master files.
Conducts batch scale-up, post-approval formulation and manufacturing process.

Educational Qualifications and Experience
First Degree in Pharmacy or equivalent
Atleast 5 years’ experience in the research and development and quality control.
Extensive knowledge in product development, modification and method development.
A fair appreciation of project management and leading a team of analysts and line staff members.