Manager/Sr Manager - R&D (Pneumococcal conjugate Formulation)

Role & responsibilities

position is to develop formulation for polysaccharides conjugated with carrier protein. This role is to ensure formulation process development to operates in full compliance with sound scientific practice GMP and regulatory expectations especially for pneumococcal polysaccharide conjugate vaccine (PCV

Oversee the development and formulation of PCVs, ensuring adherence to regulatory standards and scientific guidelines.

Ensure regulatory compliance regarding vaccine safety, efficacy, and quality control.

Develop and implement market access strategies for DP including pricing, distribution, and promotional activities.

Build relationships with different stakeholders (R&D, clinical affairs, marketing, and supply chain teams) to align product development.

Design, Establish and Execute all activities in the areas of formulation development.

Responsible to work on the process development activities for formulation process.

Designing process development studies using DOEs, analyzing and concluding results with statistical inference Execute the design of experiments(DoE) using scale-up and scale down models and the interpretation of these results with respect to the cGMP manufacturing process.

Led a team of scientists and research associates for planning and execution of different formulations.

Openness to new ideas and approaches in vaccine formulation and delivery.

Scale down model qualification by equivalency testing between the scales.

Strong theoretical knowledge in Process Characterization and Risk Assessment following Quality By Design (QBD) principles and ICH guidelines.

Gap assessment of functional SOPs; management of equipment and lab.

Responsible for maintaining and accountable for, DS manufacturing and inventory maintenance specific to the allocated projects.

Online data management for the projects and interpretation of the experimental results, maintenance of projects batch data.

Execution and implementation of new process technologies using scale-up and scale-down models.

Preparation and review of SOPs/protocols for product tech transfer, operational equipment, batch processing records, development reports, user requirement specification (URS).

Handling quality incidents, change controls, Corrective and Preventive Action (CAPA).

Ability to identity and solve processing issues for process improvisation.

Preferred candidate profile

Perks and benefits