Company Overview
Role Purpose
Academic Stream
Work experience (in months)
Job Responsibility and key Decisions
Formulation Development
Design and optimize liquid, lyophilized, oral solid, parenteral, or novel formulations to ensure target product profile TPP, stability, and delivery performance.
Lead preformulation and compatibility studies including solubility, pH, excipient screening, and containerclosure system selection.
Oversee stress and degradation studies, forced degradation, and formulation robustness assessments.
Process Development Scaleup
Develop and scaleup drug product manufacturing processes e.g., PFS, Vial injectables, lyophilization, aseptic filling, terminal sterilization.
Define and optimize critical process parameters CPPs and link them to critical quality attributes CQAs using QbD principles.
Conduct labscale and pilotscale manufacturing, and support technology transfer to manufacturingCMO sites.
Regulatory Quality Documentation
Author and review key regulatory documents CMC sections of IND, IMPD, NDA, BLA, and technical reports.
Ensure GMPGLP compliance, and support internal and external audits and inspections.
Support specification setting and provide justification based on formulation and stability data.
Team Leadership Crossfunctional Collaboration
Supervise and mentor a team of formulation scientists and process engineers.
Plan and allocate resources across multiple programs in alignment with project priorities.
Collaborate with Analytical Sciences, Quality, Regulatory Affairs, Supply Chain, Manufacturing, and Clinical teams.
Innovation Continuous Improvement
Drive implementation of new technologies, platforms e.g., continuous manufacturing, QbD tools, and digital tools in formulation and process sciences.
Identify and evaluate opportunities to improve process efficiency, cost, and product performance.
Selection of formulation strategy, dosage form, excipients, and manufacturing approach.
Determination of scaleup parameters, process equipment, and control strategies.
Decisions related to process troubleshooting, deviation handling, and risk mitigation.
Input into batch sizing, tech transfer readiness, and site selection.
Final review and approval of technical protocols, batch records, and regulatory content
