Company Overview

Role Purpose

Academic Stream

Work experience (in months)

Job Responsibility and key Decisions

Formulation Development

Lead the development of liquid, lyophilized, or other novel formulations to ensure target product quality, stability, and delivery performance.

Guide preformulation studies e.g., solubility, stability, compatibility to support molecule screening and selection.

Evaluate excipients, containersclosure systems, and formulation strategies for biologics, small molecules, or biosimilars.

Drug Product Process Development

Develop and optimize drug product unit operations aseptic filling, filtration, lyophilization, mixing, vialing, etc.

Scaleup drug product processes from labscale to pilot or manufacturing scale, ensuring manufacturability and compliance.

Support tech transfer to manufacturing sites or CMOs, including drafting protocols, batch records, and process instructions.

Characterization Stability

Define and oversee stability studies, forced degradation studies, and stress testing in alignment with ICH guidelines.

Manage extractables and leachables studies InhouseCRO

Interpret critical quality attributes CQAs and link them to critical process parameters CPPs for riskbased control strategy development.

Utilize analytical data to guide formulationprocess decisionmaking.

Documentation Compliance

Author and review technical reports, formulation development summaries, CMC sections of regulatory submissions INDIMPDBLANDA.

Ensure compliance with GxP, QbD, ICH, USPEP, and internal quality systems.

Support regulatory inspections, audits, and crossfunctional review processes.

Team Leadership Project Management

Manage and mentor a multidisciplinary team of formulation scientists and process engineers.

Allocate resources, assign responsibilities, and ensure ontime delivery of milestones across multiple projects.

Collaborate closely with crossfunctional groups Analytical Sciences, Manufacturing, QA, Regulatory Affairs, and Packaging Development.

Selection of formulation strategies, excipient combinations, and containerclosure systems.

Definition of process design spaces, CPPs, and CQAs for drug product manufacturing.

Recommendations for technology transfer, batch sizes, and site readiness.

Interpretation of stability data and impact on shelflife or regulatory strategy.

Prioritization of development projects and allocation of team resources.

Vendor or CMO selection input based on technical and operational fit.