Sr. GM - MSTG Orals

Job Title

Lead MSTG Orals

Job Grade

G6

Function

MSTG

Sub-function

MSTG-Orals

Manager's Job Title

Senior Vice President

Skip Level Manager's Title

Function Head Title :

Senior Vice President

Location : Halol

No. of Direct Reports (if any)

Date Of Joining

Job Summary

Lead MSTG Orals

Areas of Responsibility

Details Of Responsibilities Assigned

• To coordinate with different departments i.e. Formulation Development (FDD), Analytical Development (ADD), Packaging Development (PDD), Production, Engineering, Quality Control, Quality Assurance, Supply Chain, Business Development, Project Management and any other department for the timely execution of the New projects
• To plan for the Trial, Scale up and Exhibit batches of the New Projects.
• To oversee manufacturing of trial / scale up / exhibit / characterization / process validation batches.
• To plan and monitor the Pre- validation / characterization batches.
• To review / approve documentation like trial batch objective, trial batch BMR, protocols (for Trial, CH, PV any other) and respective reports, justification, regulatory query response, write up for any recommendation / data compilation, study protocol / report etc.
• To prepare the Justification / Investigation / Technical report for any failure / deviation / event observed during the execution of the Exhibit batches.
• To arrange for the readiness of the New Product Launch.
• To investigate and resolve the Trouble shooting projects in collaboration with Production and QA.
• To prepare technical justification / review the response for the regulatory query.

Key Skills

Deep Technical Knowledge

Process Engineering

Stakeholder Management

Regulatory Compliance

Cross-functional Collaboration

Risk Assessment

Travel Estimate

Yes, to multiple sites

Job Scope

Internal Interactions (within the organization)

FRD, ADD, PMO, Mfg.

External Interactions (outside the organization)

Vendors, CMOs

Geographical Scope

Global

Financial Accountability (cost / revenue with exclusive authority)

Job Requirements

Educational Qualification

M. Pharm

Specific Certification

Skills

Experience

20+ Years

Skills Required

Risk Assessment, Regulatory Compliance, Process Engineering, Stakeholder Management