About the role
ZTMP – REQUEST FORMAT
Name : Isha Naik
BU : GCM
Place : ZLL-SEZ Oncology Injectable, SEZ, Matoda, Ahmedabad.
Basic Details:
Position : 60047558
Designation : Deputy Manager
Reports to : GCM Head
Department : GCM
Location : ZLL-SEZ Oncology Injectable (Alidac)
No of Posts : 1
Role : Deputy Manager
Neev Level : 1
Details : Replacement
Position code : 60047558
Position Name : GCM BD & Out licensing - PM
Key Job Description: (Not more than 5 points in 6 lines)
Job Purpose
Job Details
Role
Project Management - Global Contract Manufacturing India CMO
Location
Mfg. site, Ahmedabad
Experience
5-10 years
Summary
Project mgt. Role at GCM (Global Contracting Manufacturing) is an integrated department which India CMO, CDMO for OSD, Injectables, complex injectables projects for regulated markets (India, EU).
Strong Analytical skills for Project mgt. skills of awarded projects for development to Understanding of SAP, India product LL, P2P , launch coordination, On site coordination from Daman, Goa, Ahmedabad sites(Open to travel)
Accountable for proactively managing successful execution of all assigned client projects where major focus would be to WBS, Project coordination, stage gate project mgt., Launch, commercial product Project mgt, with site teams (Mfg., QC, QA, CQA, supply chain, clients CFT. Legal team coordination for CDA, LL, P2P, Mfg. agreements, Tech transfer etc.
Key Stakeholders
· Client: Plant team, QA, Supply chain, client leads
· Zydus: Demand & Supply planning, Production, QC, RnD team & Regulatory Affairs.
Performance Indicators
· Development of WBS, Project charter, Technical evaluation
· OTIF(One time and in full) Launches of India CMO projects (85% ) and 90% of commercial products. Technical evaluation of Products, RFQ, RFQ Alliance Management / Project Mgt of CDMO and CMO Projects with regular interaction with clients.
· Costing , PO
· Business case & Scenario development for potential business deals
Responsibilities
· Point of contact from Client side with internal stake holders on deliverables & maintain and update the Client on project milestones/ progress. Participate in COE, Launch readiness meeting and get updated on the project status.
· To lead the Project Management calls with Client along with internal stake holders (Point of contact).
· To project mange with CFT the Technical documentation review, Launch update, facilitate regulatory audits, face to face meeting /weekly telecom, minutes etc. on behalf of client. Regular follow up/update on Annual forecasts, pending order, maintaining MIS etc.
· To develop scenarios/BC for Potential Out license deals, WBS, undertake market research on potential molecules , work with legal team on CDA, OL agreement, project plans and commercial delivery update .
Competencies
· Minimum 8-10 Years of experience with at least 5-9 years in Project Management and preferably should have handled client serving projects for regulated markets.
· Must have handled India, Regulated Formulation plants/Markets projects for OSD, Injectables dosage forms.
· Basic knowledge of Legal agreements (commercial & supply, quality & technical, MSA, CDA) and working as per contractual obligations.
· Caliber of undergoing competitive intelligence and market research would be preferred.
· Managing cross functional team & understands project management process & milestones for US, Europe development and site transfer projects.
· Comprehends the importance of process and should be excellent at written & verbal communication.
· Must have sound knowledge MS office (Word, Excel & PPT).
· Possess the good presentation skills, data representation, IMS evaluation, SAP.
· Go-getter. Proactive & is ready to accept the challenges.
Qualification : B. Pharm /M.pharm with MBA or PMP
Years of Experience : 5 to10 Years