Specialist, R&D - PMT

Job Description

Specialist, R&D - PMTTogether, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.Join us at the intersection of saving and sustaining lives where your purpose accelerates our mission.About BaxterBaxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-centre dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter s employees worldwide are building upon the company s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care Job Summary

• To kick-off new projects by discussion with relevant stakeholders about major attributes of the project and align on its scope and target timelines. Project to be divided into various stage gates (Major Milestones) & the same to be plotted in MSP & Gantt Chart to be prepared. Thorough review of Tech transfer plan awarded to internal Baxter sites / CMOs.
• To follow up with sourcing team for ensuring timely availability of API, its technical package(O-DMF and other necessary documents), raw material ,packaging material & Lab consumables required for Tech Transfer, Method Transfer, PE & Stability batches at internal Baxter sites / CMOs.
• To follow up with Project Management Team (PM-1) for timely availability of licenses (NOC, F29, F11) at the CMO site (In case of Domestic Site).
• To follow up with sourcing team to ensure timely availability of RLD required to start new product development.
• To ensure smooth execution of project by tracking major activities of project on regular basis and work closely with cross functional team to expedite critical activities to meet project target timelines.
• To ensure timely GRN/QC Testing /Release of API/PPMs and successful method transfer at internal Baxter sites / CMO site for timely manufacturing of PE /Stability batches.
• Communication of firm PE & Stability batches dates to various stake holders at internal Baxter sites / CMO site for smoother operations.
• Intimation for stability charging with batch details to RA for start compilation of dossiers from Baxter Ahmedabad side.
• To have a fortnightly discussion in form of a formal meeting with team members for keeping a track on progress of project. Circulation of MOM within 24 hours of the meeting with points discussed, Accountability and Timelines.
• Facilitate to resolve critical issues and conflicts of project and escalate to higher management as and when required.
• Update the project plan and circulate gannt charts fortnightly to higher management for review/discussion.
• Foresee risks in projects & maintain risk register(by discussing with CFT) which also includes its probability & impact and have mitigation plans to avoid delay in project timelines.
• Prepare presentations required for senior management review which contain overall status of NPD projects pipeline and annual filing and approval target plan, budget consumed and other related info. as requested.
• Preparing dashboard of NPD projects overall summary for senior management review.
• To prepare presentation for monthly review meeting which captures current status, major open items, critical path and upcoming milestones of projects by discussion with all stakeholders.
• To update the global database on a monthly basis for any new filings or geo-expansions based on any addition or deletion.
• Preparing dashboard of Tech Transfer projects overall summary for senior management review
• To prepare Presentation (Tech Transfer) for monthly review meeting which captures current
• Product wise / Project wise health check up & health review for In house R&D Projects, Remediation Projects & Tech Transfer projects to be prepared / Checked / Get validated

EEO (Equal Employment Opportunity)Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.,

Keyskills :
environmental impact assessmentcontinuous improvement facilitationpatient carenew projectshealth checktech transfermethod transfer