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Manager, R&D - F&D

5.00 to 10.00 Years   Ahmedabad   04 May, 2022
Baxter India
Job LocationAhmedabad
EducationNot Mentioned
SalaryNot Disclosed
IndustryManufacturing
Functional AreaBio Tech / R&D / Scientist
EmploymentTypeFull-time

Job Description

    Manager, R&D - F&DApply Now Save JobThis is where you save and sustain livesAt Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. Youll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.Baxters products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.Together, 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.
    • Planning of Project technical feasibility experiment
    • End to end planning for Resource availability on timePlanning of developmental trials, PDR studies/QBD addiitonal studies for ANDA products
    • Planning of developmental trials, PDR studies/QBD addiitonal studies for ANDA products
    • Monitoring of development trials
    • Compilation of the development data
    • Ensuring development as per QBD approach
    • Review the technical documents e.g. DMBD, PDR and other protocols & reports.
    • Coordination with CFTs (ADL, IRA, Procurement, Quality) for on time project execution
    • Technology transfer of Drug product [ANDA, 505 (b)(2), Complex injectables]
    • Exhibit batch execution [ANDA, 505 (b)(2), Complex injectables]
    • Support for Process validation and commercial batches [ANDA, 505 (b)(2), Complex injectables]
    • Technology transfer documents review of Products developed by CRO as per regulatory requirement.
    • Support & coordination with CMOs for successful technology transfer
    • Fulfilling the regulatory requirements by designing the trials
    • Training & knowledge enhancement of the team
    • Design & Authorization of SOPs
    • Execution & approval process of New Equipments/Instruments for projects in upcoming portfolio & continuous improvement of Development Lab.
    • Adoption of GQP (Procedures integration with Baxter systems)
    Reasonable AccommodationsBaxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to hidden_email and let us know the nature of your request along with your contact information.Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice .067547Apply Now Save Job,

Keyskills :
approval processprocess validationcontinuous improvementregulatory requirementscropdrandafraudemailtrialsclinicsplanningportfoliomedical

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