Mgr, R&D F&D
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
This is whereyour work makes a difference.
At Baxter we believe every personregardless of who they are or where they are fromdeserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today tomorrow and beyond.
Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together our community is driven by a culture of courage trust and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations and we hold each other accountable for delivering exceptional results.
Here you will find more than just a jobyou will find purpose and pride.
- 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)
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.
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If because of a medical condition or disability you need a reasonable accommodation for any part of the application or interview process please click on the link here 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.
Required Experience:
Manager
Key Skills
- Laboratory Experience
- Vendor Management
- Design Controls
- C/C++
- FDA Regulations
- Intellectual Property Law
- ISO 13485
- Research Experience
- SolidWorks
- Research & Development
- Internet Of Things
- Product Development
About Company
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 ... View more
