Job Description

This is where you save and sustain lives

At 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. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's 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.

Product design and lifecycle management

New product development

Product Remediation activities

Learning & Empowerment

Compliance

Infrastructural Enhancement

Integration activities

Regulatory query support

To lead and manage a team of experts and participate in planning and execution of drug product development.

Innovate and or assess formulation methodologies for simple and complex injectable formulation development.

Responsible for formulation development of new concepts from conceptualization, development, to exhibit batch trials as well as reworking on existing products if required.

Submission of documents about various licenses such as test license, manufacturing license, import licenses for API and drug product, and DCGI NOC.

Provide solutions and or suggestions on development-related issues.

Development of robust formulations and processes through optimization, scale-up, and validation work applying QbD principles including risk assessments and DoEs.

Review project budget and schedule, proposals by collaborating with other stakeholders.

Adherence to the Baxter's Code of conduct principles, SOP compliance about development, quality, and R&D site.

Coordination with the Production team for successful technology transfer of new formulations.

To review the technical documents e.g. Master Formula Record (MFR), Product Development Report (PDR), Product Development Lifecycle Management (PDLM) documents, Protocols & Reports.

Technology Transfer of acquired or developed formulation products in Baxter and/or in CMOS.

Coordination with various departments like analytical, regulatory, PM, CMO, vendors, purchase, and other cross-functional teams for smooth development and project execution.

To review and approve engineering batch & stability batch documents.

To support Process validation batches, if required.

To provide the required information for meetings with Contract Manufacturing Organizations (CMO), Contract Research Organizations (CRO) & contract Labs for on-time project delivery.

Must comply with safety policies of the company and site.

In the absence of reporting manager/HOD, the sub-department manager will ensure these roles and responsibilities.

Design and authorization of SOPs and ensure compliance as per SOP.

Adoption of GQP (Procedure integration with Baxter systems).

Adoption of TcU and PDLM.

Conduct training for team members when needed.

Reasonable Accommodations

Baxter 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 Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.

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