Mgr, R&D - F&D at Baxter International

Ahmedabad, Gujarat, India

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

PharmaceuticalsIndustries

Requirements

Expertise in planning project technical feasibility experiments
Ability to handle end-to-end planning for resource availability on time
Proficiency in planning developmental trials, PDR studies/QbD additional studies for ANDA products
Skills in monitoring development trials
Experience in compilation of development data
Knowledge of ensuring development as per QbD approach
Capability to review technical documents (e.g., DMBD, PDR, protocols & reports)
Strong coordination skills with cross-functional teams (CFTs: ADL, IRA, Procurement, Quality) for on-time project execution
Experience in technology transfer of drug products (ANDA, 505(b)(2), complex injectables)
Familiarity with exhibit batch execution (ANDA, 505(b)(2), complex injectables)
Ability to support process validation and commercial batches (ANDA, 505(b)(2), complex injectables)
Expertise in reviewing technology transfer documents from CROs per regulatory requirements
Skills in supporting and coordinating with CMOs for successful technology transfer
Knowledge of fulfilling regulatory requirements by designing trials
Experience in training and knowledge enhancement of the team
Ability to design and authorize SOPs
Proficiency in execution and approval process of new equipment/instruments for projects and lab improvements
Capability to adopt GQP (procedures integration with Baxter systems)

Responsibilities

Planning of project technical feasibility experiments
End-to-end planning for resource availability on time
Planning of developmental trials, PDR studies/QbD additional 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, 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 equipment/instruments for projects in upcoming portfolio & continuous improvement of development lab
Adoption of GQP (procedures integration with Baxter systems)

Skills

QBD

ANDA

505(b)(2)

Technology Transfer

Process Validation

PDR Studies

DMBD

SOP Authoring

Regulatory Compliance

Exhibit Batches

CRO Coordination

CMO Coordination

Formulation Development

Injectables

Baxter International

Provides essential medical products and services

About Baxter International

Baxter International provides a wide range of medical products and services essential for healthcare. The company operates in several areas, including critical care, hospital care, nutritional care, renal care, and surgical care. Its products are used in various settings, from emergency rooms to home healthcare, helping to meet the needs of patients and healthcare professionals. Baxter develops, manufactures, and distributes medical devices, pharmaceuticals, and biotechnology products, generating revenue through sales to healthcare providers and institutions. A key aspect that sets Baxter apart from competitors is its recent acquisition of Hillrom, which enhances its ability to offer comprehensive healthcare solutions. The company's goal is to improve care outcomes and increase access to healthcare through continuous innovation and a focus on patient needs.

Deerfield, IllinoisHeadquarters

1931Year Founded

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Health Insurance

Dental Insurance

Life Insurance

Disability Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Parental Leave

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Commuter Benefits

Mental Health Support

Risks

Needle-free injection technology could disrupt Baxter's traditional injection-based therapies.

Shift to home healthcare may require Baxter to adapt its product offerings.

Growing digital health importance necessitates further investment from Baxter to stay competitive.

Differentiation

Baxter's acquisition of Hillrom enhances its comprehensive healthcare solutions portfolio.

Strong focus on patient-centric innovation sets Baxter apart in the healthcare industry.

Baxter's partnerships, like with Ayogo, leverage digital health for improved patient outcomes.

Upsides

Baxter's investment in Medically Home aligns with the growing home healthcare market.

Rising demand for personalized medicine offers Baxter opportunities for targeted therapies.

Expansion in telehealth supports Baxter's integrated healthcare solutions strategy.

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