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\xe2\x80\x94where your purpose accelerates our mission.

• Play a Lead role in the analytical development function with specific focus on analytical method validation, method transfer, documentation for method transfer, post production studies for dossier submission, investigational studies associated with GMP samples, query response for Generic, differentiated and complex parenteral products

• The job requires extensive collaboration with internal (PM, RA, PQ, F&D, M&Q etc) and external stakeholders including CMOs within and out of India
• To develop a scientific talent pool with quality mindset and Data Integrity principles so that function is able to manage GMP work within laboratory and ready for audit all time.
• The high level objective is to achieve the organization goal by validating and transferring methods for complex, differentiated, 505b (2) and generic ANDAs as per the committed timelines
• Oversee the laboratory operations essential for above work-flow viz., store, procurement of impurities, columns, working with other CROs for capabilities not available in-house
• Establish processes within GMP function so that all activities of laboratory, people and quality management systems are smooth

Essential Duties and Responsibilities:

• To lead a team and participate in analytical strategies for method validation, transfer and other GMP work related to complex, differentiated, 505b (2) and generic ANDAs, within areas of expertise to address specific technical requirements of a project/program

• Manage resource planning (laboratory as well manpower) and ensure the availability as per requirements in a timely manner.
• Prioritization of projects based on allotted annual budget and resources

• Evaluate results relative to product requirements, definitions and/or program goals.
• Build effective relationship with CFT/CMOs/CROs and other customers
• Play a lead role in resolution of the challenges faced during validation and method transfer of new products from R&D to different Manufacturing sites
• Responsible for identification and procurement of required CAPEX (instrument/equipment) in analytical development department for product development
• Provide solutions and or suggest on method validation/transfer/investigation/PP studies related challenges
• Review plan, coordinate and manage laboratory activities in coordination with team members
• Review project budget and schedule, proposals by collaborating with other stake holders
• Adherence to the Baxter\xe2\x80\x99s Code of conduct principles, SOP compliance pertaining to development, quality, and R&D site
• Play a lead role in support to manufacturing site during audit
• Responsible for all remediation related activities
• Ensure the PDLM processes and implement in development programme as per GQP requirements
• To support the regulatory for filing and query responses
• To ensure timely closure of quality elements (CCN/CAPA/NCR/SNCR)
• Maintain focus on meeting both external and internal customer expectations
• Read and understand all trainings/SOP\xe2\x80\x99s applicable to R&D and ensure to follow the processes/Practices as per defined SOP\xe2\x80\x99s by team members

• Support management in concluding Quality inspections, GMP deficiencies response
• Must comply with safety policies of the company and site
• Provides direct coaching, mentoring and development to each member of the team, both in execution of their responsibilities and in their own personal development
• To ensure compliance/mitigation of HAZARD, E&C, Data integrity, training & GLP in ADL department

Qualifications: Educational Qualification: Master\xe2\x80\x99s in Science (Organic Chemistry)/Pharmaceutical analysis

• Master\xe2\x80\x99s degree with 15-20 years pharmaceutical experience of this 8-10 years in managing a GMP laboratory with experience in method validation, transfer and relevant documentation
• Excellent leadership skills
• Effective communication and negotiation skills across different organizational level, matrices, and boundaries
• Expert in understanding of pharmaceuticals analytical principles
• Strong project management ability (e.q. successful delivery of projects on time and in budget) applied within a multi-disciplinary R&D environment
• Analytical, problem solving and decision-making competencies
• Ability to work effectively in international collaborations and multicultural environments
• Well organized and structured, able to prioritize and multi-task
• Comfortable taking autonomous actions and decisions (up to level of job responsibility)
• Solid understanding and basic knowledge of CFT departments working principles
• Understanding of cGMP principles and their implementation in ADL labs
• Experience in authoring/reviewing regulatory submissions. Establish effective writing and review system in the GMP function
• Ability to demonstrate autonomy in representing functional area
• Mathematical modelling of data
• Liaison & Coordination - Experience in working with CMO and managing external projects across globe
• Demonstrates critical thinking skills in problem solving and decision making
• Effectively presents information and ideas formally and informally, verbally and in writing to others in a manner that facilitates understanding
• Has good interpersonal skills and works collaboratively in an effective manner to achieve objectives
• Shows commitment and dedication and strives to be ahead of schedule

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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