Manager ADL

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.

Your Role at Baxter

This is where your work saves lives

The research we do and the products we develop improve outcomes for patients around the world. As a Manager - ADL at Baxter, your work contributes directly to making a significant impact on others. It's challenging work—and you're not on your own. Our teams collaborate cross-functionally and lead by influence. Whether guiding a team through a project or managing direct reports, our research and development team is responsible for influencing others to achieve results.

Our colleagues within our R&D organization desire to work on products that make a meaningful difference in others' lives. We are motivated by the power of teamwork and are natural leaders who are skilled at influencing others.

What you'll be doing !

• Planning and monitoring of Validation, Postproduction and Query related studies as per schedule and work allocation to analyst.
• To provide the technical support/mentorship to the QC lab during OOS/OOT investigations
• To ensure in depth understanding of the project and to provide all Regulatory submission documents as per committed timelines.
• To guide the team in resolving the technical challenge (if any) observed during the execution of analytical activity and to keep the department head advised in case of any deviation from the committed timeline
• To keep track of the activities assigned to the team and ensure timely completion as per stipulated timelines
• TEnsure availability of required resources well in advance for smooth functioning of analytical activities of the team.
• To resolve any analytical issue observed during the study and to ensure proper investigation of non-conformance of results.
• To Provide response to the queries received from various regulatory agencies in scientific/logical manner within the stipulated timeline.
• Review and approval of Standard Operating Procedures.
• To check the pre-requirement for Installation of Instruments and to ensure installation and qualification of Laboratory instruments in timely manner as per organization requirement.
• Track regulatory commitments and take appropriate action from analytical GMP function
• Collaborate with cross functional team members i.e., project management, Regulatory Affairs, Formulation development, manufacturing, and quality control for smooth execution of projects from analytical perspective
• To review the status of daily work of the team and report to the Manager on daily basis.
• To review and to implement safety requirements as per policy.
• To ensure compliance/mitigation of HAZID, E&C, Data integrity, training & cGLP followed in the team
• Responsible for timely closure of LIR, NCR, CCN, CAPA and to ensure the implementation of appropriate Corrective and Preventive action wherever required
• Ensure compliance to Pharmacopoeia update for the assigned projects in timely.
• Adherence to the Baxter’s Code of conduct principles, SOP compliance pertaining to Analytical, quality and R&D site
• To understand and ensure cGLP within ADL GMP function
• To provide support to the manufacturing plant during Quality inspections performed by the regulatory agencies

What you'll bring !

• 14+ yrs of experience in Method development with prior exp in injectables is preferred
• Experience handling investigation, Trouble shooting from plant investigation standpoint
• Masters in Pharma or equivlent stream is mandatory
• Experience handling and nurturing the Mid-Sized team
• Person should have good communication and collaborator and required leadership skills.

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

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