Chemical Laboratory Manager

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. 

• Direct and organize the operations Chemical Laboratory. This includes the participation in the development of Jayuya policy systems and standardoperatingprocedures for specifications, and directions for testing in the following areas: RawMaterials,In- Process Materials, Finished Products, Stability Program, Method Transfer. Responsibleforthe compliance to all government regulations, company policiesandproceduresrelatedtothe assigned areas. Responsibleforthevalidation activities relatedtothelaboratory, including change control and Quality Monitoring. The primary result of this position is to assure all activities carriedoutin the laboratories are properly performed in accordance with FDA regulations and USP standard and that the services are carriedoutin an expeditious and cost-effective manner maintaining a high degree of compliance meeting the overall business priorities and schedules.
• Coordinates all Chemical Laboratory activities with Manufacturing and Supply Chain group.
• Lead the activities of the Laboratory Operations. Responsibleforthe supervision and training of exempt and non-exempt personnel in the group.
• Responsibleforthevalidation program at the chemical laboratory including but not limited to equipment, process, test methods, and software among others.
• Establishes and implement laboratory standardoperatingprocedures and policies according to global policies and regulations.
• Run the method transfer program for the laboratory, where applicable. Active participation in process validation and revalidation programs. Responsibleforthe analysis of validation samples.
• Identify and implement with the help of R & D (if needed) the improvements in laboratory testing methods and automation to upgrade the laboratory efficiency, consistent with lowest possible cost objectives of business.
• Participate in the approval, revision and implementation of rawmaterials,in process, finished product, and other documents.
• Ensures all changes needed are managed through the applicable change control system.
• Accountable for the Product Stability Program.
• Assure the staff, supervisors, and employees follow all federal, state, and company requirements, such as OSHA, EPA, FDA.
• Performs weekly, monthly and annual reports as required by Plant Senior Managements, policiesandprocedures.
• Conducts and approved laboratory investigations.
• Conducts trend analysis including data of Annual Product Reviews.
• Ensures that all analyst assigned to perform testing have been adequately trained in the test and the methodology according to Good Laboratory Practices delineated in cGMP’s, company standards and regulatory requirements for achieved accurate laboratory testing results (FDA Guideline for laboratory operation).
• Audit in a routine basis the analyst’s performance and accuracy of all and documentation performed in the laboratory to ensure the effectiveness of the training performed.
• Develop and ownsthe departmental budget and capital budget. Ensure to keep technologies, software, equipment updated and submit capital requests as needed.
• Ensure all services contracts applicable tothelaboratory are maintained and updated.

• Bachelor’sdegree in chemistry or science related field. Chemistry license preferred.
• Minimum8years’experience in quality systems
• Minimum 3 years’ management/supervisory experience in a laboratory environment.
• Knowledge in ICP-MS, HPLC, UPLC, GC, Atomic Absorption, and wet chemical lab procedures.
• Root Cause Analysis Training and Experience
• Excellentanalyticalandproblem-solvingskills(groupfacilitation,conflictresolution)andtheabilitytohandlemultipleprojectssimultaneouslywhileworkinginafast-pacedenvironment.
• Strong PC and Software skills (MS Office, Statistical software).
• Ability to train,empower, coach and work withothers.
• Strong presentation skills
• Provenexperience in changemanagement and leading change
• Customerfocus including theabilityto clearly communicate both oral and written.
• Proven values of honesty and integrity, respect for others, partnership, collaboration, accountability, and performance.
• Excellentanalyticalandproblem-solvingskills(groupfacilitation,conflictresolution)andtheabilitytohandlemultipleprojectssimultaneouslywhileworkinginafast-pacedenvironment

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.

EEO is the Law 
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Reasonable Accommodations

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