Microbiology Lead

Vantive: A New Company Built On Our Legacy

Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.

At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support.

*Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.

Microbiology Lead

GENERAL DESCRIPTION OF RESPONSIBILITIES:

• Responsible for the supervision of the Microbiology Department and a team of microbiologists. Coordinate daily operations for a team of microbiologists and laboratory assistants; ensure that objectives are set, monitored, and completed in proper priority.
• Responsibility for the routine microbiological monitoring of starting materials, finished products and environmental control systems and routine testing where required.  Responsible for the generation of documented procedures for Microbiological monitoring and responsible for compliance with documented procedures.
• Responsible for the identification and communication of adverse trends in routine microbiological monitoring
• Oversee sterilization testing and testing to support manufacturing and new product development.
• Consult on quality and microbiological issues, support problem solving and resolution, and provide quality management advice and counsel to customers for related laboratory testing needs.
• Your role will be to maintain regulatory compliance through established programs for lab testing, training, SOPs, and validation.
• Review and approve laboratory testing documentation.
• Facilitate, perform and review laboratory investigations.
• Assist in the creation and maintenance of laboratory SOPs and validation documents for GMP lab test procedures and systems.
• Assist in the writing of functional area status reports, regulatory documents, and process descriptions.
• Maintain environmental monitoring program.
• Maintain risk assessments required for parametric release.
• Management of lab equipment including, Qualifications, e.g. IQ/OQ, calibration and maintenance
• Participate in all GMP and operational training programs & complete associated Training Records
• Participate in internal and external audits (including regulatory)

EDUCATION REQUIREMENTS:

• 3rd level Degree in Microbiology or relevant experience in a similar field

EXPERIENCE REQUIREMENTS:

• 3rd level Degree in Microbiology or relevant experience in a similar field
• 5 years or more experience in a regulated pharmaceutical environment including people management experience.
• Experience of environmental monitoring and bacterial endotoxin testing
• Familiarity and understanding of FDA and EU pharmacopoeial requirements.
• Evidence of an acquired solid background of technical knowledge and experience, plus successful direction of significant projects
• Experience in supervising and motivating a team, project management experience and meeting deadlines.
• Excellent communication and interpersonal skills essential, proactive approach to work essential
• An ability to work independently as well as a member of a team in a dynamic, fast-paced environment essential

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.

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