Sterility Assurance Laboratory Manager

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.

About Baxter

Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.

Job Summary

• Job Title – Laboratory Manager

• Location – Whitefield, Bangalore.

The Laboratory Manager Sterility Assurance will be responsible for the maintenance of a laboratory team which includes Container closure integrity, bacterial endotoxin and a moist heat autoclave. Activities will include responsible for all the microbiology related support from BRD in terms of testing, working with CRO and CTO for the topics related to Microbiology, Provide the Microbiology SME support to all the Sustaining and New Product Development projects for the R&D at Bangalore. This role will report to the Leadership for Sterility Assurance at BRD and will support Over all Research and Development related requirements for Kidney Care segment product portfolio. The candidate should have good experience Medical Devices and/or Pharmaceuticals.

This position is primarily responsible for the planning, designing, execution, documentation, data analysis and final report generation for Sterility Assurance studies for Devices, Drugs and Solutions. This position will also coordinate for all the sterility, sterile barrier and microbiology related testing needs from BRD.

The Lab Manager Role will be required to have knowledge in the following areas and will be required to provide support in following.

The role will have responsibility for the personnel and operations of the BRD Laboratories. Development and qualification of laboratory equipment and processes as well as the associated documentation. Test drug products and medical devices, including new product development, test method development & validation and investigations (including manufacturing support) in collaboration with external Laboratories for Microbiology, Contract Research, and testing Organizations. Manage a team of subject matter experts specializing in areas related to Container Closure Integrity, endotoxin and microbiology studies. Work with product development teams, product design owners, contract testing laboratories and manufacturing QA/QC laboratory personnel to complete assessments, required tasks. Be onsite for 5 days/week to support personnel working in the laboratory. Good understanding of principles of miicrobiology and the guidance available for device and solutions, sterilization science & the related guidance, container closure Integrity and related guidance. Good Understanding of design, development & technical understanding on principles for development and validation of microbial attributes related to device and solutions, understanding the risks and help design the controls. Good understanding of microbial investigations and failures in designs. Solid Leadership skills, team orientation and understanding of organizational cultural attributes. Sound Knowledge of statistics, data analysis, problem solving, troubleshooting knowledge of general aspects around the development of new products

Candidate working with a Device / Drug Company in Research & development, Sterility Assurance, Quality Assurance in leadership roles with exposure to people management and leading Laboratory Operations. Should have a sound knowledge of Global regulations best practices for Solution and Device related Microbiology testing and regulations. Exposure to product life cycle desirable.

Essential Duties and Responsibilities

The role will have responsibility for the personnel and operations of the Bangalore Sterility Assurance Laboratory management and the SME for microbiology. Development and qualification of laboratory equipment and processes as well as the associated documentation. Test drug products and medical devices, including new product development, test method development & validation and investigations (including manufacturing support). Manage a team of subject matter experts in microbiological, container closure Integrity and adventitious agents related studies and testing. Work with product development teams, product design owners, contract testing laboratories and manufacturing QA/QC laboratory personnel to complete required tasks. Be onsite for the work week to support personnel working in the laboratory and site requirements. Responsibilities include:Safe work practices of all personnel working in the Bangalore Sterility Assurance Laboratory.Managing laboratory resources to deliver on time test results.Constructing detailed, accurate schedules, interfacing with development, technical and manufacturing groups, leading teams through the planning and execution of work.Overall responsibilities for laboratory operations, including areas to be delegated to laboratory personnel, such as laboratory safety, stocking of necessary supplies, preparing necessary materials such as media, and maintenance of equipment.Assure laboratory and documentation is audit ready and team can effectively response to auditor inquiries.Assure appropriate investigations are conducted on laboratory failures and out of specifications.Supporting R&D project through input on laboratory testing needs or the use of existing data to support products.Devising new approaches to complex problems through adaptations and modifications of standard technical principles. Assure the use of appropriate standards in laboratory testing.Where necessary implement new procedures to support the testing of Baxter products.Assuring all work complies with Baxter’s Quality system and cGDP/cGMP practices.Providing regular updates to Sterility Assurance management. Contribute technical feasibility analysis of complex research and design concepts for sterility assurance and related controls for the products. Design and perform sterility assurance assessments and microbial qualification & validation studies in support of medical device, Solutions & pharmaceutical projects. Perform standard Microbial assignments for application, validity and conformance to specifications. Utilize analytical process tools to solve complex process problems (e.g., FMEA, Risk Analysis, Process Modeling, Design of Experiments). Lead small project teams as needed to accomplish project objectives. Study and recommend techniques to improve existing products/processes and process controls. Provide Microbiological expertise support for Kidney Care R&D projects and technical trouble shooting & to evaluate results relative to product requirements, definitions and/or program goals. Analysis and evaluation of study data and assist in the preparation of documentation using Good Documentation Practices (GDP). Employ appropriate techniques and methods to successfully conduct specific assignments within negotiated deadlines after receiving general instruction. Demonstrate working knowledge of basic technical theories and principles within area of expertise for routine tasks. Devise new approaches to complex problems through adaptations and modifications by use of standard technical principles. Maintain current knowledge of relevant Quality System Regulations and other regulatory requirements related to R&D (product development, design and safety) to ensure compliance in all research, data collection and reporting activities. Develop reports and presentations on technical plans and results. Display a solid understanding of theories/practices utilized by other disciplines outside primary area of expertise. Ability to Communicate and convince management on courses of action with minimal assistance using both written and verbal methods. Responsible for Representing the organization in Regulatory inspections as Subject Matter Expert for Microbiology.

Qualifications

Qualifications. The preferred candidate will have:

Strong Microbiology background and experience Demonstrated ability to lead a team of laboratory personnel, including ability to train and develop laboratory personnel. Experience managing multiple simultaneous projects and work activities. Knowledge of medical device and/or pharmaceutical industry Knowledge of GDP/GMP/GLP practices. Ability to convince management on courses of action with minimal assistance using both written and verbal methods.  Effectively operates in, and capable of facilitating, cross-functional teams.  Must be able to provide solutions that reflect understanding business objectives and cost implications.  Master’s degree in a scientific discipline (Microbiology/ Science/ Pharmacy/Engineering) with minimum 13 years or BS with minimum 15 years’ experience in Microbiology. A Ph D / Doctorate degree in Microbiology or related disciplines with 10 Plus years of New Product Development and Managing subject matter expertise in Microbiology Lab related operations. Preferred experience with Microbiology methods validation for Device and Solutions, Global sterilization regulations & TQM methods (e.g. "six sigma") Display a solid technical understanding of Microbiology principles and qualification practices & application of these principles on Development Projects. The position requires technical skills with Strong background in Microbiology and or Microbiological Operations for assessing critical changes & impact assessments, writing study rationale documents. Technical writing skills, remote support for Multiple projects, strong interpersonal skills and a quick adaptive mindset for the new technologies. Strong Data Analytical skills and exposure to new technologies for Sterilization in the Health Care Industry.

Skills

Experience in laboratory methods, including:Sterile barrier / Container Closure Integrity (CCI)Bacterial Endotoxin Testing (BET) Display a solid understanding of theories/practices utilized by other disciplines outside primary area of expertise.  Experience participating in professional and/or standards organizations. Knowledge of sterilization (e.g. moist heat/steam or radiation sterilization) Excellent English verbal and written communication skills, skilled to coordinate with global stake holders and support across the different time zones. Highly adept at grasping and solving complex problems using root-cause analysis techniques. Ability to objectively identify technical solutions and make sound decisions Project management experience Self-driven, resourceful, Motivated Leader to lead small teams. Strong organization, attention to detail, and documentation skills. Strong acquaintance with technology, QMS tools and collaboration tools over the web: e.g. Document tools, WebEx, Teams, Microsoft Office products, etc.

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