Manager, Materials E&L
Plymouth, MN 
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Posted 6 days ago
Job Description

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.

This individual will lead an Americas-based team of scientists and engineers working on materials and Extractables & Leachables aspects for sustenance and expansion of Kidney Care's product portfolio in Peritoneal dialysis, Hemodialysis, and Acute therapies space. The incumbent will be responsible for building, leading, and growing talent as well as providing technical & programmatic leadership of on-going projects in this team.

This individual will work closely with global and cross-functional colleagues to devise R&D strategies relative to efficient and effective execution of business plans to ensure products continuity on market, potential market expansion (through geo-expansion or new products) and margin improvement projects.

This is an opportunity to become part of a highly matrixed multidisciplinary team that is responsible for ensuring the safety of both drugs and medical devices. The role will report to Director of Biocompatibility, E&L and Materials global organization responsible drugs and devices for Peritoneal dialysis, Hemodialysis, and Acute therapies (~$5B product portfolio with global reach in more than 100 countries). The successful candidate will lead a small team of about 8 materials and E&L scientists and engineers primarily based in Baxter's R&D facility in Plymouth, MN.

Essential Duties and Responsibilities:

  • Lead talent selection, development, retention efforts, establishing clear criteria for measuring team and individual success. Provide feedback, recognition, and opportunities for cross-training. Mentor and empower team members, ensuring their developing expertise aligns both with their career interests and with business needs. Set high standards and goals and remove barriers to excellence.

  • Understand and effectively communicate how projects fit into the organization's strategies. Ensure that team objectives align with key business strategic programs.

  • Develop project schedules and budgets, optimize the use of financial resources, and balance in-house and outsourced resources.

  • Design, lead and coordinate E&L and material testing with external and internal laboratories within US. Provide program leadership for all testing conducted in US.

  • Review and implement standard methodologies and team processes to enhance operational efficiency, resolve issues, improve project timelines, and make timely, risk-based decisions. Solicit regular input from customers and take appropriate action.

  • Be accountable for successfully meeting agreed upon landmarks. Collaborate with other functional managers and project managers to ensure project priorities and project schedules are met.

  • Provide leadership by guiding in terms of prioritization, problem resolution, process clarification, referrals to appropriate guides, etc.

  • Generate innovative and expeditious solutions to sophisticated problems by using multiple fields and technical principles. Develop innovative processes and methods through fusion of expertise.

  • Accountable for laboratory management including standard methodologies, efficient operations, and compliance with GxP and EHS.

  • Maintain current knowledge of relevant Quality System Regulations and other regulatory requirements to ensure compliance in all research, data collection and reporting activities.

  • In addition to having an in-depth knowledge and understanding of GxP and related regulations and guidance (e.g., ISO 10993-1, ISO 10993-17, ISO 10993-18, ICH, OECD TGs), provide experienced insights into such regulations so as to facilitate efficient product registration and/or is an active participant in the generation, review, adoption, and interpretation of such regulations.

  • Demonstrate agile approach in project executions - both in field issue resolutions and new product/material development.

  • Shape external teamworks with world-class research institutes and contract research labs to explore the state-of-the-art approach in an efficient manner.

Qualifications:

  • Must demonstrate effective supervisory and leadership skills.

  • Able to coordinate and communicate sophisticated information to various audiences including senior management.

  • Possesses strong time management skills.

  • Able to make decisions with limited information.

  • Capable of analyzing and solving sophisticated problems through entrepreneurial thought and experience, as well as with project management tools.

  • Works well in a team environment and effectively leads scientists working in multi-functional teams.

  • Possesses an agile mentality.

  • Should understand ICH, FDA, relevant cGxPs, ISO, and quality systems associated with pharmaceutical and medical devices development.

  • Demonstrated ability to provide technical leadership for technical projects with significant complexity and scope.

  • Demonstrated ability to provide program leadership including resource allocation, budget, schedules and supervising progress through project management tools

  • Demonstrated ability to innovate - through structured innovation process, leading and facilitating brainstorming sessions, coalescing diverging set of ideas into a solution that can be pursued and matured.

  • Understand implications of raw material change in pharmaceutical and medical devices industries (product impact, process impact, regulatory implications, end user, sterilization etc.)

  • Proven track record to solve business problem at hand.

  • Demonstrated ability to decompose complex problems into task lists and lead a team of junior and senior scientists/engineering in ensuring on-time execution with attention to quality and first time-right.

  • Demonstrated ability to draw conclusions and make recommendations based on technical inputs from multiple and varied functions (i.e., manufacturing, quality, regulatory, etc.)

  • Ability to lead change initiatives.

  • Excellent technical protocol & report writing skills (in English) especially with consideration to quality and regulatory requirements.

  • Ability to work in a multi-cultural global environment.

  • Ability to mentor and develop new team members.

Education and/or Experience:

  • An educational background in any one of the following fields: Chemistry, Material science and engineering, Polymer science and engineering, Biomedical engineering, Chemical engineering, or other relevant STEM fields.

  • Bachelor's degree with 9+ years of proven experience,

  • Master's degree with 6+ years of proven experience, or

  • Ph.D. with 3+ years of experience

  • A relevant experience should include hands-on, program leadership and supervisory experience in any one of the primary areas for this role: e.g., design, testing and regulatory compliance of medical devices made with polymeric materials, Extractables & Leachables work for medical devices and drug products.

  • Experience with project management tools & processes.

  • Experience with people leadership in supervisory roles is highly desired but not required.

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $120,000.00 - $160,000.00 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses, commission, and/or long-term incentive (REMOVE IF NOT APPLICABLE). For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.

The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.

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
EEO is the law - Poster Supplement
Pay Transparency Policy

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

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

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Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
9+ years
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