Mgr Stability Lab

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:

The position may be responsible for management of Stability Operations and Laboratory teams. May be responsible for analytical testing, validation/verification/transfer of test methods, and qualification of environmental chambers and laboratory equipment supporting parenteral products. The position will be located in Round Lake, IL within Global Quality Stability serving multiple global businesses and manufacturing sites.

What you will be doing:​

• Provide directions to team using Quality Laboratory short-term objectives, general policies and management guidance related to lab operation.
• Manage stability operations team supporting sample handling and chamber storage within the stability program.
• Interpreting and driving compliance to applicable quality and regulatory requirements (e.g., FDA, QMS, cGMP, USP, and ICH guidelines), developing procedures to implement these requirements for the stability operation.
• Develop effective project schedules and manage budgets, including capital.   Employ project management tools to manage to those project schedules and budgets; review and apply best-demonstrated practices, team processes, and improve operational efficiency.
• Select, develop and retain team. Define and communicate criteria by which team and individual success will be measured. Provide constructive feedback and recognition. Effectively coach, mentor and motivate others for outstanding performance.
• Ensure compliance with testing SOPs and specifications. Supervise the testing techniques and accuracy of all records and documentation that is done in the lab.
• Seek regular input and feedback from customers and take appropriate action. Identify and initiate discussion of key business issues affecting the project (e.g. timing of market entry, innovative technology and costs).
• Participate in laboratory metrics to monitor, achieve, and improve KPI’s that support global stability governance.
• Generate innovative solutions to sophisticated problems through the use of multiple disciplines and technical principles. Develop innovative products, processes, and methods through novel combinations of expertise within the organization.
• Collaborate with other functional managers and project managers to ensure project priorities and project schedules are met.
• Manage team members to effectively transfer technology from design development to implementation.

What do you bring:

• Bachelor of Science in Chemistry or Biological Science and at least 10 years experience or 5-7 years experience with Masters.
• Proficient in sophisticated wet chemistry, volumetric preparation techniques and instrumental methods of analysis.
• Experience/knowledge with stability chamber qualification, method validation and transfer.
• Possess good understanding of ICH, cGxP, and compendial guidelines (e.g. USP).
• Knowledge and experience with HPLC/UPLC, particle analysis, pH, UV, Empower, LIMS and other analytical chemistry techniques, instruments, and software.
• Must demonstrate efficiency in ability to train and develop self and others, leadership,
  organization, teamwork/interpersonal skills, quality results orientation, and task completion.
• Must be able to prioritise multiple tasks concurrently and in a timely fashion.
• Possess good presentation, writing and digital literacy.
• Must communicate and collaborate effectively with Sr.management, peers, and subordinates.
• Ability to interpret available lab data, draw conclusions, make recommendations, and lead resolution to technical challenges. Must be proficient in scientific disciplines.
•   Capable of analyzing and solving sophisticated problems through innovative thought and experience,     conduct investigations into root cause and implement effective corrective actions.

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay