About Baxter Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-centre dialysis;
sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacyautomation, software and services.
The company’s global footprint and the critical nature of its products and servicesplay a key role in expanding access to healthcare in emerging and developed countries.
Baxter’s employees worldwideare building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcareinnovations that enable patient care.
Develop effective program milestones, schedules and budgets for all analytical transfer work activities.
Employ state-of-the-art project management tools to manage the project schedules analytical transfers and budgets against milestones;
review and apply best-demonstrated practices, team processes, and improve operational efficiency.
Identify and resolve issues that may jeopardize project schedules or improve project time. Seek regular input and feedback from customers and take appropriate action
For a project : be responsible for strategy and directing the analytical development. Assure scientific, regulatory, and quality aspects are met.
Recognized as a Key Analytical Lead for Strategic and Global Baxter projects (BTP)
Works transversally with a cross-functional team consisting of stability operations, regulatory affairs, compendial group, quality, and External Partner.
Provide training and supervision to junior members within the discipline. Routinely provide advice and assistance to team members regarding unique problems
EXPERTISE & INNOVATION
Ensure development of state-of-the-art analytical expertise and function specialties at our Strategic Indian partners; deploy effectively
Recognized for technical expertise across multiple areas of technical specialty - Apply an in-depth understanding of multiple disciplines and businesses.
Documentation of studies through protocols and final reports. Compiles
scientific data and interpret results in a clear, concise report.
Key contributor for issuance of test methods (e.g., 11 series / MOP methods)
Create and execute complex design and technical tasks, integrating information from a variety of disciplines
Provides analytical interpretation of results from studies to stakeholders.
Independently plan and execute a series of design and / or technical tasks that may not be well-defined, have multiple variables and require advanced techniques within negotiated deadlines.
Develop new approaches to complex problems through adaptations and modifications of standard technical principles to address business need.
Develop technical feasibility analysis for complex research and design concepts.
Evaluate results relative to product requirements, definitions and / or program goals.
Play a lead role in the evaluation, selection and adaptation of various techniques, which accomplish business objectives such as quality and cycle-
time. Write and review protocols and reports for scientific studies.
Adhere to the Quality System, understand potential impact and apply applicable corporate, divisional and departmental procedures as relevant.
The scope of understanding should cover Raw materials, API, Finished products
development of robust and efficient analytical methods
Validation according to the business and regulatory needs
transfer of methods and tests into relevant partners
Define and communicate strategic imperatives to project success of analytical validations, transfer, or research projects which are non-
routine within areas of expertise to address specific technical requirements for pharmaceutical
product development and product lifecycle management. Develop strategic plans that incorporate regional and global business practices and customer needs.
Identify, supervise and manage all scientific aspects of project related studies supported by internal resources in RL / BAP / CHINA or external partners.
Must demonstrate strong leadership.
Must demonstrate strong decision making skills
Must be able to develop strategic direction for the organization.
Must be self-motivated, have excellent interpersonal skills, capable of analyzing and solving complex problems through innovative thought and experience, as well as, project management tools.
Demonstrated in-depth experience in method development, validation of minimally HPLC, GC, KF, and titration methods
Possess relevant laboratory / technical / writing and computer skills
Ability to organize and communicate complex information that engages a large audience
Utilize a logical and methodological approach to help solving problems, developing solutions and making recommendations.
Ability to make sound technical decisions on limited information with minimal guidance.
Ability to articulate customer needs and incorporate into work
Ability to effectively mentor junior level associates
Ability to make decisions independently
Ability to design experiments and draw meaningful conclusions from lab data from multiple disciplines.
Contribute to efforts beyond own scope of responsibility to ensure project milestones are met
A thorough understanding of compendial (minimally USP and EP) and ICH (minimally Q1, Q2) guidelines.
Proven experience working with cross functional teams.
Experience in issuing test methods (e.g., 11 series / MOP methods).
Experience in developing timelines to complete projects.
Leadership skills and demonstrated ability to work with indirect reports.
Experience of working with different cultures is desirable.
Languages Skills Spoken Written Read
English Excellent Excellent Excellent
Education / Experience PhD + experience or MS + minimally 5 years of experience in analytical chemistry method development.
A Career That Matters Baxter’s employees are united in a mission to save and sustain lives. We are passionate about applying scientificinnovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies andtechnologies.
We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuingcreative collaborations that bring our mission to life for patients every day.
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, disability / handicap status or any otherlegally protected characteristic.
Research and Development