Assoc. Research

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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.

**ESSENTIAL DUTIES AND RESPONSABILITIES**
- Coordinate test plan execution including current physical, chemical, and physicochemical techniques in accordance with GLP and local procedures.
- Participate in analytical method development feasibility and validation studies
- Participate / support / organize the formulation design, test plan and the production of development batches of different formulations.
- Interpret experimental data and present conclusions to supervisor, project leader and management.
- Write comprehensive protocols and reports in English.
- Adhere to the quality system requirements and ensure GMP and GDP standards; also adhere to general and specific environmental, health and safety (EHS) guidelines.

**Other requirements**
- Use current physical, chemical, and physicochemical techniques in accordance with GLP and local procedures; document results in electronic laboratory notebooks according to established GDP procedures.
- Create and update equipment and analytical procedures, participate in the ordering of raw materials, analytical material, or equipment pieces.
- Provide support for initiatives in innovation, investigations and troubleshooting, technological development, competitive product analysis, sustaining product, etc.

Develop analytical methods and act as analytical lead per the following:
Analytical method development
- Contribute to technical feasibility analysis of complex research and design concepts.
- 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.
- Collect information required for the analytical target profile from project manager, supervision, product owner.
- Propose new techniques and develop analytical method without assistance. Play a lead role in the evaluation, selection and adaptation of various techniques, which accomplish business objectives such as quality and cycle-time.
- Devise new approaches to complex problems through adaptations and modifications of standard technical principles. Incorporate new methods and technologies for improving existing or new products/processes.
- Work with applicable software, e.g., SIMS, LIMS, equipment’ software, development and statistical tools (e-Noval, MVS, Fusion, Minitab).
- As study director, evaluate test design (sample number, test to perform), ensure testing follow-up and communication of results.
- Collect data from development and take decisions based on the obtained results, prepare support and present development status in technical review meeting.
- Design study and write protocols, reports, and procedures autonomously as study director.
- Lead evaluation, validation, or transfer of analytical method according to study protocol. Ensure all reagents, raw materials and equipment are available to run testing design, perform experiments, document activities in an appropriate way and advise supervisor in case of deviation or failed acceptance criteria.
- Support receiving site in the scope of method transfer by sharing experience from development and technical knowledge on the method.
- Process development/validation/transfer results and review it in a critical way, ensure deviations are documented correctly.
- Conduct the investigation on failed acceptance criteria without assistance. Analyze data, propose hypotheses, and document investigation accordingly.
- Write validation and method summaries dedicated to submission files without assistance.
- Collect data to answer to authorities’ questions on analytical methods, write responses in a clear and structured way autonomously.
- Work with global teams across varying functions (ex. quality, regulatory, operations, manufacturing, etc.) to maintain business continuity.
- Initiate/Lead/Support Projects and Change Controls aligned with capacity expansion, SNC’s or other design/process changes for on market product.
- Contribute to efforts beyond own scope of responsibilities to ensure project milestones are met.
- Perform laboratory testing in a qualified environment following procedures (equipment and analytical procedures) and local or global processes, with respect to timeline and planni