Analytical Chemist

仕事内容

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.

SUMMARY

• Participate in a variety of projects by conducting testing, designing experiments, developing/evaluating/validating and/or transferring analytical methods independently.
  
• Contribute to Baxter portfolio extension as senior analytical lead of complex and/or large size projects.
  

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.
  
• Provide training and supervision to junior members within the discipline. Routinely provide advice and assistance to team members when facing issues and propose options to meet timelines or provide new timelines in case of troubleshooting.
  
• 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 complex study design 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 planning assigned to the team.
  
• Review critically ELNB and other experimental data to ensure compliance with analytical methods, global and local procedures (GDP, quality system, etc.). Review reports to ensure data accuracy and completeness.
  

Analytical leadership

• Collect information related to product, specification, validations, timelines, release, and stability sites. Analyze documents and identify gaps/risks in term of analytics (vs guideline, internal specifications, …) to build the Analytical Plan / Analytical Business Strategy (ABS) for more complex and/or medium to large size projects.
  
• Identify requirement in terms of equipment and reference standards for sites impacted by the project
  
• Support technical lead on definition of commitments and plan analytical activities for the different sites to ensure these commitments will be met (development, evaluation, validation, documents issuance, waiver redaction, …)
  
• Build the visual planning (Dashboard) and maintain it up to date
  
• Organize follow-up meetings with teams impacted by the ABS
  
• Participate actively to technical team meeting to give a status on analytical activities and ensure interactions with the different functions of the team (PMO, Mgt, RA, Sol Dev, Container, …).
  
• Anticipate and communicate in an appropriate way possible delay on timing due to limited resources or equipment availability, propose alternatives and challenge the appropriateness of activities.
  
• When required, contact external partners and ask for analytical activities quotations.
  
• Evaluate the number of resources required for each analytical activity on the different sites.
  
• Delegate activities to other team members when required (depending on the project size) and this with approval of supervision
  
• Take decision on project independently based on his previous experience and propose activities to reply pro-actively to potential questions from authorities
  

QUALIFICIATIONS :

• Possess a strong technical knowledge on analytical techniques with previous experience on development, validations, or investigation on analytical methods.
  
• Possess a previous experience in project management and understand the roles and interactions with other disciplines as formulation, regulatory affairs, process development, quality control, manufacturing etc.; develop budgets and activity schedules of limited scope
  
• Present a good knowledge of Baxter products, ICH guidelines and submission process
  
• Possess relevant laboratory/technical, writing, and computer skills.
  
• Ability to utilize a logical, methodical approach in independently solving problems, developing solutions, and making recommendations.
  
• Able to identify and solve technical issues thanks to his/her critical mind and “out of the box” thinking.
  
• TrackWise experience strongly preferred
  
• Maintain current knowledge of relevant QSRs and other regulatory requirements related to R&D (product development, design, and safety) to ensure compliance in all research, data collection and reporting activities.
  
• In-depth knowledge and understanding of GxP and related regulations and guidance
  
• Able to work in a team environment and demonstrate an inclusive attitude.
  
• Takes ownership and leadership for getting the job done.
  
• Eagerness to learn is the motor of his/her knowledge development by prospecting for training
  
• Strong communication skills and can write in a clear way
  
• Can manage conflicts and influence other
  
• Autonomous, organized, and precise
  
• Flexible to changes
  
• Scientific honesty
  
• Fluency in French and English
  

EDUCATION AND EXPERICIENCE :

• Master (or PhD degree) in a relevant Sciences domain
  
• Minimum of 2 years of experience in analytical chemistry method development and analytical leadership.
  
  

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.

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