Research Associate
il y a 3 semaines
**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.
**Method Development and Validation**
Collects information required for the analytical target profile from Project (analytical lead, project manager, product owner )
Develops robust & efficient analytical methods with no/limited assistance utilizing modern & state of the art statistical approach to bring them to successful validation
Collects data from development and take decisions / propose solutions based on obtained results. Prepares support and present development status in technical team review meetings
Assures that complex technical data are reported with scientific excellence and has the ability to communicate the outcome of the analytical activity conducted to team/supervisor/customer.
Understands and masters all regulations requirements pertaining to analytical method performance.
Contributes and/or collaborates to analytical method validation/co-validation/transfer both internally or with CRO
Designs complex study design and write associated Quality documents (protocols, reports, procedures.)
Document results in laboratory notebooks according to established GDP procedures
Advises supervision and customer when facing issue and propose options to meet timeline/define new timeline when facing issues
Ability to mentor junior team members on method development & validations aspects
Participates to method comparability/equivalence studies to enable the continuation of the analytical method lifecycle.
Participates to resource need estimation & planning definition to provided expected deliverables.
Interacts with cross functional teams of analytical experts with internal / external labs / suppliers.
Effectively coordinates and tracks the progress of multiple analytical related projects and activities
Ability to identify risks, issues and opportunities and communicate to supervisor and customer
**Other Duties**
Collaborate to investigations in complex analytical issues that correspond to atypical or out-of-specification/trend test results as well as instrumentation and methodology related issues. Leverages critical thinking skills to find the right solutions for the business above functional considerations.
Leads by exemplifying the Baxter Culture Levers (Collaboration, Courage, Simplicity, Speed)
Embraces shared accountability for program results and commitments. Drives an environment of mutual accountability in the analytical team.
Adhere to the quality system requirements as well as to general and specific environmental, health and safety guidelines
**Qualifications.**
- Possesses a strong technical knowledge on various analytical techniques, especially in Liquid and Gas chromatography as well as in other techniques (LC, UV, titration, Karl Fisher ) with significant experience in development, validation/verification/transfer as well as troubleshooting.
- Understands the roles and interactions with other disciplines like Formulation, Process Development, Regulatory Affairs, Quality Assurance
- Strong knowledge of Compendial and other regulations applicable to analytical activities within Pharmaceutical environment
- Able to identify and solve technical issue thanks to critical mindset and “out-of-the-box” thinking
- Able to work in a team environment and demonstrate an inclusive attitude.
- Good cross-cultural interpersonal skills, with ability to operate in a cross-functional teams, internally and externally to Baxter.
- Basic project management skills.
- Takes ownership and leadership for getting the job done
- Ability to analyze and solve complex problems through a demonstrated problem-solving methodology (for instance Six Sigma), experience and innovation.
- Ability to operate in Certified environment by complying with quality system in place
- Very good level or written and spoken English.
- Eagerness to learn new analytical techniques and competencies
- Scientific curiosity and honesty
**Education**
- Master in Science: for instance, Analytical, Organic chemistry, Biochemistry, Pharma Science
- 5 to 10 years of experience in pharmaceutical industry, R&D, manufacturing
- Knowledge of new analytical strategies as described in ICH Q14, QbD...
**Reasonable Accommodations**
**Recruitment Fraud Notice**
Baxter has discovered incidents of employme
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