Research Scientist I

6 months ago

Bengaluru Karnataka, India BAXTER Full time

**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.
- With mínimal oversight, lead and coordinate extractables and leachables studies internally as well as at external contract laboratories.
- Actively collaborate across multiple functional areas including chemistry, biocompatibility, regulatory, program management, manufacturing and toxicology.
- Develop strategies and research projects related to product support, new product development, and extractable and leachables, which are non-routine within areas of expertise to address specific technical requirements of a project.

**Duties and Responsibilities**
- Act as a study director, designing and executing extractables and leachables, method development, validation, and transfer studies including authorship of protocols and reports, by incorporating input from various SMEs.
- Conduct impurities studies (routine and non-routine) by performing chemical analysis utilizing LC and GC with various detections including MS and associated wet chemistry and sample preparation techniques. Perform structural elucidation of compounds.
- Collaborate with other functions such as project management, regulatory, extractables, toxicology, biocompatibility, manufacturing and quality in project teams.
- Develop analytical methods and validate in accordance with USP, ICH and other regulatory guidance
- Lead investigations that correspond to atypical or out-of-specification/out-of-trend results. Leverage critical thinking skills to drive the investigation to conclusions based on sound scientific principles.
- Create, update, and maintain analytical procedures and associated equipment.
- Maintain knowledge of and demonstrate adherence to relevant Quality System Regulations and other regulatory requirements related to R&D (product development, design and safety) to ensure compliance in all research, data collection and reporting activities. This applies to governmental and international industry requirements, procedures, regulations, and standards e.g., related to method validation (USP, ICH).
- In addition to having an in-depth knowledge and understanding of cGxP and related regulations and guidance, is able to provide expert advice and/or is an active participant in the generation, review, adoption and interpretation of such regulations.
- Leverage operational excellence in the execution of laboratory activities.
- Evaluate analytical results, identify trends, exceptions, and interpretation of results relative to product requirements, definitions and/or project goals.
- Experienced and competent in interpreting analytical data and presenting in a form that is suitable for a wide-ranging audience.
- Communicate clearly with management, peers, cross-functional teammates, and non-technical audiences by openly sharing project status and hurdles and seeking input from other team members.
- Coach and or supervise other team members in areas of expertise.

**Qualifications**
- Writing and computer skills relevant to recording original data as well as creating protocols, reports, and presentations to communicate with partners and team members.
- The ability to energetically attack a problem and synthesize the results into a clear and logical summary in a timely manner is critical.
- Well versed in chemical characterization of medical devices and drug packaging standards and guidelines. Required knowledge and demonstrated experience of analytical chemistry with relevant laboratory skills (hands-on experience with wet chemical techniques and instrumental analysis including LC/MS/UV, GC/MS/FID, and/or ICP-MS).
- Experience or understanding of regulations and chemical characterization for extractables and leachables for Container Closure Systems (per USP
and
and Medical Devices (per ISO 10993-18)).
- Quality and detail oriented.
- Experienced with analytical method development, validation, and transfer.
- Possesses a good understanding of ICH, USP guidelines and cGxP practice.
- Experience with MassHunter, Sciex Analyst, Empower, E-noval and other analytical instruments software systems.
- Ability to learn quickly and to solve problems in a timely manner using critical thinking and analytical chemistry skills.
- Designs experiments and draws meaningful conclusions from lab data in addition to critically r

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