Baxter is hiring Research Scientist I
Position: Research Scientist I
Location: Bengaluru, Karnataka, India
Job Category: Research and Development
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 <1663> and <1664> 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 reviewing peers’ work.
Provides and accepts critical feedback from others in a constructive manner.
Adapts to changes and has an Agile mindset.
Works in a team environment and demonstrates an inclusive attitude.
Embraces diversity and inclusion, values differences.
Education and Experience
Bachelor’s degree in a scientific discipline with 10 years experience, MS with at least 5-7 years, or PhD with 0-2 years in relevant discipline required.
Previous experience with analytical test method development and validation.
QSR research lab experience essential and GMP experience desirable.
Research lab experience includes research in GMP/QSR environment and cross-functional teamwork.
Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.
Address:Tower B, 16th Floor
Karnataka- 560 048
Karnataka
India