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Associate Scientist I, R&D - Adl

0-10 years
Not Disclosed
10 Dec. 11, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Associate Scientist I, R&D – ADL

Location: Ahmedabad, Gujarat, India
Job ID: JR-187519

About the Role

Baxter’s Research and Development division is focused on advancing scientific innovation to address complex global healthcare needs. As an Associate Scientist I in the Advanced Development Laboratory (ADL), you will support analytical characterization, method development, and regulatory-driven studies for complex injectable products. This role involves hands-on scientific work, cross-functional collaboration, and contributions to global product development initiatives.

Position Summary

The Associate Scientist I is responsible for executing advanced analytical characterization studies, including method development, method qualification, sameness studies, and routine analysis of complex injectable formulations. The role supports global Baxter teams, contract manufacturing sites, and internal R&D programs.

Key Responsibilities

Quality and Technical Responsibilities

  • Conduct advanced analytical characterization of complex injectables, including proteins, peptides, oligonucleotides, carbohydrates, iron formulations, and impurity profiling across various dosage forms.

  • Manage outsourced studies with CROs, academic institutes, and external research partners, including study design, execution, and reporting.

  • Serve as a subject matter expert to support cross-functional teams in resolving technical challenges in product development.

  • Assist in procurement activities, supplier interactions, and timely acquisition of materials and services.

  • Perform testing and data recording in alignment with SOPs, ALCOA++ principles, GLP standards, and pharmacopoeial guidelines.

  • Maintain detailed documentation in electronic lab notebooks (ELN) and ensure timely sign-off.

  • Conduct trend analysis, verify reagent shelf life, and report deviations or abnormalities to the Sub-Department Manager.

  • Operate, calibrate, and maintain analytical instruments according to SOPs, and communicate maintenance outcomes to supervisors.

  • Prepare and update SOPs, method development reports, and verification documentation.

Administrative Responsibilities

  • Execute tasks assigned by the Sub-Department Manager and coordinate with customers, suppliers, and cross-functional stakeholders.

  • Maintain legible and compliant documentation, ensuring records are always updated.

  • Compile data for management reports and provide daily updates on project status.

Communication Responsibilities

  • Report non-compliance, abnormal results, or technical issues promptly to the Sub-Department Manager.

  • Communicate project challenges and follow approved action plans.

  • Provide daily progress updates to ensure transparency and alignment with project timelines.

Required Qualifications

Education

  • Master’s degree in Pharmacy or Science with 6–10 years of relevant experience
    OR

  • PhD in Biophysics, Biochemistry, or related field with 0–5 years of experience
    (Experience in NMR spectroscopy is essential.)

Technical Expertise

  • Strong competency in NMR spectroscopy, including acquisition, processing, and data interpretation for regulatory submissions.

  • Experience with bio-analytical techniques such as CD, FTIR, fluorescence spectroscopy, and dynamic light scattering.

  • Understanding of chromatographic and orthogonal analytical methods such as SEC-UV-MALS, AF4-MALS, SV-AUC, and related tools used for higher-order structure characterization.

  • Ability to conduct literature searches using scientific databases and regulatory resources to stay updated with advanced analytical methodologies.

  • Experience in troubleshooting analytical techniques and maintaining instrumentation.

  • Strong knowledge of GLP, GDP, pharmacopoeias, and ICH guidelines.

Behavioral Competencies

  • Strong communication and presentation skills.

  • Analytical and problem-solving abilities.

  • Ability to coordinate across teams and maintain a positive, compliant approach.

  • Strong documentation and organizational skills.

Experience Required

  • 6–10 years of experience for candidates with a Master’s degree.

  • 0–5 years of experience for candidates with a PhD.

  • Demonstrated experience with NMR spectroscopic methods is mandatory.

Equal Employment Opportunity

Baxter is an equal opportunity employer and evaluates applicants without discrimination based on race, color, religion, gender, national origin, age, sexual orientation, gender identity, veteran status, disability, or any other protected characteristic.

Accessibility and Accommodations

Candidates requiring reasonable accommodations due to a disability or medical condition may request assistance at any stage of the recruitment process.

Recruitment Fraud Notice

Baxter advises applicants to be aware of fraudulent job communications. The company never requests personal or financial information outside official hiring channels.