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Sr. Research Assistant - Cce

2+ years
Not Disclosed
10 April 16, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Job Title: Sr. Research Assistant - CCE
Location: Ahmedabad, Gujarat, India
Employment Type: Full Time


Company Overview:

At Baxter, we are united by a mission to save and sustain lives. For over 85 years, Baxter has led the way in medical innovations that improve healthcare worldwide. Our products and therapies are found in hospitals, clinics, and homes across the globe. Join a team where your work creates a meaningful impact and advances the health of millions of patients. At Baxter, we empower you to bring your best self to work, where you can thrive in an inclusive environment and make a difference.


Position Summary:

The Sr. Research Assistant - CCE will support the Container Closure Engineering (CCE) Team in various technical and operational activities related to extractable and leachable analysis using advanced analytical techniques like ICP-MS/OES, GC-MS, LC-MS/MS-MS. The successful candidate will bring strong theoretical knowledge of modern analytical methods, an eagerness to contribute to new product development, and a deep understanding of pharmaceutical industry regulations. This role demands good communication skills, a willingness to learn, and a collaborative mindset to face challenges encountered during R&D projects.


Key Responsibilities:

Technical Development and Analysis:

  • Serve as the primary expert on packaging in the development teams, overseeing primary, secondary, and tertiary packaging of Baxter Pharmaceutical products.

  • Support innovator pack/reference package characterization, making observations, analyzing data, interpreting results, and preparing technical reports, summaries, SOPs, and protocols.

  • Develop and standardize testing procedures, ensuring the specification of test requirements and acceptance criteria in line with quality and regulatory standards.

Regulatory Compliance and Testing:

  • Ensure test method qualification and method transfer to GMP testing for packaging verification and validation, adhering to regulatory requirements.

  • Ensure that work complies with USP/PharmEur, ISO/MDD/GMP/GLP, 21CFR 820.30, ISO 14971, and safety requirements.

Product Development and Troubleshooting:

  • Define, plan, and execute analytical development and characterization of pharmaceutical injectables, ensuring compliance with international regulations.

  • Conduct failure analysis and root cause investigations during new product development and sustaining projects.

  • Troubleshoot analytical issues and product development challenges in a science-based manner, proposing innovative solutions with senior colleagues.

Collaboration and Communication:

  • Engage in cross-functional communication to ensure timely completion of activities.

  • Prepare scientific reports, proposals, and presentations.

  • Ensure the maintenance and calibration of laboratory instruments and equipment.

  • Follow Baxter’s Quality Manual, SOPs, and Environmental Health, Safety & Sustainability (EHS&S) guidelines.


Qualifications:

  • Bachelor’s/Master’s degree in relevant scientific discipline (e.g., Chemistry, Pharmaceutical Sciences).

  • Hands-on experience with advanced analytical techniques (e.g., ICP-MS/OES, GC-MS, LC-MS/MS-MS).

  • Strong understanding of pharmaceutical packaging, regulatory compliance, and GMP guidelines.

  • Excellent verbal and written communication skills.

  • Experience in scientific reporting, data analysis, and use of statistical tools.

  • Ability to work well in cross-functional teams and a fast-paced environment.

  • Familiarity with tools like UTM, VMM, CCIT, Leak testers, and Vibration testers.