Senior Associate Scientist - Chemical Analytical

Roles and Responsibilities:

1.1 Compliance and Quality

• Perform all activities in compliance with GxP requirements.
• Follow quality and safety requirements in accordance with organizational policies, procedures, and regulatory guidelines.
• Ensure technical outputs align with Global Training Curricula for instrument operation, material handling, and certifications related to Quality Operations, Manufacturing, and EHS.
  
  

1.2 Analytical Development and Troubleshooting

• Troubleshoot analytical issues related to methods and instrumentation.
• Develop and validate analytical methods using LC-MS, GCMS and ICP-MS for E&L work flow and Nitrosamine work flow support.
• Develop GTI impurity methods using LC-MS and GC-MS.
• Assess existing data packages, evaluate feasibility, and recommend remediation where needed.
• Has strong knowledge of USP, PQRI, and BPOG guidelines for SUS and MUS systems, along with expertise in writing non-laboratory, paper-based assessment reports for packaging commodities.
  
  

1.3 Documentation, Governance, and Review

• Work with Quality Assurance and cross-functional teams to support consistent and disciplined execution of the LIR/ER/CAPA quality system, ensuring assigned tasks are complete and thorough.
• Maintain compliance with local and corporate procedures and keep all data packages audit-ready and transferable.
• Ensure formal milestone reports receive appropriate GT and ELT review to support decision-making.
  
  

1.4 Cross-Functional Coordination

• Coordinate with cross-functional teams to ensure timely execution and resolution of deliverables against target milestones
  
  

Knowledge and Skills:

Technical Skills

LCMS, GCMS and wet Chemistry

Must have HPLC and GC

Standards, Processes and Policies

GDP

GLP

cGMP

SOP

Behavioral/Any Other Skills

Think Big,Speak up,

Be decisive

Focus on what matters

Agree Who Does What

Measure

Outcomes

Be inclusive

Act with integrity

Take pride

Recognize one another

Qualification:

Master's in chemistry/pharmacy/Ph.D

Type of Experience:

Brings 5–7 years of experience in Analytical Research and Development, with strong expertise in nitrosamine workflow support and extractables and leachables studies. Demonstrates hands-on proficiency in HPLC, GC, GCHS, and LCMS within GMP environments, supported by strong data interpretation and technical report-writing skills.

Work Location Assignment: On Premise

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Research and Development