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Analytical Scientist Msat

Syngene
Syngene
2-5 years
Not Disclosed
Baltimore, United States
10 March 24, 2026
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

Analytical Scientist – MSAT (Manufacturing Science & Technology)

Location: Baltimore, Maryland, USA
Company: Syngene International Ltd.
Employment Type: Full-Time
Experience Required: Typically 2 to 5 Years (Biopharmaceutical Analytical/MSAT Environment)

About the Company
Syngene International Ltd., established in 1993, is a global innovation-driven contract research, development, and manufacturing organization. The company provides integrated scientific services across pharmaceutical, biotechnology, nutrition, animal health, and specialty chemical sectors. With a strong global client base including leading pharmaceutical companies, Syngene focuses on accelerating innovation, improving R&D productivity, and delivering high-quality scientific solutions. Safety, quality, and compliance are central to its operational philosophy.

Job Overview
The Analytical Scientist – MSAT will support Manufacturing Science and Technology (MSAT), Quality Control (QC), and manufacturing teams by delivering analytical expertise for biologics development and manufacturing. The role involves method transfer, troubleshooting, stability studies, and data analysis while ensuring compliance with cGMP standards and regulatory requirements. The position requires strong technical knowledge, cross-functional collaboration, and the ability to independently execute experiments and present findings to stakeholders.

Key Responsibilities
Support analytical method transfer from development or client laboratories to Quality Control teams
Perform analytical testing for drug substances, drug products, in-process samples, and clinical trial materials in accordance with established procedures
Conduct independent experiments for late-stage biologics manufacturing, process characterization, and stability studies
Troubleshoot analytical methods and support investigations post-method transfer
Participate in analytical method qualification and validation activities
Manage stability studies for drug substances, drug products, and reference standards, including scale-up and engineering batches
Handle deviations, change controls, and ensure compliance with quality systems
Maintain accurate and compliant laboratory documentation, including notebooks, worksheets, and electronic data systems
Ensure data integrity, traceability, and adherence to Good Documentation Practices (GDP)
Review and verify analytical records for accuracy and regulatory compliance
Coordinate with cross-functional teams and external stakeholders to meet project timelines
Monitor analytical methods, compile process data, perform trending, and generate technical reports
Manage inventory and ensure availability of materials required for project execution
Represent the organization in client interactions and scientific discussions

Technical Expertise Required
Hands-on experience with chromatographic and analytical techniques such as RP-HPLC/UPLC, SEC-HPLC/UPLC, CEX-HPLC/UPLC, and peptide mapping
Knowledge of glycan analysis, post-translational modifications, and protein characterization techniques
Experience with capillary electrophoresis, UV spectrophotometry, and protein quantitation methods
Familiarity with analytical detectors such as ELSD and CAD
Practical exposure to bioanalytical techniques including Western blotting, SDS-PAGE, and cell-based assays (e.g., potency assays, luciferase assays)
Experience in Host Cell Protein (HCP), Host Cell DNA (HCD), and residual Protein A analysis

Safety and Compliance Responsibilities
Ensure strict adherence to Environment, Health, and Safety (EHS) guidelines and laboratory safety protocols
Promote a strong safety culture and ensure compliance with quality and regulatory standards
Maintain accountability for safety metrics and continuous improvement initiatives
Follow all SOPs, cGMP requirements, and data integrity standards

Eligibility Criteria
Bachelor’s or Master’s degree in Biotechnology, Chemical Engineering, or a related life sciences discipline

Key Skills and Competencies
Strong expertise in analytical method transfer and troubleshooting
In-depth understanding of biologics characterization and analytical techniques
Excellent documentation, analytical, and problem-solving skills
Ability to work independently and collaboratively in cross-functional teams
Effective communication skills for client interactions and reporting
Strong commitment to quality, compliance, and operational excellence

Why Join Syngene International Ltd.?
Opportunity to work with a globally recognized scientific organization supporting leading pharmaceutical clients
Exposure to advanced biologics manufacturing and analytical technologies
Collaborative and innovation-driven work environment
Strong focus on safety, quality, and professional development

This role is ideal for analytical scientists seeking to advance their careers in MSAT and biopharmaceutical manufacturing, contributing to high-impact global drug development programs.