Upstream Scientist – MSAT (Biopharmaceutical Manufacturing)
Location: Baltimore, Maryland, USA
Company: Syngene International Ltd.
Employment Type: Full-Time
Experience Required: Typically 2 to 5 Years (Biopharmaceutical MSAT/Manufacturing Environment)
About the Company
Syngene International Ltd. is a globally recognized contract research, development, and manufacturing organization established in 1993. The company delivers integrated scientific services across pharmaceutical, biotechnology, and specialty chemical sectors. With a strong global client base, Syngene focuses on accelerating innovation, improving R&D productivity, and ensuring cost-effective drug development. Safety, compliance, and scientific excellence are central to its operations.
Job Overview
The Upstream Scientist – MSAT will provide technical and scientific support to Manufacturing Science and Technology (MSAT), Quality Control (QC), and manufacturing teams. The role focuses on upstream bioprocessing, analytical support, method transfer, and troubleshooting for biologics manufacturing. The candidate will work on process optimization, scale-up activities, and data analysis while ensuring compliance with cGMP and regulatory standards.
Key Responsibilities
Support upstream process development and manufacturing activities for biologics, including process performance and characterization studies
Coordinate with MSAT, manufacturing, and QC teams to deliver analytical and technical support aligned with project requirements
Execute experiments independently for late-stage biologics manufacturing, process optimization, and stability studies
Participate in analytical method transfer, qualification, and troubleshooting activities
Assist in investigations and resolve technical issues arising post-method transfer
Perform testing for drug substances, drug products, in-process samples, and clinical trial materials as per established procedures
Manage stability studies for drug substances, drug products, and reference standards, including scale-up and engineering batches
Handle deviations, change control processes, and ensure compliance with quality systems
Maintain accurate laboratory documentation, including notebooks, worksheets, and electronic records in line with data integrity requirements
Review analytical data, verify calculations, and ensure compliance with Good Documentation Practices (GDP)
Monitor process performance data, conduct trending analysis, and generate technical and summary reports
Collaborate with cross-functional teams, vendors, and stakeholders to meet project timelines
Manage inventory and ensure availability of materials for ongoing projects
Represent the organization in scientific discussions and client presentations
Technical Expertise Required
Strong understanding of upstream bioprocessing and biologics manufacturing
Hands-on experience with analytical techniques such as HPLC/UPLC (RP, SEC, CEX), peptide mapping, and protein characterization
Knowledge of glycan analysis, post-translational modifications, and protein quantification
Experience with capillary electrophoresis, UV spectrophotometry, and related analytical tools
Familiarity with bioanalytical techniques including SDS-PAGE, Western blotting, and cell-based assays (potency assays, luciferase assays)
Understanding of 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) policies and laboratory safety protocols
Promote a safety-first culture and maintain compliance with company quality and regulatory standards
Ensure data integrity, traceability, and adherence to cGMP requirements
Monitor and contribute to safety metrics and continuous improvement initiatives
Eligibility Criteria
Bachelor’s or Master’s degree in Biotechnology, Chemical Engineering, or a related life sciences discipline
Key Skills and Competencies
Expertise in upstream processing, analytical method transfer, and troubleshooting
Strong analytical, problem-solving, and documentation skills
Ability to work independently and collaboratively within cross-functional teams
Effective communication skills for reporting and client interactions
High attention to detail with a strong focus on quality and compliance
Why Join Syngene International Ltd.?
Work with a globally recognized scientific organization supporting leading pharmaceutical and biotech clients
Exposure to advanced biologics manufacturing and MSAT operations
Collaborative, innovation-driven work environment with strong emphasis on safety and quality
Opportunities for career growth and professional development
This role is ideal for professionals looking to build expertise in upstream bioprocessing and MSAT within a global biopharmaceutical manufacturing environment, contributing to cutting-edge drug development and commercialization initiatives.
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