SME USP MSAT

JOB DESCRIPTION

Job Title: SME USP MSAT

Job Location: Bangalore

Department: Biopharmaceutical Development

About Syngene:  Syngene (www.syngeneintl.com) is an innovation-led contract research, development and manufacturing organization offering integrated scientific  services from early discovery to commercial supply.

At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit

Mandatory expectation for all roles as per Syngene safety guidelines

• End-to-end MSAT ownership of upstream processes from cell line handover through technology transfer, validation, comparability, and commercial lifecycle management.
• Process scale-up/scale-down, characterization, and execution of Continued Process Verification (CPV).
• Documentation: Author/review BMRs, MBRs, SOPs, risk assessments, comparability protocols, and technical reports.
• Manufacturing support: Provide on-floor support, troubleshooting, and deviation investigations.
• Performance monitoring: Lead process monitoring, trending, and data analysis.
• Validation strategies: Design and execute Stage 1–3 process validation.
• Regulatory support: Contribute to IND/BLA/MAA filings and respond to health authority queries.
• Statistical expertise: Apply DoE, multivariate analysis, regression modeling, and advanced statistical tools in process monitoring, troubleshooting, characterization etc.
• Process characterization: Drive studies for design space development and CPP identification.
• Risk management: Lead structured risk assessments (FMEA, HACCP, risk ranking) and mitigation strategies.
• QbD principles: Define control strategies and ensure robust process design.
• Deviation/CAPA ownership: Lead root cause investigations, CAPA, and change control.
• Cross-functional collaboration: Interface with PD, QA, QC, Manufacturing and Regulatory teams.
• Leadership: Act as project co-lead, accountable for timelines, deliverables, and stakeholder alignment.
• Mentorship: Mentor junior scientists and contribute to MSAT capability development.
• Troubleshooting: Lead resolution of tech transfer issue, complex yield, productivity, and product quality issues.
• Optimization: Implement process improvements and cost-of-goods reduction initiatives.
• Digital initiatives: Drive automation, digitalization, and knowledge management in MSAT

Core expectations: Proven experience leading multiple upstream technology transfer projects (mammalian), with clear understanding of key constraints and execution challenges. Proficient working knowledge of microbial upstream processes, technology transfer, and associated constraints (Minimum 1–2 successful technology transfer projects completed end-to-end). Mandatory expertise in advanced statistical tools and data analysis to support process monitoring, process characterization, validation, and lifecycle management.

Syngene Values

All employees will consistently demonstrate alignment with our core values

•  Excellence
•  Integrity
•  Professionalism

Experience

• Relevant practical experience in Upstream MSAT.

Skills and Capabilities

• Good understanding of global regulatory guidelines (FDA, EMA, ICH) and ability to align MSAT deliverables with compliance requirements.
• Strong ability to co-lead projects, manage timelines, and ensure stakeholder alignment across functions.
• Ability to clearly articulate technical findings, author high-quality reports, and present to internal/external stakeholders.
• Excellent written and verbal communication skills for regulatory documentation and presentations.
• Openness to digitalization, automation, and continuous improvement initiatives.
• Flexibility to manage diverse modalities (mAbs, bispecifics, fusion proteins, microbial systems) across clinical and commercial stages.
• Ability to adapt schedules and priorities to meet dynamic production needs, ensuring seamless execution of technology transfer, troubleshooting, and deviation management.

Education

• Master’s degree in Life Science, Chemical Engineering, Biotechnology, or related field.

Equal Opportunity Employer:

It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.