About this role
<p style="margin:0.0cm 0.0cm 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-family:Calibri, sans-serif">JOB DESCRIPTION</span></strong></p> <p style="margin:0.0cm 0.0cm 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-family:Calibri, sans-serif"> </span></strong></p> <p style="margin:0.0cm;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-family:Calibri, sans-serif">Job Title:</span></strong><span style="font-family:Calibri, sans-serif"> SME USP MSAT</span></p> <p style="margin:0.0cm;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-family:Calibri, sans-serif">Job Location:</span></strong><span style="font-family:Calibri, sans-serif"> Bangalore</span></p> <p style="margin:0.0cm;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-family:Calibri, sans-serif">Department: </span></strong><span style="font-family:Calibri, sans-serif">Biopharmaceutical Development</span></p> <p style="margin:0.0cm 0.0cm 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-family:Calibri, sans-serif"> </span></strong></p> <p style="margin:0.0cm 0.0cm 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-family:Calibri, sans-serif">About Syngene: </span></strong><span style="font-family:Calibri, sans-serif">Syngene (<strong><a href="http://www.syngeneintl.com"><span style="font-weight:normal">www.syngeneintl.com</span></a></strong>) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply. </span></p> <p style="margin:0.0cm 0.0cm 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-family:Calibri, sans-serif"> </span></strong></p> <p style="margin:0.0cm 0.0cm 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><em><span style="font-family:Calibri, sans-serif">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</span></em></strong></p> <p style="margin:0.0cm 0.0cm 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-family:Calibri, sans-serif"> </span></strong></p> <p style="margin:0.0cm 0.0cm 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><u><span style="font-family:Calibri, sans-serif">Mandatory expectation for all roles as per Syngene safety guidelines</span></u></strong></p> <ul style="margin-top:0.0cm;margin-bottom:0.0cm" type="disc"> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-family:Calibri, sans-serif">End-to-end MSAT ownership</span></strong><span style="font-family:Calibri, sans-serif"> of upstream processes from cell line handover through technology transfer, validation, comparability, and commercial lifecycle management.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-family:Calibri, sans-serif">Process scale-up/scale-down</span></strong><span style="font-family:Calibri, sans-serif">, characterization, and execution of Continued Process Verification (CPV).</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-family:Calibri, sans-serif">Documentation</span></strong><span style="font-family:Calibri, sans-serif">: Author/review BMRs, MBRs, SOPs, risk assessments, comparability protocols, and technical reports.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-family:Calibri, sans-serif">Manufacturing support</span></strong><span style="font-family:Calibri, sans-serif">: Provide on-floor support, troubleshooting, and deviation investigations.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-family:Calibri, sans-serif">Performance monitoring</span></strong><span style="font-family:Calibri, sans-serif">: Lead process monitoring, trending, and data analysis.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-family:Calibri, sans-serif">Validation strategies</span></strong><span style="font-family:Calibri, sans-serif">: Design and execute Stage 1–3 process validation.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-family:Calibri, sans-serif">Regulatory support</span></strong><span style="font-family:Calibri, sans-serif">: Contribute to IND/BLA/MAA filings and respond to health authority queries.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-family:Calibri, sans-serif">Statistical expertise</span></strong><span style="font-family:Calibri, sans-serif">: Apply DoE, multivariate analysis, regression modeling, and advanced statistical tools in process monitoring, troubleshooting, characterization etc.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-family:Calibri, sans-serif">Process characterization</span></strong><span style="font-family:Calibri, sans-serif">: Drive studies for design space development and CPP identification.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-family:Calibri, sans-serif">Risk management</span></strong><span style="font-family:Calibri, sans-serif">: Lead structured risk assessments (FMEA, HACCP, risk ranking) and mitigation strategies.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-family:Calibri, sans-serif">QbD principles</span></strong><span style="font-family:Calibri, sans-serif">: Define control strategies and ensure robust process design.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-family:Calibri, sans-serif">Deviation/CAPA ownership</span></strong><span style="font-family:Calibri, sans-serif">: Lead root cause investigations, CAPA, and change control.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-family:Calibri, sans-serif">Cross-functional collaboration</span></strong><span style="font-family:Calibri, sans-serif">: Interface with PD, QA, QC, Manufacturing and Regulatory teams.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-family:Calibri, sans-serif">Leadership</span></strong><span style="font-family:Calibri, sans-serif">: Act as project co-lead, accountable for timelines, deliverables, and stakeholder alignment.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-family:Calibri, sans-serif">Mentorship</span></strong><span style="font-family:Calibri, sans-serif">: Mentor junior scientists and contribute to MSAT capability development.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-family:Calibri, sans-serif">Troubleshooting</span></strong><span style="font-family:Calibri, sans-serif">: Lead resolution of tech transfer issue, complex yield, productivity, and product quality issues.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-family:Calibri, sans-serif">Optimization</span></strong><span style="font-family:Calibri, sans-serif">: Implement process improvements and cost-of-goods reduction initiatives.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-family:Calibri, sans-serif">Digital initiatives:</span></strong><span style="font-family:Calibri, sans-serif"> Drive automation, digitalization, and knowledge management in MSAT</span></li> </ul> <p style="margin:0.0cm 0.0cm 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-family:Calibri, sans-serif">Core expectations: </span></strong><span style="font-family:Calibri, sans-serif">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.</span></p> <p style="margin:0.0cm 0.0cm 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-family:Calibri, sans-serif">Syngene Values</span></strong></p> <p style="margin:0.0cm 0.0cm 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Calibri, sans-serif">All employees will consistently demonstrate alignment with our core values</span></p> <p style="margin:0.0cm 0.0cm 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-family:Calibri, sans-serif"> </span></strong></p> <ul style="margin-top:0.0cm;margin-bottom:0.0cm" type="disc"> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Calibri, sans-serif"> Excellence</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Calibri, sans-serif"> Integrity</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Calibri, sans-serif"> Professionalism</span></li> </ul> <p style="margin:0.0cm 0.0cm 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-family:Calibri, sans-serif"> </span></strong></p> <p style="margin:0.0cm 0.0cm 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-family:Calibri, sans-serif">Experience</span></strong></p> <ul style="margin-top:0.0cm;margin-bottom:0.0cm" type="disc"> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Calibri, sans-serif">Relevant practical experience in Upstream MSAT.</span></li> </ul> <p style="margin:0.0cm 0.0cm 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-family:Calibri, sans-serif">Skills and Capabilities</span></strong></p> <ul style="margin-top:0.0cm;margin-bottom:0.0cm" type="disc"> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Calibri, sans-serif">Good understanding of global regulatory guidelines (FDA, EMA, ICH) and ability to align MSAT deliverables with compliance requirements.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Calibri, sans-serif">Strong ability to co-lead projects, manage timelines, and ensure stakeholder alignment across functions.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Calibri, sans-serif">Ability to clearly articulate technical findings, author high-quality reports, and present to internal/external stakeholders.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Calibri, sans-serif">Excellent written and verbal communication skills for regulatory documentation and presentations.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Calibri, sans-serif">Openness to digitalization, automation, and continuous improvement initiatives.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Calibri, sans-serif">Flexibility to manage diverse modalities (mAbs, bispecifics, fusion proteins, microbial systems) across clinical and commercial stages.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Calibri, sans-serif">Ability to adapt schedules and priorities to meet dynamic production needs, ensuring seamless execution of technology transfer, troubleshooting, and deviation management.</span></li> </ul> <p style="margin:0.0cm 0.0cm 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-family:Calibri, sans-serif">Education </span></strong></p> <ul style="margin-top:0.0cm;margin-bottom:0.0cm" type="disc"> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Calibri, sans-serif">Master’s degree in Life Science, Chemical Engineering, Biotechnology, or related field.</span></li> </ul> <p style="margin:0.0cm 0.0cm 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-family:Calibri, sans-serif">Equal Opportunity Employer:</span></strong></p> <p style="margin:0.0cm 0.0cm 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Calibri, sans-serif">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.</span></p> <p style="margin:0.0cm 0.0cm 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"> </p>