Principal Scientist-Molecular Assay Development

JOB DESCRIPTION Designation: Principal Scientist Job Location: Bangalore Department: TRANSLATIONAL MEDICINE About Syngene Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene’ s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation. Job Purpose A hands-on laboratory scientist responsible for delivering high quality, compliant genomic data in support of clinical programs. The individual drives robust assay development, qualification and sample analysis while providing consultative subject matter expertise to matrix teams and collaborating cross-functionally to enable timely, data-driven decisions. The role may additionally involve providing scientific guidance to the team members, depending on organizational need. Key Responsibilities: The individual is expected to lead a small team, work on design of experiments and help in implementing the strategy for optimizing the current assays and onboarding new technologies. The individual will work to optimize, validate and carry out genomics/transcriptomics assays for programs with stakeholders, collaborate for data analysis. Developing expertise and achieving qualifications to perform qPCR- and NGS-based assay for gene expression and genotyping. Assay design and development: Participate in the efforts to develop the framework for assay development, qualification/validation and timely, well-planned execution of assays and clinical sample analysis working with cross-functional teams. Help troubleshoot assay platform, assay performance. As an individual contributor, responsibilities will also include: Design experimental plans, validation reports, work instructions, technology transfer documents, study summaries and SOPs. Providing subject matter expertise to stakeholders as required. Accurate record keeping of experiments and procedures Create and review GCP documents Involve in lab operations Work closely with data analysis teams as well as sample management and clinical operation teams on programs. Involve in other lab related activities. Educational Qualification (Indicate minimum qualifications required specific to the role. Indicate mandatory and optional qualifications) Educational Qualification: • in Biotechnology, Molecular Biology or Life Sciences Technical Skills: Significant demonstrable experience and subject matter expertise in NGS-based genotyping or GEP applications. Genomics experience in any of disease areas that include cardiovascular, immunology, oncology and other disease areas Expertise, in-depth hands-on experience is expected in genomics platforms (NGS, qPCR, variant analysis platforms) for assay development, qualification/validation, troubleshooting, and reviewing run QC data. Experience with additional technologies leveraged for ctDNA analysis and GEP analysis would be desirable. Hands on experience in handling various sample types such as FFPE, Blood and Saliva Expertise, in-depth hands on experience is expected in performing NGS assays such as RNA-seq, WES, WGS ; and qPCR based assays for GEP and genotyping. The candidate must demonstrate significant work experience in clinical assay development for genomics assets preferably in a pharma, biotech or clinical lab setting. Understanding of fit for purpose genomics assay qualification principles for clinical assays. Familiarity with genomics assay validation guidelines and guidance in a regulatory framework ( GCP or global regulatory requirements for assay development) & basic understanding of IVD quality system standards (21 CFR part 820, ISO13485) would be a plus Thrive in a highly interactive, fast paced and dynamic team environment with agility and rigor. Behavioral Skills: Strong problem-solving and collaboration skills, and rigorous and creative thinking Excellent written and oral communication skills, including an ability to discuss and explain complex problems The ability to work across organizations to define and solve problems will benefit the whole. Capable of establishing strong working relationships across the organization. Communicate effectively to build support for work and align with organization Experience: • . with 10 plus years of relevant experience 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.