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Job Description & How to Apply Below
Designation: Senior Research Investigator
Job Location:
Bangalore
Department: TRANSLATIONAL MEDICINE - GENOMICS
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:
Leads a small team to deliver high quality, compliant genomic data in support clinical programs. The role ensures robust assay development, qualification, sample analysis, consultative SME support in matrix teams and effective cross functional collaboration to enable timely, data driven decisions.
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.
Strong experience with NGS workflows is a plus
The individual will work to optimize, validate and carry out various genomics/transcriptomics assays for programs with stakeholders, collaborate for data analysis.
Developing expertise and achieving qualification to perform qPCR- and NGS-based assays 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 analysis working with cross-functional teams.
Help troubleshoot assay platform, assay performance to ensure the generation of reliable and quality data to support exploratory biomarker research.
As an individual contributor, responsibilities will also include perform assay development, qualification and clinical sample analysis in compliant manner
Design experimental plans, write assay qualification 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 (ELN and LIMS) as per established GCP guidelines
Work closely with data analysis teams as well as sample management and clinical operation teams on programs.
Technical
Skills:
Significant demonstrable experience and subject matter expertise in genotyping or GEP applications
The candidate must demonstrate significant work experience in clinical assay development for genomics assets preferably in a pharma, biotech or clinical lab setting.
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.
Bioinformatics experience would be a plus
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, ISO
13485) would be a plus
Expertise in serving as subject matter expert on technology specific data structure, data analysis, data QC in working with data analysis team.
Must have strong organizational and collaborative skills.
Thrive in a highly interactive, fast-paced and dynamic team environment with agility and rigor.
Educational
Qualification:
• Ph.D.
Experience:
• PhD with 2 – 4 Years or M.Sc. with 10 plus years of relevant experience
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
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
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.
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