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Assistant General Manager (Regulated Bioanalytical Large Molecule)-

12.00 to 15.00 Years   Chennai   10 Dec, 2022
Job LocationChennai
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaSales / BD
EmploymentTypeFull-time

Job Description

    Job PurposeLeading a regulated large molecule bioanalytical team Will be responsible for the overall performance of the laboratory including assay compliance, client deliverables, scientific output, innovation, people, P&L and client relationships Will be responsible for providing tactical solutions and scientific oversight to all projects running in the laboratoryKey Responsibilities: Leading a regulated large molecule bioanalytical team o Will be responsible for the overall performance of the laboratory including assay compliance, client deliverables, scientific output, innovation, people, P&L and client relationships o Will be responsible for providing regulatory guidance based scientific solutions and oversight to all projects running in the laboratory o Will be required to bring new technologies and modalities into the bioanalytical area; as required o Will play a central role in laboratory building as per organization goals o Job requires to be working with a collaborative large molecule bioanalytical team on analytical immunoassay and cell-based methods for Pharmacokinetic, Immunogenicity, Pharmacodynamics and Biomarkers for biologics, vaccine and CGT o Responsible for overseeing technical and regulatory (GLP & GCLP) compliance of programs o Role requires to be point of contact for regulators o Role will need routine reviews of method development, transfer, validation and sample analysis data and reports o Responsible for performance management and assessment of reporting staff o Will be required work independently as well as in teams to make technical reviews of data, analysis of data and aid in data interpretation o Will be required to work in a collaborative model with various functions within the laboratory as well as departments within Syngene- BD, Quality, Logistics, etc. o Will require frequent interactions with Indian and international clients on overall health of collaboration as well as project specific scientific pointsEducational Qualification: PHDTechnical/functional Skills: PhD in Biochemistry/ Microbiology/ other biological sciences with an experience of 15-20 years with a strong biotech and analytical track record Should come with operational planning experience for project execution of various complexities in the large molecule bioanalytical area Experience in use of molecular biology to support bioanalysis of gene therapy products is a plus Experience with financial forecasts, multi-year plans, management of large teams and strategy development is a must Experience with working for a large molecule bioanalytical CRO lab will be a plus pointExperience: 12-15 YearsBehavioral Skills: Role requires an extremely bright, dynamic experienced professional with leadership qualities with a strong commitment to compliance, integrity and patient safety Must be willing to work hands on large molecule bioanalytical projects Should have the urge to gain and share knowledge through publications and presentations Should be able to build and manage multi-level and multi-skilled teams Excellent written and verbal communication skills, including scientific writing Must maintain a culture of inclusiveness and integrity,

Keyskills :
business developmentmanagementsalestargetmarketing

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