Enzene Biosciences
Website:
enzene.com
Job details:
Roles & Responsibilities:
Plan and oversee method development, method qualification, and method transfer activities for plate-based assays.
Prepare and review critical documents such as Method of Analysis (MOA), Method Qualification Report (MQR), and Method Transfer Protocol (MTP).
Review data for drug substance (DS) and drug product (DP) release analysis and communicate results effectively with stakeholders.
Perform in-house calibration and verification of laboratory instruments and equipment.
Provide guidance and training to team members ranging from TRA to Senior Scientists.
Plan daily activities, present data to cross-functional teams in internal meetings, and prepare responses to queries.
Experience & Qualifications:
Qualification: M.E/M.Tech/MS, M.Sc/Ph.D in relevant fields.
Technical Skills Required:
Expertise in planning and troubleshooting analytical method development, method qualification, and method transfer activities.
Proficiency in conducting biosimilarity and characterization studies.
Soft Skills Required:
Adaptability and teamwork.
Strong communication and presentation skills.
Ability to collaborate effectively with multidisciplinary teams to support R&D projects and product development.
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