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Director - Biologics

Secunderabad, Telangana
Job Code:
  • Biotechnology & Science
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Job Details

ResponsibilitesResponsible to ensure that lab adheres to USPs mission, goals and objectivesAssists in the USP-NF activities for General Chapters, Monographs and Reference Standard development in the area of Proteins, Peptides, and Complex BiologicsProposes annual budgets, projects resources, capital and personnel needs for the India-Biologics LabParticipates in USP cross-functional teams as appropriateParticipates in Global USP teams as appropriateDirects and Conduct s different collaborative projects, training projects at India lab in bioanalytical, bioassay and microbiology relevant to public standards in the areas of Proteins, Peptides, and Complex BiologicsReviews data and edits reports from India-Biologics LabResponsible for review and implementation of SOPs, Protocols, etc.Assist VP & Global head in integration of global Biol LabsAssists VP in planning, implementing and evaluating laboratory procedures/systemsAssists VP in expansion plan with proper recommendationsSupervises staff as assigned. Performs supervisory duties such as performance reviews, objective setting, staff development and career counselingAssists in the development and implementation of safety projects impacting India-Biologics Lab personnelSupports and helps improve the USP-India Quality Management SystemsDemonstrates a strong desire to continue learning and grow personal capabilityPursues, recommends and implements new approaches or processes to improve Group s operationsPerforms other duties as assignedRequired SkillsA comprehensive understanding of the science involved in the development of biopharmaceutical standards and reference materials is required.A basic understanding of the processes of the USP is desired.Demonstrate a deep knowledge and strong skills in the areas of physicochemical analysis, bioassay for the biological medicines and microbiology.Laboratory experience must include method development and validation - chromatography-based techniques, electrophoresis, colorimetric assays, mass spectrometry, immunological methods.Experience in the organization and facilitation of collaborative studies is desirable.Excellent technical writing and verbal communication skills in English are required. Good interpersonal skills and proven ability to function in a team-oriented environment are necessary. A proven leadership and staff management skill is a must.Required ExperiencePh.D. in biology or related fields with laboratory and industry experience no less than 15 years in the areas of biological product research and development.The candidate should have comprehensive experience on analytical methods for the various biological products such as peptides, proteins, carbohydrates, and other macromolecules in addition to knowledge on quality management system and basic regulatory filing requirements.Management experience with a group of scientists and good communication skills with multiple disciplines are essential. Excellent communication in English is a must.
Degree: Ph.D. (Doctorate)

Additional Degree: B.Pharm. (Pharmacy)

Experience: 15-20


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