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Friday, January 27, 2012

Senior Manager - Technical Development, 5-10 years exp, Hyderabad / Secunderabad


The incumbent is expected to play multi-functional role in terms of supporting the reporting manager in coordinating and monitoring external research efforts as well as in-house capacity building efforts. He / she will work in close collaboration with facility design consultants, clinical development, regulatory affairs, R&D teams, and external operational contractors
Requisite candidate profile:
• Approximately 5 years of hands-on experience in analytical method development, quality control and quality systems aspects of biopharmaceutical research

• Sound knowledge of monoclonal antibody-related research and analytical techniques with special reference to assay development will be considered a strong advantage

• Exposure to global CMC related fields and biopharmaceutical development

• Relevant experience in providing QC support during GMP transition of lab-scale processes

• Ability to function independently

Salary: As per industry norms
Industry: Pharma, Biotechnology, Clinical Research
Functional Area: Healthcare, Medical, R&D
Role Category: R&D
Role: Bio/Pharma Informatics-Associate/Scientist
Keyskills: analytical research, therapeutic proteins, quality assurance / testing, biotechnology, biopharmaceuticals, biologics, chemistry manufacturing control, cGMP,recombinant protein expression technologies, monoclonal antibody,technology transfer,
Desired Candidate Profile
Education: (UG - B.Pharma - Pharmacy, B.Sc - Bio-Chemistry, Biology, Chemistry, Microbiology, B.Tech/B.E.) AND (PG - M.Pharma, M.Tech - Bio-Chemistry/Bio-Technology, Biomedical, M.Sc - Bio-Chemistry, Biology, Microbiology) 

Essential duties & Work Environment:
• Definition of product specifications based on pharmacopoeia monographs or reference medicinal product disclosures 

• Design & implementation of adequate in-process quality control measures based on physico-chemical, biochemical or functional methodologies that will facilitate accurate quantification and qualification of the product during production, recovery, storage in bulk and in formulated states

• Design & establishment of rationale-based, product-specific in vitro bioassay procedures including cell-based analyses & ELISA 

• Design and ensure implementation of strategies to minimize bio-burden

• Design & development of procedures to clearly demonstrate and distinguish product-related and product-unrelated impurity profile

• Proper daily / weekly / 90-day planning and execution of GLP-compliant experimental procedures so that the projected targets are achieved

• Review of experimental batch records

• Review of SOPs for regulatory compliance and effectiveness

• To ensure proper utilization and productivity of Manpower and Machines.

• To ensure all records / documents are maintained in compliance to regulatory requirements. 

• Impart necessary training to group members

Company Profile
Mylan Pharmaceuticals Pvt.Ltd ( A Mylan Inc. Company ) 
http://www.mylan.com 
Mylan is one of the world’s leading generics and specialty pharmaceutical companies, providing products to customers in more than 150 countries and territories. The company maintains one of the industry’s broadest and highest quality product portfolios, which is regularly bolstered by an innovative and robust product pipeline. With a workforce of more than 18,000, Mylan has attained leading positions in key international markets through its wide array of dosage forms and delivery systems, significant manufacturing capacity, global commercial scale and a committed focus on quality and customer service. The company ranks among the top five generics companies in several markets around the world and is the largest U.S.-based generics manufacturer in the world. 
View Contact Details
Contact DetailsExecutive Name:Vinod Gopishetty
Contact Company:Matrix Laboratories Limited
Address:House No 8-2-293/82/J - III, Plot No 564/A/22, Road No 92 Jubilee Hills HYDERABAD,Andhra Pradesh,India 500033
Email Address:vinod.gopishetty@mylan.in
Telephone:91-40-30866057

Reference Id:BIOLOGICS-TECHNICAL DEVELOPMENT
  • Position:
    Manager
  • Job Location:
    Pharmaceuticals Pvt.Ltd ( A Mylan Inc. Company ) in Hyderabad / Secunderabad, India

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