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. Through its India-based subsidiary Mylan Laboratories Limited, Mylan has direct access to one of the world's largest active pharmaceutical ingredient (API) manufacturers. This relationship makes Mylan one of only two global generics companies with a comprehensive, vertically integrated supply chain. Mylan Laboratories Limited also is one of the world's largest producers of API used to make generic antiretroviral (ARV) therapies for the treatment of HIV/AIDS.
Name of the Post: Manager / Sr.manager - Analytics ( Physicochemical Assays )
Experience: Minimum 6 to 8 years
Position Purpose :
A brief summary of the purpose this position must fulfill.
The incumbent will be responsible for defining and managing the analytical development, method transfer and quality control functions in support of in-process, release and stability testing of drug substance and drug product for early-stage biopharmaceutical development programs
will provide oversight and participate in the management and monitoring of cGMP-compliant contracted manufacturing and product and stability testing activities
and will work with quality assurance, compliance and regulatory functions to meet project demands and contribute to submissions to regulatory authorities.
Essential Duties and Responsibilities :
Supervise and guide development/optimization of analytical methods for testing and characterization of biopharmaceutical products, including LC-MS, HPLC, CE and electrophoretic methods and methods related to drug product safety.
Collaborate guide and influence assay development team members (internal and CRO/CMO-based) during development of new methods, method optimization and feasibility studies.
Manage method transfer and preparation and approval of SOPs, validation protocols and method validation reports; review and revise SOP's; review and contribute to regulatory filings.
Monitor analytical deviations/OOSs, lead laboratory investigations and participate in manufacturing-related investigations. Proactively incorporate learnings to improve and influence method development and optimization.
Perform on-site representation (person-in-the-plant) during testing of drug substance/product.
Manage and guide drug substance/product stability programs and drug product expiration/retest date notifications.
Where appropriate, serving as primary contact with CROs/CMOs responsible for in-process, release and stability testing in support of manufacturing development, production, preclinical and clinical activity.
Expected to participate in the management and control of document/records for GMP and GLP operations
Experience in validation and transfer of methods used for characterization of biological products
Experience in handling LC-MS, MS-MS, MALDI-TOF etc. is desirable
Experience in validation and transfer of methods used for characterization of biological products
Working knowledge of current Good Manufacturing Practices (cGMPs) for the US and EU, Good Laboratory Practices (GLPs), and ICH guidelines as they relate to testing and characterization efforts for late phase clinical and commercial drug supply and/or biopharmaceutical production
Knowledge :
Thorough knowledge of Biochemistry, bioassay and associated instrumentation; knowledge of protein stability assessment
Experience in validation and transfer of methods used for characterization of biological products
Experience in handling LC-MS, MS-MS, MALDI-TOF etc. is desirable
Experience in validation and transfer of methods used for characterization of biological products
Working knowledge of current Good Manufacturing Practices (cGMPs) for the US and EU, Good Laboratory Practices (GLPs), and ICH guidelines as they relate to testing and characterization efforts for late phase clinical and commercial drug supply and/or biopharmaceutical production
Ability to prioritize and successfully manage complex and competing projects
Excellent communication and organizational skills
Ability to proactively mitigate quality/regulatory risks
Motivated team player with proven leadership abilities
Supervision:
Position directly supervises employees. Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities may include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
Education and Experience:
Masters or PhD degree in Biochemistry, Cell Biology, Analytical Chemistry or related scientific/technical background
A minimum of 6-8 years of experience in the Biotechnology/pharmaceutical industry, including a minimum of 2-4 years experience involving quality control laboratories in a facility making biopharmaceutical drug substance and/or drug product for US and/or EU studies. Must have at least 2 years supervisory or managerial experience
Language Skills:
Ability to read and interpret comprehensive and intricate research documents. Ability to write scientific reports and technical correspondence. Ability to work with executives and communicate abstract concepts. Ability to present to a high level of the organization and groups outside of the organization.
Interested Candidates can Email their to Resume to Vinod Gopishetty ( vinod.gopishetty@mylan.in)
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