Direct and provide technical and scientific oversight of the actions of several groups responsible for the preparation and review of complex scientific and regulatory documentation supporting new drug applications, product launches, and technical investigations and modifications of existing formulations and processes. Oversee the execution and documentation of technical investigations. Prepare process validation protocols and reports according to current regulatory standards.
Prepare, manage, and change control documentation associated with GMP batch manufacturing. Perform job functions in accordance with all applicable Standard Operating Procedures (SOP), federal and state laws, Occupational Safety and Health Administration (OSHA) guidelines, health authority regulations, and departmental processes. Direct, provide technical oversight, and ensure timely preparation and review of complex scientific and regulatory documentation supporting new drug applications, product launches, and technical investigations & modifications of existing formulations and processes. Keep current with regulatory guidelines, compendial requirements, technical innovations, and topics of current interest regarding formulation, process control and improvement and validation. Establish robust systems for conducting and reporting technical investigations to ensure: timely and effective root cause analysis of the problem at hand; timely and effective identification and implementation of preventative and corrective action; and clear and concise documentation of the investigation and resolution. Connect, Collaborate and Communicate with Global R&D, and launch management and execution teams to ensure timely completion of investigations and documentation associated with scale-up, launch, submission, or commercial manufacturing objectives. Work with Quality and Manufacturing personnel to ensure smooth and timely transitions of all FDA approved documentation in to controlled Manufacturing files. Collaborate with the R&D, Manufacturing, and Tech Services teams to identify Critical Process Parameters, Critical Material Quality Attributes, Critical Quality Attributes, Control Strategies, and Sampling and Testing Plans included within process optimization or validation protocols. Oversee the preparation, review and approval of validation protocols and reports, manufacturing batch records, change controls, and any other documentation associated with process optimization, new product introduction or commercial manufacturing activities. Serve as a scientific and technical resource and mentor in educating and training local tech services and manufacturing personnel in good documentation practices and current concepts regarding continuous process validation. Assist scientific and technical personnel in designing and writing process optimization and validation protocols. Review and approve exhibit batch manufacturing investigations, reports, and technical documentation related to process design and optimization and exhibit batch execution and submission.
Qualifications
Mylan hires only the best. People who thrive in a culture of innovation and empowerment. People who are active learners and have a positive attitude. People who are leaders and know that by working together we can run faster, reach higher and achieve more. By doing so, we will continue to set new standards in health care. Here are the minimum qualifications and essential functions for this position:
Bachelor’s degree or equivalent in Pharmaceutics, Chemistry, Engineering (any type), Manufacturing, or a related field, and 5 years of experience in position offered or related, including 5 years of experience with: Generic Product Development, including Solid Oral Dosage Form Formulation and Process Development; Manufacturing processes and procedures utilized in the manufacture of solid oral dosage forms, including wet and dry granulation, modified release coated beads, direct compression, and coating; Solving complex technical problems related to manufacturing processes, in particular problems related to in-process or finished dosage form analytical and/or processing performance; Conducting and documenting effective root cause analysis with respect to product performance issues; identification, implementation, and closure of effective CAPAs related to same; All stages of project management related to product technical transfers including planning, project initiation, execution of analytical and manufacturing transfer activities between the donor and receiving sites, tracking of all activities, and identification and resolution of issues and bottlenecks; All stages of project management related to qualification of alternate source materials including planning, project initiation, execution of risk analysis and manufacturing activities required to meet requirements of subsequent regulatory agency notifications/submissions.
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