Seeking 5+ years experience in Antigens, Monoclonal Antibodies or related biopharmaceutical products; solid knowledge of ISO 13485 standards, GMP regulations 21 CFR Parts 210, 211 and 820; track record implementating and managing quality systems within a development and contract manufacturing organization; and skills in risk management, tolerance studies, product reliability and safety assessments
Design FMEA, DOE, gauge R&R, SPC, GMP, QSR, design verification, process validation, regulatory audits ...
Primary Function / Primary Goals / Objectives:
Leads and directs all marketing activities for the assigned product line(s) or business. Responsible for the development, management, and execution of strategies and tactical programs to effectively achieve commercialization, profit margin and business plan objectives. Directs and supervises a staff including two or more Marketing Professionals. Additional responsibilities include business strategic planning, concept evaluation forecasting, financial ...
Direct quality assurance activities and quality oversight of cGMP and GMP functions for pharma biologics manufacturing operation with division of global company.
*** Develop and implement strategy, policy and group objectives.
*** Interact with regulators, internal staff and industry experts.
*** Interpret regulations.
*** Manage budget, schedules, staff and other resources.
*** Improve employee productivity -- coach, mentor and develop professional staff.
*** Analyze, assess, manage, ...
Jan 21 -
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