Manufacturing Analytical Ability Quality Assurance Leadership Ability Communicatio   Requirement id 99740 Job title Manager Job location in Philadelphia, PA Skills required CMC Experience, Operations Management, Project Experience, Manufacturing Analytical Ability Quality Open Date 31-Oct-2019 Close Date Job type Contract Duration 6 Months Compensation DOE Status requirement --- Job interview type ---    Email Recruiter: coolsoft Job Description Manager: CMC Experience, Operations Management, Project Experience, Manufacturing Analytical Ability Quality client info: Genpac Responsibilities Operations/Project Management - Technical Project Manager III Base Location – Near Philly Zipcode 19446 Pennsylvania Bill Rate: $80 Hourly Count of Resource: 6 Duration: 6 Months Must haves: CMC experience :CMC 3, 7 years. Description of Role and Responsibilities "Essential function(s) includes, but is not limited to: Reporting to the Director, the Associate Director is responsible for developing and implementing CMC (chemical and pharmaceutical manufacturing and control) regulatory strategies for assigned pharmaceutical products in accordance with global regulations and guidances, and Merck procedures. The Associate Director will lead the preparation and submission of CMC dossiers for life-cycle changes to commercial products. The Associate Director may manage a team of 2 to 4 individual contributors in support of project execution. • Serve as the CMC Product Lead for assigned products and be accountable for the delivery of all regulatory milestones for assigned products through the product lifecycle. • Lead development and execution of global product and project regulatory strategy(ies) by ensuring robust assessment of CMC changes, identification of global regulatory requirements and critical evaluation of supporting documentation to confirm acceptability and identification of potential risks. • Execute regulatory strategies by leading the development, authoring and review of CMC submission components and documentation to support post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems. • Provide regulatory leadership as needed to product in-license/due diligence review, product divestment and product withdrawal. • Collaborate with MMD and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance. • Manage execution of CMC documentation including post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems. • Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure approval and Product supply continuity. • Assess and communicate potential regulatory risks and propose mitigation strategies. • Deliver all regulatory milestones for assigned products across the product lifecycle • Identify, communicate and escalate potential regulatory issues to GRACS CMC management, as needed" Required Qualifications "• Strong experience in CMC requirements for small molecule/biologic products. • Proven experience in critically reviewing detailed scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data. • Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner. Strong listening skills. • Demonstrated sound understanding of related fields (e.g., manufacturing, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving. • Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders. • Demonstrated flexibility in responding to changing priorities or dealing with unexpected events. • Demonstrated effective leadership, communication, interpersonal and negotiating skills. • Ability to lead a   Call 502-379-4456 Ext 100 for more details. Please provide Requirement id: 99740 while calling.   Other jobs in PA: Dauphin (1), Dauphin County (3), Downingtown (2), Glen Milla (1), Harribsurg (1), Harrisburg (47), Horsham (6), Malvern (2), Pennsylvania (13), Phila (2), Philadelphia (16), Pittsburgh (1), Radnor (2), Reading (1), Sharon (3), WAYNE (1), West Cheste (1), West Chester (33),         (Manager: CMC Experience, Operations Management, Project Experience, Manufacturing Analytical Ability Quality in Philadelphia, PA)

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