Program Manager, Process Chemist-API Manufacturing

MRIGlobal Mission Hills, KS 2019-06-13
About MRIGlobal
MRIGlobal, an independent research and development organization, delivers solutions in global health, national security and defense, and energy and the environment. The organization perform scientific research, advanced engineering, and program integration and management for clients in industry, government, and academia. Established in 1944 as Midwest Research Institute, MRIGlobal is based in Kansas City, Mo., and operates in nine states and Washington, D.C. MRIGlobal employs more than 500 and manages 2,600-plus workers through management and operations programs with various clients.

Program Manager-Process Chemist-API Manufacturing – PDRM Clinical Research Support

Nature and Scope:
Program Managers provide routine technical direction to employees assigned to program and project teams. They assist senior Division staff with project expenses, on-time delivery of products, and technical quality. They share responsibility for staff project utilization.
Program Managers provide assistance in forming work teams with the required technical expertise to meet client requirements for research quality, cost control, and timeliness. Technical expertise in relevant program areas is critical. The incumbents must understand the business operations, strategic marketing goals, internal departments, and administrative systems of MRIGlobal that are necessary to support project work.
Extensive knowledge of process chemistry and scale up for GMP API Drug Manufacturing of small molecules is required. A deep understanding of analytical chemistry, separation science, and GMP regulations in the pharmaceutical industry is required.

Principal Accountabilities:Financial Accountabilities Specific to This Position:
  • Demonstrates an understanding of the nature and operation of the contract research business (i.e., project cost accounting, contract types and requirements, financial planning, and interdisciplinary applications)
  • Understands MRIGlobal's organizational structure, operations, decision-making channels, and procedures. Provides input into these systems and uses them to identify problems and recommend solutions
  • Uses business, technical, and MRIGlobal’s organizational knowledge to identify potential project, client, or technical problems. Recommends actions that may reduce the probability or impact of these potential problems
Client Accountabilities Specific to This Position:
  • Creates a good first impression. Commands attention and respect with internal and external clients based on technical experience and knowledge
  • Displays confidence in ability to apply technical knowledge and experience to solve client problems
  • Tracks project status, deliverables, scope, and schedules providing project updates, coordinating information flow between MRIGlobal and its customers
Internal Process Accountabilities Specific to This Position:
  • Lead teams of synthetic chemists to deliver on-time products within regulated specifications
  • Develop and update Standard Operating Procedures (SOP), qualification and validation protocols, master production records, cleaning protocols, etc
  • Analyzes and recommends the high-level work-breakdown structure, then integrates lower-level plans to ensure desired work will be produced on time. May establishes appropriate schedules. Estimates project cost (manpower, materials, travel, etc.) In coordination with the Contracts Department and senior staff, negotiates price and terms. Assists in monitoring progress and quality of results and establishes plans when needed. Communicates work status, concerns, and expectations about plans with task leader, MRIGlobal management, and the client, when needed
  • Reviews proposed project work to determine feasibility within proposed cost, schedule, resources, and performance constraints. Applies business judgment to technical issues. Looks at technical problems from many angles (client, business knowledge, MRIGlobal profitability and capability, environmental, societal, political, regulatory, etc.) and determines which, if any, are applicable to a client's problem
  • Assists in the review of final reports within the department to determine if quality standards have been met and client deliverables satisfied
  • Complies with all legal regulations, standards of government contracting, environmental protection, MRIGlobal policy, etc
  • Demonstrates high standards of ethical business and personal conduct through daily actions and personal example. Maintains social, ethical, and organizational norms in conducting internal and external activities
  • Participates in and conducts project review meetings for project/program or business group. Identifies critical issues in problem projects and works with Clients and Stakeholders to develop plans. Identifies projects in serious trouble and quickly brings them to a higher level of management and suggests solutions
People Accountabilities Specific to This Position:
  • Keeps abreast of current technological developments in own technical area(s) of specialization
  • Maintains effectiveness in changing environments, tasks, responsibilities, and people
  • Acts effectively when demands are ambiguous or changing, and when confronted with obstacles or adversity
  • May publish technical papers and participate in professional societies through presentations and committee participation
Success Factors:
  • Serve as Program Manager for the synthesis team to ensure project planning, executing, delivery of reports, and accurate and timely communication with Clients
  • Proficient program/project management skills
  • Demonstrated understanding of contractual and financial principles and practices needed to integrate program operations with organization and department objectives
  • Proficient oral and written communication skills
  • Proficient interpersonal skills
  • Experience with Microsoft Office 365, Outlook, and SharePoint a plus
  • Excellent customer service, communication, and presentation skills
  • Leads meetings (internal, external, and joint) including scheduling, preparing agendas, collecting and issuing minutes, defining and tracking actions, etc
  • Ensure all documentation produced complies with cGMP standards
  • Responsible for contributing to audit readiness and for participating in quality audits with FDA, other Regulatory Agencies, and customers, as needed
  • Ensure work complies with all state and federal regulations, including but not limited to GMP, DEA, FDA, etc
Minimum Qualifications:
  • Ph.D., M.S./M.A. in Chemistry, and a minimum 3 years of related experience; B.S./B.A. in Chemistry, minimum 6 years of related experience; or appropriate combination of education and experience
  • Demonstrated experience in GMP API Drug Manufacturing of small molecules
  • Experience in process chemistry; optimizing reactions in multi-step schemes; scale-up development (1 to 5 kg)
  • Leading teams of synthetic chemists to deliver on time products within specifications
  • Complete understanding of all phases of pre-Clinical and Phase I/II Clinical Drug Substance/Product Manufacturing from process R&D through delivery of GMP product
  • Demonstrated experience and ability to provide contract deliverables, including completed batch records, manufacturing campaign summaries, and monthly progress reports
  • Experience delivering reports in sufficient detail for regulatory FDA submissions
  • Serve as Program Manager for the synthesis team to ensure project planning, executing, delivery of reports, and accurate and timely communication with the Client
  • Developing and updating Standard Operating Procedures (SOP), qualification and validation protocols, master production records, cleaning protocols, etc
  • Project Management Professional (PMP) certification and familiarity with project management software is highly desirable
It is the policy of MRIGlobal to provide equal employment opportunities (EEO) to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status or any other applicable federal or state protected classification.
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