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Project Manager - Drug Substance, Drug Product, Product Development

Company: Software Management Consultants, Inc.
Location: Thousand Oaks
Posted on: March 19, 2020

Job Description:

Job Description SMCI is seeking a Sr. Project Manager to be responsible for integrated Process Development (PD) activities by developing and maintaining technical project plans and schedules for late-stage and lifecycle projects which may include commercial PD activities, clinical manufacturing, analytical development, commercial process development, process characterization and validation, new formulations, new manufacturing processes, process and technology transfers and new or platform drug delivery devices. Working with the Global Operations Leader and other members of the Product Delivery Team, the PM develops and aligns plans and schedules for PD activities with business priorities. The PM captures associated project risks, develops mitigation plans and communicates project status clearly to impacted stakeholders. The PM assists with driving decision making for the project and ensures that action items are captured and tracked to completion. The PM partners with PD technical leads to identify key deliverables and activities to be completed, identifies dependencies, and optimizes the sequence of project activities. The PM ensures cross-functional alignment through the integration of interdependent activities and through the communication of plans and timelines, with specific emphasis on critical path activities. The PM assists PD technical leads with tracking the execution of required deliverables and assists with navigating project teams through corporate governance. The PM collects, digests and assembles information in order to enable relevant business analysis and influence decision-making. The PM will leverage soft skills, technical knowledge, and leadership attributes in order to influence positive project outcomes. Responsibilities include but are not limited to Support projects that utilize internal and external personnel, contract firms, and partners Support combination product development programs utilizing structured, systematic methodologies to meet cost and schedule objectives Develop and manage PD activities in an integrative fashion via detailed project schedules for Amgen pipeline, inline, and biosimilar projects encompassing cross-functional scope of work Partner with PD functional leads to identify key deliverables and ensure cross functional alignment and accountability Drive negotiation, decision making, and conflict resolution among teamfunctional members to accomplish project and business goals Assist the PD Organization in driving decisions by using the Decision Making Framework (D- Decision maker, A- Advice Giver, I- Informed) Establish and manage collaboration and team sites (e.g. SharePoint) Manage and prioritize support of multiple project teams at one time Provide meeting management support including meeting planning, scheduling, facilitation, documentation (development of meeting agenda and minutes), and outcomes communication Project reporting including appropriate risk analysis 20 travel domestic and international Individual from medical device or biopharma industry with medical device development or combination product experience Medical Device Development Design controls experience Planning, development, verification, launch readiness phases experienceknowledge Work experience with syringes, auto injectors, pen injectors, etc. Basic Qualifications Doctorate degree OR Master s degree and 2 years of Project Management, Process Development or Operations experience. OR Bachelor s degree and 4 years of Project Management experience OR Associate s degree and 10 years of Project Management experience OR High school diploma GED and 12 years of Project Management experience Preferred Qualifications 5 years+ of project management experience in the Pharmaceutical, Biotechnology or other Healthcare-related field, direct CMC or PD PM experience. Understanding of and experience with product development processes Ability to foster collaboration, work effectively on cross-functional teams, and consistently deliver on-time. Strong oral and written communication skills strong interpersonal skills demonstrated time management and decision-making skills. Proven ability to manage in a highly fluid, interactive, matrix environment. Required Skills DRUG SUBSTANCE DRUG PRODUCT PRODUCT DEVELOPMENT. Don't hesitate! Submit your resume today. SMCI is an EEO employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, national origin, disability, age, genetic information, marital status, military, and veteran status. Members of minority groups, Vietnam Era Veterans and individuals with mental or physical disabilities are encouraged to contact us regarding employment opportunities. In addition, in order to support the provision of business to minority-owned and Women-owned businesses (MWBE), such MWBE are encouraged to contact us regarding subcontracting business opportunities with our firm. (No third parties, please) (H1 sponsorship currently unavailable) (Local candidates only, please)

Keywords: Software Management Consultants, Inc., Thousand Oaks , Project Manager - Drug Substance, Drug Product, Product Development, Executive , Thousand Oaks, California

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