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Project Coordinator

San Mateo Metro Area, CA

Posted: 07/25/2019 Job Type: Scientific Job Number: JN -072019-25274

The candidate who fills this position will be expected to support project and resource planning as it relates to timelines, equipment and manufacturing scheduling, supply chain, RBUs, and capacity extrapolations for R&D Feasibility through late stage clinical and technology transfer projects..

RESPONSIBILITIES:

In conjunction with project leader and project manager, support several new chemical entities (NCEs) through the development process of feasibility through early clinical phase development/production

In conjunction with functional lead, manage production schedules, equipment and resources as they pertain to production demands and forecasting

Support collaborations with external research organizations

Support with implementation of lean practices

Support project timelines, budgets, and resource needs for each NCE, working collaboratively with scientific leaders

Responsible for preparing and maintaining project schedules and activity trackers to ensure timelines are met

Support the financial aspects of the projects (i.e., creating and managing budgets, setting up vendor contracts and Purchase Orders, tracking invoices, and accruals)

Support in managing team meetings (agendas, action items, status reports)

REQUIREMENTS:

BA/BS Degree in a relevant science discipline; a higher degree preferred with 2-3 years of experience in drug development within the pharmaceutical industry.

CMC design, development and technical support experience from phase I to late stage

development and/or post launch phases

Preferable inhalation product development, clinical/commercial supply chain, regulatory experience with ideally good knowledge of the broader business especially development, commercialization, post-launch technical support and lifecycle management

Experience of cost management (FTEs and $)

Demonstrated strong interpersonal and communication skills (credible and persuasive)

Proactive, forward-thinking and creative with high ethical standards and a team player with leadership skills and ability to influence others to achieve successful outcomes and meet timelines

Familiarity with domestic and international cGMP regulations and industrial guidance documents (CFRs, ICH)

Self-motivated and willing to accept responsibilities outside of initial job description

Experience in developing and maintaining program timelines through project management software, Gantt charts, participating and writing meeting minutes of program team communications for record keeping purposes

Ability to handle multiple project and priorities with exceptional organizational, attention to detail and time management skills

Experience with Lean is a nice to have

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