Are you a recently certified Project Management Professional or in the middle of taking Project Management courses? Do you have experience managing projects in Product Development in a Biotech or Pharmaceutical Company? Do you specifically have an understanding of GLP and GMP standards? Then we are interested in learning more about YOU!
Come join the SeraCare team and you will be provided with challenging and satisfying work, opportunities for individual growth and career development and recognition and reward for a job well done.
SeraCare Life Sciences is seeking a qualified individual for the position of Project Manager, Product Development. In this position you will manage specific Product Development projects through all stages from concept through commercialization and post market launch. Your major responsibilities will include creating product development timelines and budgets, delegating responsibilities within the product development process and managing and documenting phase reviews. You will be responsible for the management of at least two large projects and multiple smaller projects in the Product Development department. Importantly you will be responsible for successfully influencing and coordinating interactions with personnel in a variety of disciplines across multiple product launches and across multiple corporate locations.
Projects you will be involved with will include new product development and internal and external OEM products with responsibilities in planning the work and/or objectives; planning detailed project budgets; analysis and design of objectives; assessing and mitigating risk; estimating resources; organizing the work; managing project execution; building the Design History Files, tracking and reporting team progress; analyzing the team performance based on project data; and periodic reporting of metrics to Executive Management. Periodic travel will be required. You must have at least two at least two years experience in Project Management in the biotechnology or pharmaceutical industry. You must have demonstrated success in project management as well as a solid understanding of current GMP and GLP standards. You must be recognized as having excellent communication, interpersonal, organizational and multi-tasking skills. Proficiency in maximizing the use of computers and available software to leverage your capabilities is a must. You must have strong skills in Microsoft Office, Project and Visio. This position requires excellent use of judgment and discretion required. PMP certification is preferred. Candidates familiar with 21 CFR part 820.30 and ISO 13845 will be given special consideration. BS/BA in biological science or engineering preferred. Experience in writing and executing process; product and performance validations are a plus as is experience in coordinating product design input specifications in conjunction with R&D and Marketing. The successful candidates will demonstrate the ability to communicate with personnel across disparate technical and business backgrounds such as R&D, Marketing, Sales, Manufacturing, Executive Management, Quality Assurance and Regulatory Affairs.
SeraCare Life Sciences, Inc. is an Equal Opportunity Employer, M/F/D/V