Project Manager, Change Control (Contract) 665
$120,640–$135,200 year
On-siteBoston, Massachusetts, United States
Boston, Massachusetts, United StatesOn-siteFull Time$120,640–$135,200 yearBachelors DegreeLarge
Full TimeBachelors DegreeLarge
Job Summary
Partner closely with functional area leads to maintain integrated project plans and identify critical path activities for cell and gene therapy T1D change controls. Track key milestones, communicate status and risks to stakeholders, and drive the completion of changes while organizing team communications and risk analyses. Develop project management tools and templates to manage team activities, consistently performing duties within established SOPs and GxP requirements. Work effectively in cross-functional, matrixed teams to prioritize competing priorities and deliver project success.
Required Qualifications
- detail-driven
- proven history in managing and driving project success within the biotech industry
- strong technical background
- solid working knowledge of GMPs
- understanding of the drug development pathway through commercialization
- willingness to pivot as priorities change
- excellent communication skills, written and verbal
- high attention to detail
- ability to work effectively in cross-functional, matrixed teams
- Bachelor's degree in engineering, life sciences or related field
- minimum of 8 years of experience in the biopharmaceutical industry
- minimum of 6 years of experience in project management of biopharmaceutical product
- Working knowledge of biotechnology, GMPs, and drug development lifecycle
- Ability to work effectively in cross-functional, matrixed environment, prioritizing and managing multiple tasks simultaneously, integrating cross-functional issues and balancing competing priorities effectively
- Expertise in Microsoft suite (Project, PowerPoint, SharePoint, Word, Excel, Outlook)
- Excellent oral and written communication skills, including presentation and facilitation skills, to effectively inform key updates & issues across all levels of the organization
- Strong analytical, problem solving and critical thinking skills, including an ability to combine attention to detail with a big picture perspective
- Strong understanding of regulatory requirements (FDA, 21 CFR Part 211, EU GMP, ICH Q10)
Desired Qualifications
- Knowledge and/or experience with cell / gene therapy methodologies
- strong understanding of risk management
- Experience with other PM tools a plus (e.g., Smartsheet, Power BI, etc.)
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.