CMC Project Manager with CMC, Biologics/Synthetics
Project Manager Senior with CMC, Biologics/Synthetics, Project Manager and Pharma/Biotech Industry Experience (Fully Remote Job) Location: Thousand Oaks, CA Terms: Contract W2 Duration : 12 Months Contract (Will Get Extended for Long) Description: Fully Remote, flexible to work in any time zones Client is searching for a Sr. Project Manager in our CMC Integration team within Operation Products Advancement in Process Development. This role will be based on our main corporate campus in Thousand Oaks, CA. This Sr. Project Manager will have the focus on supporting programs in the Pivotal, Life Cycle Management and Commercial space working with the Operations Leader and the Product Delivery Team. The Sr. PM will manage cross-functional teams within Process Development (PD) across all modalities (Biologics and Synthetics) as needed. They will partner with technical leads to identify key deliverables, ensure cross functional alignment, and execute plans. They are expected to proactively manage plans to meet deliverables with their teams. Partnering with key Product Delivery Team stakeholders, the Sr PM will need to understand the Clinical Development Plan and strategy to enable alignment with tox, clinical and commercial targets The Sr PM will draft timeline scenarios to enable/adjust project execution across multiple development paradigms to inform portfolio decisions Ensure teams active, aligned communication in functional and cross-functional management reviews and governance meetings Leverage soft skills, technical knowledge, and leadership attributes to influence positive project outcomes. Assist PD in driving decision making and communication Establish and manage collaboration and team sites. Track delivery and create repositories for all Process Development deliverables Project reporting including appropriate risk analysis Partner with Business Analysis and Performance to report product metrics Facilitate and incorporate lessons learned, and best practices Support Business Process improvements, including alignment with the Commercialization Office Basic Qualifications: Doctorate degree and 2 years of Project Management experience in Pharmaceutical Product Development OR Master’s degree and 6 years of Project Management experience in Pharmaceutical Product Development OR Bachelor’s degree and 8 years of Project Management experience in Pharmaceutical Product Development Preferred Qualifications: Master’s degree with 6 years of projects management experience, OR Bachelor’s degree with 8 years of project management experience. Minimum of 10 years of experience in the Pharmaceutical, Biotechnology or other Healthcare related field, direct CMC experience is highly desirable Ability to foster collaboration and work effectively on cross-functional teams Strong interpersonal and communication skills with the ability to effectively interface across all levels of the organization Critical thinking and problem-solving skills Apply standard Project Management tools, and practices; experience with MS Project, Planisware, PowerPoint, Excel, MS Teams and SharePoint highly desirable Skill Sets: Six to ten years of project management experience Degree in science (Biological sciences, chemical engineering, pharma) Biotech/Pharma industry experience