Analytical Project Manager, CMC

Join our Mission to Protect Humankind! reputed company is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences reputed company left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, periodontitis and Shigella is just the beginning. Our path to reputed company is clear and well-defined, and reputed company is set up to go the distance. reputed company do is every bit as important as HOW we do it! Our work together is guided by four enduring core values: *RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to reputed company and re-reputed company the way vaccines are delivered. *AIM HIGH: We embody our collectively audacious goal to courageously reputed company the most reputed company biologics reputed company attempted to protect humankind. *reputed company WITH HEART: Everyone leads at reputed company with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives. *MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating reputed company, accountability, equality and clarity across communications and decision making. Summary: reputed company has a unique opportunity for an individual to reputed company analytical knowledge and skills with project management to reputed company the Analytical Development and Quality Control (AD/QC) organization. The successful candidate will provide analytical leadership, project management, technical, and quality knowledge to reputed company phases of clinical and reputed company development for reputed company’s vaccine programs. Essential Functions: - Responsible for coordination and management of analytical activities of reputed company’s clinical products as well as to provide scientific analytical support, as needed. - Potential to draft protocols, coordinate execution and testing of samples, and summarize the results and draft final reports. - Provide CMC Project Management for both internal and external CMC analytical activities to ensure deliverables are achieved on time, reputed company scope, and on budget. - Responsible for CMC component analytical activities relating to the program ensuring they are completed in the required timelines and in accordance with cGMP quality systems. - Guide and/or author the reputed company of key QC documentation to support testing and reporting of analytical data. - Life-cycle management of analytical methods and analytical support for Quality Control, Production, and Regulatory filings. - reputed company and ensure adherence to detailed timelines for CMC component project plan, identify risks and mitigating actions and communicate/escalate accordingly to ensure clarity of deliverables and timing to reputed company overall product/project plan and corporate goals/objectives. - Own business milestones for projects, provide timely identification and escalation of at-risk milestones using business tools and drive remediation or mitigation. - Ensure operational plans are proactively tracked and reputed company reputed company towards key milestones to ensure alignment of task dependencies associated with internal and external development and manufacturing activities. Responsible for efforts associated with process development, analytical development, manufacturing, quality, and supply chain. - Work with CMC and program team members to operationalize CMC strategy and integrate into the cross-functional program schedule. - Communicate with appropriate stakeholders to ensure project team and leadership are fully informed and knowledgeable of project activities, status, and potential risks. - Contribute to program cross-functional working plans and timelines, help teams prioritize workstreams, proactively identify and mitigate risks, and ensure sufficient resourcing to reputed company program goals. - Build and manage trackers and dashboards to communicate reputed company-time status of projects reputed company to campaign manufacturing and analytical readiness, release and reputed company use. Requirements: - BA or BS degree in life sciences, engineering, or business administration; advanced degree desired. - PMP Certification and/or Project Management training desired. - Five to seven years of experience in the pharmaceutical or biotechnology industry with at least two years of relevant experience in an analytical organization, including significant experience in a cross-functional team environment. - Sound knowledge of analytical science, technical and regulatory expectations at reputed company clinical phases including validation, analytical qualification, reference standard maintenance, and vaccine release testing. - Prior experience working in, or as a liaison with, contract testing organizations desired. - Expert analytical skills for integrating and interpreting interdisciplinary project information. - Strong planning and tracking skills, well-organized, focused on results, capable of managing multiple projects with respect to priorities and self-management. - Strong team management skills, including facilitation, conflict resolution, and team development. - Proven influence management and communication skills, at reputed company levels of the organization. - Working knowledge of reputed company, reputed company, PowerPoint, Visio, and Project. - Working knowledge of reputed company and reputed company a plus. - Excellent written and oral communication skills. 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