- Managing development and manufacturing program schedules to ensure new projects are kicked off according to schedule, in-progress activities are completed on time, and deliverables are sufficiently high quality.
- Supporting the CAMRIS Vice President of Programs in the development and execution of program plans, PBF operational strategies, and management plans.
- Implementation and continuous improvement of manufacturing of PBF Manufacturing procedures, policies, and systems in alignment with or exceeding industry standards.
- Daily alignment with other PBF Sr. Management peers and fostering of a cohesive and productive leadership team at PBF.
- Coordination with the BD Manager, BPD Manager, VDAD Manager, Quality Lead, Operations Manager, and PBF Director on all PBF business transactions and in alignment with the CAMRIS PBF business model.
- Preparing labor and budget forecasts that anticipate facility, equipment, and workforce needs in coordination with the Vice President of Programs.
- Assembling schedules and performance reports (in SmartSheet, Microsoft PowerPoint, Microsoft Excel, and Microsoft Word) measuring and reporting program performance against the metrics established for the program.
- Timely creation and delivery of PBF Monthly Reports summarizing accomplishments, financial variances, and noteworthy challenges to the program.
- Leading, Coordinating, and participating in re-occurring PBF team meetings between CAMRIS and WRAIR.
- Direct leadership and interface with PBF clients as required to optimize PBF productivity, quality of services and advance PBF capabilities in accordance with pOTA mission requirements.
- Hosting and coordinating customer meetings, tours, and calls, as needed.
- Build and institutionalize the PBF's Project Management Office (PMO) from the ground up. This includes setting up workflows, roles, and governance structures for optimal functionality and value to the PBF
- Lead the PMO team and strategically deploy resources to manage and deliver over 20 successful process development and manufacturing projects, ensuring that they meet the defined scope, schedule, cost, and quality criteria.
- Streamline current processes and workflows to optimize efficiency and productivity. Identify gaps, implement best practices, and develop tools and standards that enhance performance across the entire PBF project portfolio, including process development, manufacturing, and site projects.
- Build, nurture, and maintain strong relationships with current and prospective clients, both government and private entities. Understand their needs, concerns, and aspirations to deliver solutions that exceed expectations.
- Develop Gantts, including workforce resource assignments for each program.
- Evaluate schedule constraints, risk, and feasibility of performing projects.
- Assist managers with subcontractor schedule development and maintenance.
- Support shutdown planning and execution and update capacity utilization metrics.
- Optimize and scale the PMO as capacity grows.
- A bachelor's degree in business, engineering, life sciences, or a related field and 14 years of biologics development or manufacturing industry experience or an equivalent combination of credentials and experience.
- MS Project proficiency, including resource planning.
- MS Excel, MS Word, MS SharePoint, and MS Teams familiarity.
- Familiarity with implementing operational excellence.
- Excellent written and verbal communication skills.
- Must be currently eligible to work in the United States without visa sponsorship and have lived in the United States for three of the past five years if a non-US citizen.
- Biologics experience in development, manufacturing, or engineering.
- PMP and/or earned value training.
- Experience with cost analysis is a plus.
- CDMO project management experience.
- Capital project management experience.
- SmartSheet experience.
- Leadership experience.
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PMO Manager - Silver Spring, United States - CAMRIS
Description
We are seeking a PMO Manager to support the Pilot Bio-Production Facility (PBF) at the Walter Reed Army Institute of Research (WRAIR) in Silver Spring, Maryland. PBF is a one-of-a-kind cGMP-compliant pharmaceutical manufacturing facility engaged in next-generation development for cutting-edge companies and government agencies. The professionals at PBF engage in trailblazing endeavors every day. Most exciting, the end products vary, so every year brings multiple opportunities for professional enrichment in original projects.
CAMRIS International, LLC, is a dynamic medical research and development firm that achieves innovative solutions to health and development challenges through high-quality, cost-effective programs and research management services. We combine our proven systems with today's most effective, evidence-based best practices. Our core practice areas include vaccine research, development, and production; microbiology and infectious disease research; biodefense; clinical research; global health security; and HIV/AIDS programs.
Our employees enjoy a diverse, collegial environment where individual contributions matter at all levels. At CAMRIS, you will notably improve the lives of people at home and abroad.
Responsibilities
Qualifications
Required
Preferred
CAMRIS International LLC offers competitive salaries and comprehensive benefits. Please submit your resume online at CAMRIS is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status, disability status, or any other characteristic protected by any applicable federal, state, or local law.
Some positions or sites may require that the incumbent be fully vaccinated against COVID-19. Proof of vaccination may be required.
Employment is contingent upon the successful completion of a background check, a requirement for this position under an active federal contract. The background check process may include, but is not limited to, the following: (1) contacting your professional references; (2) verification of previous employment, education, and credentials; (3) a criminal background check; (4) use/abuse of federally-controlled substances; and (5) a department of motor vehicle check. Candidates must be prepared to fully complete any required background check questionnaire during initial onboarding.
