GMP Senior Project Manager

We are seeking a GMP Senior Project Manager to support the Pilot Bioproduction 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 engaging in next-generation development for cutting-edge companies and government agencies. The professionals at PBF are engaging 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 collegial environment where individual contributions matter at all levels. At CAMRIS, you will notably improve the lives of people at home and abroad.

• Manage 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.
• Assemble 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.
• Lead, coordinate, and participate in re-occurring PBF team meetings between CAMRIS and WRAIR.
• Hosting and coordinating customer meetings, tours, and calls, as needed.
• Help 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.
• 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.
• Direct leadership and interface with PBF clients as required to optimize PBF productivity and quality of services and advance PBF capabilities in accordance with pOTA mission requirements.
• Implementation and continuous improvement of manufacturing of PBF Manufacturing procedures, policies, and systems in alignment with or exceeding industry standards.
• Preparing labor and budget forecasts that anticipate facility, equipment, and workforce needs in coordination with the Vice President of Programs.
• Standardize 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.
• Develop, maintain, support, and manage project management tools in SmartsheetGov.
• Assist managers with subcontractor schedule development and maintenance.
• Optimize and scale the PMO as capacity grows.
• Support the use of SmartsheetGov for Tier issue tracking and analysis.
• 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.
• Support shutdown planning and execution and update capacity utilization metrics.
• Support mentoring of junior-level Project Management staff.
• Perform other duties as assigned.
  

Required

• BS/BA in business, engineering, life sciences, or a related field and 12 years of biologics development or manufacturing industry experience or an equivalent combination of education 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.

Preferred

• 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.

Physical Requirements, Workplace Hazards and Conditions, and PPE and Chemical Requirements



The physical requirements, workplace hazards and conditions, and PPE and chemical requirements described here are representative of those that a candidate must meet to perform the essential functions of this job. Reasonable accommodation may be provided to enable individuals with disabilities to perform essential job functions.

Physical Demands

• Constantly conduct sedentary work that primarily involves sitting/standing.
• Occasionally conduct light work that includes moving objects up to 20 pounds.
• Occasionally push or pull less than 25 pounds.
• Occasionally reach above shoulder level.
• Constantly use both hands.
• Occasionally bend, reach, or twist repeatedly.
• Occasionally kneel, squat, or stoop.
• Constantly have clear vision (near and/or far), depth perception, peripheral vision, and/or visual acuity.

Physical Activities

• Occasionally move about to accomplish tasks or move from one worksite to another.
• Constantly communicate with others to exchange information.
• Constantly assess the accuracy, neatness, and thoroughness of the work assigned.

Environmental Conditions

• Constantly work in environments where no adverse environmental conditions are expected.

Please submit your resume online at www.CAMRIS.com . 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. CAMRIS offers a comprehensive benefits package, including medical, dental, and vision insurance for individuals and families, FSAs, HSA, life and AD&D insurance, short- and long-term disability, legal services, voluntary hospital indemnity, critical illness and accident insurances, EAP, pet insurance, 401(k) with employer match and Roth option, tuition and professional reimbursement, public transportation support in the DMV area, a referral bonus program, vacation with tenure-based increases, PTO, 11 paid holidays, paid bonding leave, and paid supplemental short-term disability. Employment is contingent upon successful completion of a Public Trust-level 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.

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