The main responsibilities will include but are not limited to:
• Create, implement, and execute project plans and timelines to achieve client and corporate goals. Determine activities required and prepare a detailed scope of work specific for each contract.
• Establish and implement milestones, schedules and timelines; resources required to perform activities; preparing and managing contract budgets; identifying areas where subcontractors are required, reviewing proposals and selecting optimal subcontractors for the project; determining potential areas of difficulties and preparing back-up strategies and subcontractors.
• Responsible for the creation, tracking and use of financial resources for reporting to Executive Management.
• Carrying out project plans for each contract as defined by the scope and activities; evaluating overall resource capabilities of in-house and subcontracted activities on a regular basis; managing subcontractors; utilizing a database to store all information regarding the products prepared under contract; communicating all project issues/needs to client representative, Principal Investigators and Executive Management and ensuring that all deliverable goals are met within defined scope and payment terms for contracts.
• Evaluate go/no-go decision points in order to ensure that contracts are on the desired path and have the potential to move ahead in the development process. Offer solutions and troubleshooting to potential or perceived risks that impact technical direction, quality costs and timeline for contracts.
• Ensure that contract priorities, as well as those of the client, and decisions are communicated, are consistent between teams, and support the overall programs according to client expectation and needs.
• Ensure contract scope and costs modifications are reviewed, negotiated and provided to contracts to execute in a timely manner.
• Delegate complex project workloads; maintain an understanding of all projects within the group, set goals and objectives.
• Support on-going continuous improvement and cost containment programs to design more efficient ways to schedule and execute portfolios, as well as evaluate the use of alternative procedures to improve efficiency to reduce costs. Forecast and manage invoice and revenue recognition and profit/loss evaluations for contracts and projects.
• Monitor various intellectual property issues in coordination with our client’s legal representation.
• Oversee contract deliverables, prepare thorough reporting deliverables of multiple contracted agreements.
• Other duties as assigned may include but not be limited to, participation on assigned projects and teams.
KNOWLEDGE AND EXPERIENCE REQUIRED FOR THE JOB:
• BS/MS in a scientific related field of study or equivalent.
• 10-15 experience in a biomedical development and clinical process setting for infectious diseases. Previous hands on working knowledge of process development and cGMP manufacturing for biologics.
• Strong preference for candidates with direct experience at a Contract Manufacturing Organization (CMO) that offers GMP and process development services.
• Proven aptitude for project management tools. Project Management Certification a plus.
• Experience with managing and overseeing subcontractors supporting commercial or government clients preferred.
• Ideal candidate will have experience managing financial goals by forecasting requirements, tracking annual budgets, scheduling expenditures, analyzing variances, reporting revenue recognition, preparing technical progress reports and communicating financial summaries.
• Proficiency using project management tools to oversee all elements of project lifecycle including scheduling/planning, meeting coordination, tracking of deliverables, reporting to stakeholders and risk mitigation.
• Demonstrated ability to work as a strong contributor in a team environment on complex projects.
• Outstanding demonstrated interpersonal skills a must (both written and oral)
• Proven multi-tasking skills able to handle multiple projects simultaneously; ability to motivate teams, work within aggressive timelines collaboratively with cross-functional departments
• Proven and demonstrated computer (PC) and software skills including MS Office Suite programs, Internet, email systems a must. Experience with Microsoft Excel and Microsoft Project is required.
• Demonstrated ability to work as a strong contributor in a team environment and able to interaction with all echelons of management and staff.
• Must be detail-oriented, dependable, motivated, ability to work with minimal supervision; Proven multi-tasker able to handle multiple projects well;
• Strong/effective interpersonal skills, both communication and written & able to communicate effectively with all echelons of Management and staff
· Candidate must meet all the requirements of our Company Occupational Health program as directed by the Occupational Health Consultant to include pre-employment physical and drug screen.
· Candidates are encouraged to submit a resume and a cover letter outlining background and experience as it relates to the position requirements and salary history/requirements. Please note that "negotiable" is neither salary nor requirements. Salary commensurate with experience.