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Senior Project Manager

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POST DATE 8/26/2016
END DATE 12/19/2016

Biotechnology Gaithersburg, MD

Gaithersburg, MD
AJE Ref #
Job Classification
Full Time
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Our client is an international company providing contract manufacturing and research services in the fields of immunology, vaccines, and biotherapeutics, from cell line and process development, to GMP manufacturing, QC release testing and regulatory support. They have asked Hallmark to help them find a Sr Project Manager to augment their staff. The person in this role will lead the planning and execution of clinical immune-monitoring testing, and manage cross-functional project teams supporting testing activities for the development of immunoassays. This is a staff position with great benefits and excellent career potential.


* 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.
* The creation, tracking and use of financial resources for reporting to Executive Management.
* Carry 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 legal representation.
* Prepare and oversee contract deliverables.
* Offer insight towards establishing a PBMC repository for functional cellular studies in support of clinical vaccine trials.


* BS or MS in a scientific, related field of study.
* 10+ years of experience in a biomedical development and clinical process setting for infectious diseases.
* Previous experience in process development and cGMP manufacturing for biologics is strongly preferred.
* Experience working for a Contract Manufacturing Organization (CMO) that offers GMP and process development services is strongly preferred.
* Project Management Certification (PMP) is a plus.
* Experience managing subcontractors is preferred.
* Experience managing project - based financial goals (_ex: 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.
* Able to handle multiple projects simultaneously, motivate teams, and work within aggressive timelines 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.
* Able to work as a strong contributor in a team environment.
* Must be detail-oriented, dependable, motivated, and organized, with the ability to handle multiple projects well;
* Effective interpersonal skills, including strong written and verbal communication skills, and the ability to communicate with peers, clients, and management alike.
* Must be able to pass pre-employment physical and drug screen.


Hallmark and our Client are Affirmative Action, Equal Opportunity Employers. We encourage all qualified people with the current right to work for any employer in the USA to apply. NOTE: We cannot consider H-1 Visa candidates for this position. Principals only, please.