The Project Directors will act as the responsible person to lead and direct scientific work to support analysis of assays for non-regulated, GLP-regulated, GCP-regulated and commercial diagnostic (CLSI, CLIA) regulated studies across all scientific teams; Bioanalytical, Companion Diagnostic, Flow Cytometry and Cell Biology. The Project Director will work effectively across multiple scientific teams to direct the delivery of study milestones within cost, time, and quality requirements. Strategically leads projects, as well as communicates with external partners, consultants, and monitors project financial budgets to ensure we delivery study milestones on time and within the defined scope of work.
Essential functions of the job include but are not limited to:
- Manage multiple projects and the ongoing work activities associated with a project across the PfM Specialty Lab.
- Act as a single, authoritative source of study information and leads study level status reporting per client; lead the analysts and drive associated deliverables across all functions for assigned projects; accountable for managing and driving overall study timelines, budgets, and quality targets to meet or exceed business needs.
- Accountable to ensure effective study team scheduling, records, and communications.
- Define optimal operational strategy and define timeline, resourcing, and budget needs for execution of the study plans that defines scope of work.
- Establish and ensure adherence to operational standards and best practices across projects.
- Ensures the timely execution of projects with a focus on quality deliverables. Facilitates hand-off meetings and kick-off meetings to identify potential risks and work with the project team to develop and communicate contingency plans.
- Ensures project risks and potential contingencies impacting time/quality/cost of deliverables are discussed with customers and senior leaders through appropriate escalation pathways.
- Serves as the initial point of communication for customer issues. Communicates with customer(s) regularly to obtain direction and feedback on implementing scope of work as well as performance to date.
- Identifies unusual or significant problems encountered during the course of a study and proposes strategies for preventing or correcting significant problems with supervisor oversight.
Qualifications:
Minimum Required:
Bachelor’s degree in a life science or related field (e.g., engineering), plus a minimum of 2 years of project management; in some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Other Required:
- Outstanding leadership skills
- Excellent judgment and decision-making skills
- Direct experience in oversight of ELISA, MSD and Nab assays
- Experience working in a regulated environment, preferably GLP or GCP
- Knowledge of project management principles and application
- Financial acumen with knowledge of budgeting, forecasting, and resource management
- Knowledge of regulatory guidelines and directives
- Knowledge of laboratory and laboratory terminology
- Able to read, write, and fluently speak and comprehend the English language
- Proven track record of being a team player, willing to interact proactively and productively
Preferred:
- Master’s or PhD in Biology, Biochemistry, Immunology, Cell Biology, Molecular Biology or related field
- Experience in cellular, molecular or biochemical science such as hands-on research or lab experience in cellular biomarker analysis, protein-based assays, next-generation sequencing, IHC, or PK/PD assays
- Experience with project management software
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