Director of Operations

Position Summary:

The Director of Operations will use their regulatory knowledge, scientific expertise leadership skills to manage the execution of clinical sample analysis projects supporting multiple fast-paced clinical and non-clinical studies for clients engaged in cutting-edge research.  As a team leader with direct reports, the person will train and mentor staff to ensure scientific rigor and use their expertise to meet deliverables according to mutually agreed-upon timelines.  The position requires direct experience in overseeing clinical sample analysis operations and the Director of Operations is preferred to have working knowledge of regulatory guidance and industry best practices.  Lastly, the incumbent will be responsible for helping to provide both short term and long-term financial forecasting for the Lab team.

 

Essential functions of the job include but are not limited to:

• Oversee the laboratory staff at the site.
• Collaborate with Project Managers, Management, Scientific Leads, and Operational Scheduling Leads to effectively prioritize and communicate daily activities for team members in order to achieve meet analytical demand.
• Mentor team leads to ensure team members are working efficiently and delivering high quality data.
• Serve as a liaison for the scientific leads to help support organization of tasks and requirements prior to testing and escalation to appropriate parties for to address identified gaps that have potential impact to scheduled work
• Responsible for the operational scheduling and forecasting for Labs, coordinate with the Scientific Leads to forecast work across the life of all projects
• Support the managers and process for new hires and ensure that team members are trained in a compliant manner consistent with their job duties
• Ensure that laboratory equipment is maintained to meet regulatory compliance and analytical demand
• Review direct report timesheets to ensure accurate reporting based on work completed
• Support client calls as needed with technical staff and PMs to help resolve issues
• Manage and control departmental expenditure within agreed budgets
• Establish and/or maintain appropriate metrics for measuring necessary aspects of operational management and development of cross functional laboratory training programs
• Identify bottlenecks in the laboratory to improve overall efficiencies
• Carry out other duties/projects as assigned

Qualifications:

 

Minimum Required:

• PhD in Immunology or related field with 5+ years’ relevant experience or MS degree with 8+ years’ relevant experience or BA/BS degree with 10+ years’ relevant experience
• At least 4 years in CRO or healthcare organization leading teams supporting Bioanalysis, Flow Cytometry,cell-based assays or other scientific assays

 

Other Required:

• Must have demonstrated experience leading teams of scientists in performing regulated analytical work
• A solid understanding of current GLP, GCP or GCLP standards
• Working knowledge of CAP/CLIA and ISO 9001
• Understanding of analytical lab workflow including sample requisition, analysis, quality control, data tabling and reporting.
• Excellent communication, interpersonal, organizational and multi-tasking skills
• Must be proficient with Microsoft Word, Excel, and PowerPoint
• Ability to interact and function in a highly productive work environment
• Ability to work independently and have good attention to detail
• Ability to lift and carry between 1-15 lbs.; Ability to lift up to 50 lbs. overhead with assistance; frequently required to sit, grasp, and use right/left finger dexterity; May be exposed to a cold freezer environment (Freezer temperatures range between -20ºC -196ºC)
• Must be able to read, write, speak fluently and comprehend the English language

 

Preferred:

• Experience in the use of LIMS and ELN for clinical sample testing
• Experience in Lean Six Sigma

Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the