Job Description
JOB DESCRIPTION
Level: SME 2
Function: Operations
Primary Purpose : Provide leadership that ensures efficient production that is scientifically sound and regulatory compliant. Responsible for helping implement efficiency improvements in overall productivity.
Job Duties and Responsibilities:
- Planning, coordinating and organizing, including efficient productivity, scheduling, and forecasting resources (e.g., liaising with different departments to working on allocation, utilization and direction of company resources cross-functionally)
- Maintaining knowledge of status/progress for projects across different departments
- Monitoring productivity to help meet monthly revenue goals and overall goals of the organization
- Ensure incoming projects are feasible from an overall organizational standpoint so that Aliri Labs Inc. can successfully meet client deliverables
- Acting as the interface between Laboratory Operations, QA, and Reporting
- Scheduling and coordinating, including directing others, to ensure overall successful completion of studies
- Communicating frequently and effectively as the main point of contact with the client, providing updates on ongoing programs
- Engaging Laboratory Operations throughout the entire productivity process; planning, developing and implementing, as well as sharing impact of efforts, including helping distribute risk evenly between all projects
- Advocating for both the internal and external clients
- Completely understanding and managing clients’ expectations
- Including the entire project team in communications throughout project
- Ensuring that all results meet internal and/or protocol specifications
- Ensuring that the study design, results, and interpretation address changing stakeholder needs
- Support studies; project initiation planning; helps both customers and laboratory staff to interpret data and adjusts the bioanalytical development approach. Support internal resources and customers by applying current scientific, regulatory, and project management expertise to establish experimental design and support execution:
- Relating analytical data to study objectives as the study progresses, in “real time”
- Reviewing technical data
- Supporting studies to meet GLP, CDER, CVM, ICH, FIFRA, VICH, or applicable regulatory guidance
- Writing or assisting in writing content for technical-regulatory study protocols, plans, and reports
- Reconciling data and report reviews, as well as archival approval
- Applying data evaluation techniques and tools (e.g., Analyst®, JMP®, Microsoft Excel, etc.) to assess analytical phase data
- Think like a business person. Understand the business need for each project and make on-going decisions based on what’s best for the organization—even if that means challenging senior stakeholders on critical success factors.
- Must have a proven record of success in your previous projects.
Experience:
Bachelor's Degree in Chemistry or related Scientific field with 8-10+ years experience is required -OR- Master's Degree or equivalent in Chemistry or related Scientific field with 7+ years experience is required -OR- Ph.D. or equivalent in Chemistry or related Scientific field with 5+ years experience is required
Knowledge, Skills, and Abilities:
- Strong understanding of the technical knowledge to ensure operational efficiency of Laboratory Operations within the business program
- Proficient knowledge of instrumental analysis, including mass spectrometry and chromatography
- General knowledge of current industry guidance and regulations
- Ability to build lasting client relationships and support marketing and sales activities
- Strong oral and written communication skills, including very strong bias toward calling and talking with customers on the telephone, when in-person interactions are not possible
- Very strong attention to detail; the ability to manage large numbers of competing requirements is absolutely mandatory
- Understanding of customer perspective for bioanalytical regulatory development programs
- Technical expertise to ensure technical quality, suitability of data for the intended purpose, and operational efficiency of projects execution
- GLP regulatory and experimental design experience
- Forecasting, planning, and interdepartmental facilitation skills
- Integrating the commercial and technical aspects of laboratory operations
Preferred Qualifications:
- Mass spectrometry or HPLC experience.
- Advanced knowledge of Watson LIMS.
- Advanced knowledge of Excel.
- Current experience with industry and regulatory guidance
Working Conditions:
- Office environment with occasional laboratory exposure
- Essential physical requirements include going up/down stairs, typing, and sitting or standing for long periods
- Physical effort requirements are moderate (ranging from sedentary to lifting boxes up to 10-15 pounds)
- Occasional long hours and/or weekends during peak production cycles and/or staff absences
- No travel requirements unless attending off-site training
Benefits offered to full-time Aliri Bioanalysis employees:
- Medical and Dental Insurance through Cigna
- $3,200 Qualified High Deductible Health Plan with an employer HSA contribution
- $1,500 PPO Copay Plan, with choice of FSA
- Dental PPO Plan
- Vision insurance through VSP
- Additional life insurance options
- Employer Paid Basic Life & Accidental Death & Dismemberment (AD&D)
- Accident and Critical Illness and hospital indemnity plan
- Health savings and Flexible spending accounts
- Bonus Plans and rewards and recognition programs
- 401K with matching
- Fitness and Warehouse Club reimbursements
Job Tags
Full time, Flexible hours, Weekend work,