PAI

Primary

Purpose:

Help provide leadership that ensures efficient production that is scientifically sound and regulatory compliant.

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 organizationPAIs to ensure projects are appropriately staffed

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, to discuss possible risks of projects

Advocating for both the internal and external clients

Understanding and managing clients’ expectations with assistance as needed

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

Manage 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 ensure execution:a) Relating analytical data to study objectives as the study progresses, in “real time” b) Reviewing technical data Managing studies to meet GLP, CDER, CVM, ICH, FIFRA, VICH, or applicable regulatory guidance

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

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

Experience:

Bachelor's Degree in Chemistry or related Scientific field with 6-8+ years experience is required
-OR-Master's Degree or equivalent in Chemistry or related Scientific field with 5+ years' experience is required
-OR-Ph.D. or equivalent in Chemistry or related Scientific field with 2+ years experience is required
* Significant work experience will be considered as a substitution for education

Knowledge, Skills, and Abilities:

General understanding of the technical knowledge to ensure operational efficiency of Laboratory Operations within the business program

General knowledge of instrumental analysis, including mass spectrometry and chromatography

General knowledge of current industry guidance and regulations

Oral and written communication skills, including comfort in calling and talking with customers on the telephone, when in-person interactions are not possible

Strong attention to detail; the ability to manage large numbers of competing requirements is absolutely mandatory

General understanding of customer perspective for bioanalytical regulatory development programs

Relevant expertise to ensure technical quality, suitability of data for the intended purpose, and operational efficiency of projects execution

General GLP regulatory and experimental design experience

Preferred Qualifications:

Mass spectrometry or HPLC experience.

Advanced knowledge of Watson LIMS.Advanced knowledge of Excel.

Current experience with industry and regulatory guidance