Extractables & Leachables Group Leader III

Perform both technical and personnel aspects of group operations; performing work within the department or other areas as required; act as a technical resource, trainer, and troubleshooter to specific department, make recommendations for operational and/or technical improvements; communicate effectively within the group; coach and develop direct reports, plan and monitor workflow, monitor data and support departmental MOS; demonstrate and strengthen leadership qualities.

Essential Duties and Responsibilities:

Work Standards:

• Applies GMP/GLP in all areas of responsibility, as appropriate 

• Applies the highest quality standard in all areas of responsibility 

• Demonstrates and promotes the company vision 

• Demonstrates strong client service skills, teamwork, and collaboration 

• Proactively plans and multitasks to maximize productivity 

• Meets all quality and productivity metrics and demonstrates strong teamwork and collaboration 

• Regular attendance and punctuality 

• Support and promote company policies and procedures 

• Proactive and effective escalation to appropriate management 

• Proactively plans and multitasks to maximize productivity of self and direct reports 

• Ensure that the quality policy program is understood, implemented, and maintained; identify, prevent, or correct any departures from the quality system 

• Enforces safety policies across all areas of responsibility 

• Perform laboratory tasks as required to deliver on department objectives 

• Perform all functions in support of and in compliance with all state and federal employment regulations 

• Monitor and control cost 

• Review and approve quotes as role requires. Identify and take action when pricing is inaccurate

• Communicates effectively with client staff members 

• Conducts all activities in a safe and efficient manner 

• Performs other duties as assigned

Leader of Direct Reports: 

• Foster a positive and professional work environment 

• Communicate a clear vision and motivate staff to excel 

• Monitor and approve employees’ time worked through time-entry system 

• Follow communication plan policy for regular meetings as directed by your business unit 

• Coach, train, and develop others within the group with respect to their personal development to maximize performance 

• Manage workflow and perform daily monitoring to meet customer service needs and KPI 

• Conduct semi-annual performance reviews and interview applicants 

• Perform training record review for direct reports 

• Ensure data integrity record keeping to maintain compliance 

• Confront and address problems, concerns and performance issues in real time 

• Expand self-awareness and develop leadership skills as defined; attend applicable leadership training based on identified needs 

• Effectively delegate and exercise accountability of self and others 

• Perform succession planning in preparation for growth of team and self

Additional Responsibilities of Scientific Group Leader III:

Empower: Record of mentoring any technical level staff. Advise and consult for group leader peers

Customer Obsession: Independently act as technical lead in calls/audits for complex projects and start to act as lead for escalated issues.

Numeracy: Participate in pricing catalog evaluation. Assist in the scope evaluation of complex program quotes. Build basic understanding of financial acumen

Technical Knowledge/Decision Making: Deep understanding of instrumental and/or analytical theory for all technical disciplines they oversee and provides support beyond own team.  Ability to independently drive complex investigations. Comprehensive understanding of investigation impact on the business within department.

Initiate Change/Execution: Highlight and provide justification for laboratory needs for current operation and future state through assessment of new techniques, technologies, instrumentation, space, KPI headcount, while monitoring and controlling cost. Propose and drive new LEAN initiatives across department and division

Extractables & Leachables Testing (Dept 2005)

Background:  Bio/pharmaceutical container closure systems, delivery systems, and manufacturing components may contain additives that can leach into the final drug product.  These leachable compounds may pose potential health risks to the patient by increasing the drug’s toxicity or reducing its efficacy.

What do we do:  The Extractables & Leachables Testing department evaluates container closure systems, delivery systems, manufacturing components, and medical devices for extractable and leachable compounds.  This process involves exposing the materials to extraction solvents and then testing the resulting extraction solutions by a variety of analytical techniques.  These screening methods require extensive data interpretation in order to identify the compounds using proprietary databases.

Center of Focus: 

• Extractables – team members will perform worst case extractions on various materials and then test the resulting extraction solutions to determine what compounds may be extracted out of the materials under exaggerated conditions

• Leachables – team members will test drug product that has been stored in the container closure system to determine what compounds will leach out of the materials and into the drug product under the actual conditions of use.

• Development and Validations – team members will establish method conditions that meet the intention of the analytical method and then perform a series of tests (e.g., precision, accuracy, linearity, specificity, and sensitivity) to ensure the method is appropriate for its given function.

• Unknown Peak Identifications – team members will perform investigative testing in an effort to identify unknown compounds.  This testing typically relies on mass spectrometers that are capable of fragmenting the unknown compound.

Instrumentation and testing techniques:  Liquid Chromatography Mass Spectrometry (LC/MS), including Time-of-Flight (TOF), Quadrupole Time-of-Flight (QTOF), and Triple Quad (MS/MS) LC/MS systems; Headspace and Direct Injection Gas Chromatography Mass Spectrometry; High Performance/Ultra High Performance Liquid Chromatography (HPLC/UPLC); Inductively Coupled Plasma Optical Emission Spectroscopy (ICP-OES); Inductively Coupled Plasma Mass Spectrometry (ICP/MS); Microwave Digestion; Various Laboratory Equipment (including balances, pH meters, sonicators, and centrifuges).