Job Type
Full-time
Description
Job Summary
This position is primarily responsible for the management of supervisors and their teams of analysts whose activities consist of laboratory testing of cleaning validation/verification samples, raw materials, packaging materials, in-process, release and stability samples for pre-commercial drug products and method transfers, including communication of lab testing completion dates to internal customers and oversight of lab investigations. The Manager - Analytical Services is also responsible for the continued monitoring and improvement of current testing methods. The position also has oversight of personnel responsible for the reference standard program, evaluation of new raw materials and new packaging materials, monitoring compendial publications and evaluating the impact of proposed changes and material impact assessments for equipment investigations.
Scope of Job
Manage 1 or more teams consisting of a supervisor, a team leader and 6 or more analysts that are responsible for testing of various samples. The position also manages a compliance specialist responsible for the reference standard program, the validation of Excel spreadsheets, and monitoring compendial publications and evaluating the impact of proposed changes. This position also manages a technical writer responsible for the generation of eCTD CMC laboratory related information for submissions related to commercial drug products and the creation/revision of laboratory specifications and methods. This position also oversees a lab technician responsible for the procurement of lab supplies as well as the cleaning/storage of labware. Approve purchases of lab consumables, supplies and capital expenditures and ensure overall spending is at or below budget.
Responsibilities
Testing/Project Support
• Ensure testing is completed on or before assigned due date
• Communicate material issues or testing delays to the appropriate internal customer(s) (i.e. Supply Chain, Production and Packaging)
• Oversee personnel responsible for the management of the reference standard program
• Oversee personnel responsible for monitoring compendial publications and evaluation of proposed changes
Support incoming R&D projects by attending project meetings and providing appropriate guidance for future lab testing
Lab Investigations
• Facilitate timely investigations of out-of-specification and out-of-trend data and communicate to upper management
Assist in determining root causes, appropriate CAPAs, and assessing the effectiveness of the CAPAs
Key Performance Indicators
• Responsible for managing teams' performance and applicable quality metrics
• Challenge current procedures and practices to improve throughput, systems, efficiency, and quality
• Approve purchases of lab consumables, supplies and capital expenditures and ensure overall spending is at or below budget
Identify and implement new or improved systems or programs to remain current with industry compliance trends
Documentation
• Manage personnel responsible for the eCTD CMC laboratory related information for submission as related to commercial drug products
Perform critical review and approval of method transfer and investigation protocols/reports
Personnel
• Evaluate proper staffing and equipment needs
• Manage personnel including interviewing, hiring, performance reviews, disciplinary action, goals/objectives, rewards, coaching, training, etc.
Assess and document employees' performance appropriately to ensure ongoing integrity of the testing results and help to ensure the quality of the site's drug products
Requirements
Experience
• BS Degree in Chemistry or related field
• Minimum of 7 years of pharmaceutical product analysis experience in a cGMP-regulated lab environment
Minimum of 3 years of experience in supervision
Specific Skills
• Knowledge of cGMP, USP/NF, ICH, DEA, EU and FDA guidelines and regulations
• Competent in analytical methods and lab instrumentation (e.g. HPLC, GC, dissolution, wet chemistry)
• Excellent oral and written communication skills
• Strong organization, time management, leadership, troubleshooting and investigation skills
• Expertise in Microsoft Word and Excel
Experience with software associated with a Quality Management System (QMS), a Laboratory Information Management System (LIMS), and a Chromatography Data System (CDS)
Physical Requirements
• Work mainly performed in office environment with periodic visits to lab
Travel < 5%
