Title:  Mgr, Laboratory, LN

Job Summary

Essential Duties and Responsibilities

• Manage the day-to-day business for routine testing (up to 4 individual teams) including capacity planning
• Lead Tier 2 meetings, prepare and report lab statistics/KPIs to Tier 3
• Manage the global lab network support testing (Product bag release testing, support testing)
• Give technical support and guidance on quality processes to laboratory supervisors
• First point of contact for request regarding laboratory management from local or global positions
• Mitigate critical backlog situations and escalate as necessary
• Provide guidance on prioritization to the lab team based on input from site management
• Responsible for training processes in the lab including training of new test supervisors
• Approve for laboratory management in quality processes, e.g. CAPA, Deviation, Laboratory Investigations, and ensure timely closure
• Implementation of processes and procedures to ensure on-time delivery of all testing in compliance with cGMP and regulatory guidelines/industry standards and local and global safety guidelines
• Review and approve documents such as laboratory investigations, work instructions, SOP’s, etc.
• Participate in cross functional teams as laboratory operations leads to provide input and consultation for laboratory testing and projects.
• Keep current with new technologies and cGMP regulations
• May have people management responsibilities

Education

• Bachelor's Degree in Science with focus on Bachelor's Degree in Science with focus on Chemistry, Microbiology or related scientific area required and
• Graduate degree preferred

Work Experience

• Minimum 8 years Of experience of management experience, GMP testing, analytical testing and instrumentation required

Preferred Knowledge, Skills and Abilities

• Ability to take initiative, to work efficiently to meet deadlines, and to work in a team environment are essential
• Able to work independently and remain self-motivated with minimal direct supervision
• Highly organized, thorough, and possess and practice good record keeping skills
• Good communication skills
• Service orientation
• Technical understanding
• Strong analytical and problem solving skills. Superior verbal/written skills
• Good punctuation, spelling, grammar and attention to detail
• Resilience and ability to work in a team
• Continuous willingness to undergo further training
• Independent way of working
• Conforms with and abides by all regulations, policies, work procedures, instructions, and all safety and quality rules
• Must function effectively in a diverse, cross-functional team
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Able to comply with the company’s safety policy at all times
• Able to comply with the company’s quality policy at all times
• Able to follow directions, prioritize tasks, and work independently
• Must have excellent interpersonal, written and verbal communication skills
• Must be proficient in Microsoft Office tools and capable to learn other software programs
• Able to review regulatory code and learn safety standards
• Occasionally come in earlier than their normal afternoon start time

Travel Requirements

Additional Requirements

• Job-related activities that require a physical activity such as standing in laboratory environment
• Use hands to finger, handle, feel or operate objects, tools or controls and reach with hands and arms.
• Job-related activities that require a mental skill or ability such as communication, quick decision making, interpreting data, reading or writing, public speaking, etc. (e.g., Must be able to express or exchange ideas with employees; Must be able to understand direction and adhere to established procedures)