Title:  Lab Manager

Job Summary

• In this role, you will be responsible for overseeing day-to-day analytical testing activities to support West Vantage. The laboratory testing will include release testing for marketed drug products and may be responsible for method development and validation of test methods.  
• Manage the team to ensure compliance with processes and procedures to reduce risks and improve compliance and productivity. Implement and achieve team metrics, provide directions to analysts, and manage their performance.  
• Must have a technical background in analytical chemistry or related field. In addition, you will coordinate where appropriate with the Plant Management team at the site location. 
• West is expanding in Indiana with a cutting-edge manufacturing facility designed to drive innovation, quality, and operational excellence.  

We are seeking forward-thinking professionals who excel in fast-paced settings, lead with integrity, and value teamwork and continuous improvement. If you are energized by building something new, fostering collaboration, and driving impact in a purpose-driven industry, this is an opportunity to help shape the future of West and accelerate our mission to improve patient lives globally.  

Essential Duties and Responsibilities

• Responsible for ensuring Safety practices are employed and collaborate with all lab teams for improvements and knowledge sharing 
• Apply required cGMP regulations and internal QA procedures  
• Drive continuous improvement of Safety, cGMP/Data Integrity and Efficiency across lab groups 
• Manage the day-to-day activities which include resource management (labor, materials, equipment, etc.), investigation management, due date compliance, time tracking compliance, and performance reviews 
• Knowledge and understanding of laboratory techniques: Method development and validation, drug product chromatography testing, performance testers such as Zwick or Instron, functionality testing, other analytical techniques as the laboratory grows 
• Local Lead for laboratory facility set up. 
• Engage directly with customers to address their needs, resolve issues, and foster a collaborative relationship 
• Lead collaboration amongst technical and facility management for new lab services 
• Lead and / or support new technology evaluations and implementation into the laboratory 
• Assure that analysts have been adequately trained for their role . 
• Assure that contract laboratory employees are in compliance with local procedures.  
• Work together with plant management team at site location 
• Assist management in proper management of resources of the group including analyst work assignments 
• Lead new instrument purchase and assist in install and qualification  
• Manage method transfers and development/validation  
• Manage and collect time tracking and assure due date compliance 
• Assist with the development of systems for evaluation of metrics, work assignments and monitoring analyst productivity for the group. 
• Approve laboratory investigations to support external customers  
• Local lead for customer and regulatory audits as appropriate  
• Provide direction to his/her group and assist in providing systems and direction to control costs, reduce risks and improve productivity 
• Assure Safety procedures are followed and identify any safety risks with preventative actions 
• Assure cross training, minimum of two people trained to perform testing 
• Drive continuous improvement relative to laboratory functions 
• Perform additional duties at the request of the direct supervisor 

Additional Responsibilities

As an early member of our newest West site, you will thrive if you can:  

• Bring a positive, can-do attitude every day as we build and grow together. 
• Contribute to ramping up a state-of-the-art manufacturing facility from the ground up. 
• Embrace change and innovation as we launch new operations at record speed. 
• Work hard, stay flexible, and support your teammates to achieve shared goals. 
• Take pride in producing high-quality products that improve patient lives worldwide. 
• Live West’s core values of integrity, teamwork, and accountability in everything you do. 
• Be part of a culture that celebrates learning, problem-solving, and continuous improvement. 
• Show initiative and ownership while helping shape a safe, efficient, and high-performing workplace. 
• Grow your career and skillset in a dynamic, innovative environment where your contributions truly matter. 
• Work independently and take initiative in areas that may not be formally assigned to you. 
• Thrive in ambiguity and see change as an opportunity rather than a challenge. 
• Work in an evolving fast-paced environment where priorities shift, and new opportunities emerge regularly. 

Education

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

Work Experience

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

Preferred Knowledge, Skills and Abilities

• Hands on experience in some analytical techniques and familiarity with several techniques.   
• Experience with combination products/medical devices  
• Experience in analytical method development and validation and instrument qualifications in cGMP environment 
• Supervisory experience: Direct/Indirect Reports:  All levels of Analyst and Scientist 
• Functionality testing and chromatography, similar skills as identified 
• cGMP 
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description Ability to take initiative, to work efficiently to meet deadlines, and to work in a team environment are essential 
• 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 

Travel Requirements

Physical 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)