Analytical Lab Manager

Overview

We are a fast-growing healthcare technology company seeking an experienced Analytical Lab Manager who has previous experience spearheading the buildout of a new lab from the ground up and is ready to do it again, as well as support continuous operations thereafter.

The ideal candidate will be based in/near Fort Lauderdale, FL and would be comfortable traveling on an as-needed to basis to pre-existing locations, including but not limited to the Chicago, IL area, where you will initially help develop an internal lab practice while simultaneously building out a new lab from scratch in Florida.

Lab testing services will include API analysis, as well as pharmaceutical R&D functions.

Responsibilities And Duties

SOP Development:

Develop SOPs, guidance, protocols, and reports that meet requirements of GMP and appropriate regulatory guidelines.

Workflow Enhancement:

• Develop and validate analytical methods for testing raw material and formulated pharmaceutical products in solid and liquid oral dosage forms
• Perform analytical testing using established in-house and USP analytical methods
  
  

Manage the day-to-day activities for all R&D method development, transfer, validation, early-phase formulation development, and finished product testing, including:

• Assay, related substances, impurities, uniformity of dosage units, dissolution, residua solvents, loss-on-drying, microbial testing, cleaning verification and validation
• Container/closure testing and selection
• Conduct stability-indicating studies per USP and ICH guidelines
• Perform installation qualification, operational and performance qualification for new instrumentation
  
  

Strategic Vision:

• Spearhead both short- and long-term strategic planning for lab space, infrastructure, and data accessibility
• Facilitate the evaluation of new testing applications and instrumentation. Assist in the purchase and commission of analytical instrumentation
• Provide guidance to resolve problems with instruments, test methods, lab chemicals, standards, and samples
• Stay current on publications released by USP, FDA, and other pertinent regulating bodies to ensure activities throughout the facility are compliant and continuously improved upon
  
  

Contract Service Strategy:

• Formulate a comprehensive lab contract service strategy and establish agreements
  
  

Budget Oversight:

• Manage budgets for service contracts, repairs, and equipment maintenance
• Implement efficient planning and scheduling to minimize equipment disruption
• Oversee asset life-cycle management with attention to budget efficiency
  
  

Staff Training and Competency:

• Conduct thorough staff training and ensure the certification of competency
• Supervise work processes to guarantee precision and efficiency
  
  

Sample Management:

• Ensure meticulous handling of testing samples from receipt to organization and preparation
• Address initial troubleshooting of testing issues and report problems promptly to leadership
  
  

QA/QC Compliance:

• Ensure unwavering adherence to all QA/QC protocols and validate compliance
• Responsible for investigating and processing Deviations, Out-of-Specifications, Out-of-Trend, and QC events
• Possess a deep understanding of ISO 17025 standards, 21 CFR, US FDA guidance, ICH guidelines, and compendia requirements
  
  

Scientific Supplies Management:

• Assist in developing and executing the best laboratory operations plan with a focus on scientific supplies management
  
  

Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, or equivalent
• At least 3-5 years of hands-on experience in biotech/pharmaceutical laboratories
• At least 3-5 years of theoretical and hands-on experience in various analytical techniques and instrumentations (HPLC, LCMS) for analytical development
• Previous experience in a licensed analytical product testing laboratory is highly desirable
• A collaborative team player with strong communication and interpersonal skills who is also comfortable working independently
• Excellent attention to detail and ability to maintain a high level of accuracy, while meeting deadlines for assigned projects
• Able to multi-task, prioritize and manage timelines in a fast-paced environment
• Must be able to lift at least 50 lbs
  
  

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