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.