Analytical Lab Manager

4 weeks ago

Miami, United States Meds.com Full time

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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