Analytical Lab Manager

2 weeks ago

South Plainfield, United States Medix™ Full time

Currently hiring for a Laboratory Manager with a strong analytical chemistry background with LC-MS and GC-MS. This opportunity is be joining a growing pharmaceutical manufacturer and have the opportunity to help build out the Analytical Chemistry department.


Roles & Responsibilities

  • Oversee the setup and day-to-day operations of the mass spectrometry (MS) lab within a cGMP-compliant environment. This includes managing workflows, personnel, and deliverables for LC-MS and GC-MS analyses of OTC drugs, dietary supplements, cosmetics, and Rx pharma products.
  • Develop and implement MS lab best practices, standard operating procedures (SOPs), work processes, and reporting templates. Ensure that all practices meet regulatory requirements and quality standards.
  • Create and validate mass spectrometry and chromatography parameters and methods for the quantitation of analytes using LC-MS and GC-MS. Write, review, and update SOPs and oversee method development and validation.
  • Act as the go-to expert for Scientech’s mass spectrometry, GC-MS, and LC-MS technologies. Provide guidance and expertise in these areas.
  • Train MS Lab Associates on new methods, instruments, and SOPs. Manage and oversee daily lab operations, ensuring timely and accurate delivery of results.
  • Identify and select the best vendors for equipment, reagents, and disposables. Install and set up LC-MS, GC-MS, and other MS lab capabilities.
  • Coordinate and support the installation, qualification (IQ/OQ/PQ), calibration, and maintenance of MS lab equipment and instrumentation.
  • Ensure the production of high-quality data for testing results across various MS methods and platforms. Conduct daily quality control reviews of MS lab results.
  • Represent the MS lab during internal, client, and regulatory body audits. Address any issues related to MS procedures, including out-of-specification (OOS) results and deviations.
  • Recruit, train, and manage MS Lab staff, including conducting annual performance reviews. Lead troubleshooting efforts for lab issues and manage investigations into OOS results.
  • Maintain and troubleshoot GC-MS, LC-MS, and other MS lab equipment as needed.


Requirements:

  • Education & Experience: PhD in Chemistry or related Life Sciences field preferred, with 5+ years of MS lab experience including significant management responsibilities. Experience in an FDA cGMP-regulated environment is highly preferred. Alternatively, an MS degree with 10+ years of experience, including 5+ years in a management role within a cGMP-regulated setting, will be considered.
  • Technical Expertise: Extensive experience with maintaining and troubleshooting a range of analytical lab instruments, including single quadrupole, triple quadrupole, and advanced MS systems interfaced with LC and GC platforms. Proficient in a variety of analytical services such as quantitation, potency testing, residual solvents, extractables & leachables, nitrosamines, pesticides, bioanalytical studies, pharmacokinetics, and metabolism studies.
  • Skills: Demonstrated ability to work independently, build programs and platforms, and solve complex problems. Proven track record of functioning well under high-stress conditions in a rapidly growing environment. Excellent interpersonal, communication, and leadership skills. Ability to prioritize tasks and adapt to a dynamic work environment.

  • Analytical Lab Manager

    3 weeks ago

    South Plainfield, United States Medix™ Full time

    Currently hiring for a Laboratory Manager with a strong analytical chemistry background with LC-MS and GC-MS. This opportunity is be joining a growing pharmaceutical manufacturer and have the opportunity to help build out the Analytical Chemistry department.Roles & ResponsibilitiesOversee the setup and day-to-day operations of the mass spectrometry (MS) lab...

  • Mass Spectrometry Lab Manager

    2 weeks ago

    South Plainfield, United States Riderflex Full time $120,000 - $150,000

    Job DescriptionJob Description Recruiting Firm, Riderflex has been hired by our client, Scientech Laboratories, in their search for a Mass Spectrometry Lab Manager. Company: Scientech Laboratories Industry: ResearchTitle: Mass Spectrometry Lab ManagerLocation: South Plainfield, NJReports To: Lab DirectorType: W-2 Full-TimeCompensation: $120,000 to...

  • Mass Spectrometry Lab Manager

    3 months ago

    South Plainfield, United States Medix™ Full time

    Roles & ResponsibilitiesBuild and manage the mass spectrometry (MS) lab, overseeing workflow, personnel, and deliverables in a cGMP-compliant analytical laboratory using LC-MS and GC-MS for testing OTC drugs, dietary supplements, cosmetics, and Rx Pharma products.Establish best practices, SOPs, work processes, workflow, and reporting templates for the MS...

  • Manager / Director of GMP Kilo Lab Operations

    1 day ago

    South Plainfield, United States Porton Pharma Solutions Ltd. Full time

    Job Title: Manager / Director of GMP Kilo Lab OperationsLocation: Onsite, South Plainfield, NJ Position Type: Full-Time Reports To: Sr. Director of GMP OperationsKey Responsibilities: Manage the Kilo Lab team and GMP Kilo lab operations to ensure high performance and adherence to GMP standards.Work with Process R&D chemists to ensure smooth technology...

  • Manager / Director of GMP Kilo Lab Operations

    23 hours ago

    South Plainfield, United States Porton Pharma Solutions Ltd. Full time

    Job Title: Manager / Director of GMP Kilo Lab OperationsLocation: Onsite, South Plainfield, NJ Position Type: Full-Time Reports To: Sr. Director of GMP OperationsKey Responsibilities: Manage the Kilo Lab team and GMP Kilo lab operations to ensure high performance and adherence to GMP standards.Work with Process R&D chemists to ensure smooth technology...

  • CSV(Lab System)

    4 weeks ago

    South Plainfield, United States Katalyst HealthCares & Life Sciences Full time

    The incumbent will be a part of the IT Computerized System Validation (CSV) Department and will perform and/or direct GxP computerized system validation projects in compliance with cGMP, CFR Part and Annex . This individual will ensure that GxP systems meet intended uses and comply with applicable regulations, current industry practices, and Revance's...

  • CSV(Lab System)

    2 weeks ago

    South Plainfield, United States Katalyst Healthcares and Life Sciences Full time

    The incumbent will be a part of the IT Computerized System Validation (CSV) Department and will perform and/or direct GxP computerized system validation projects in compliance with cGMP, 21 CFR Part 11 and Annex 11. This individual will ensure that GxP systems meet intended uses and comply with applicable regulations, current industry practices, and...

  • Lab Systems Validation Specialist

    1 week ago

    South Plainfield, New Jersey, United States Katalyst HealthCares & Life Sciences Full time

    The selected candidate will be an integral part of the IT Computerized System Validation (CSV) Division, overseeing and executing GxP computerized system validation initiatives in alignment with cGMP, CFR Part, and Annex regulations. This role is crucial in ensuring that GxP systems fulfill their intended purposes and adhere to relevant regulations,...

  • Lab Technician

    1 month ago

    Plainfield, United States Russell Tobin & Associates Full time

    What are we looking for in our Lab Technician ? Russell Tobin's client, a global leading beverage alcohol company is seeking a Lab Technician in Plainfield, IL The LAB Technician is responsible for ensuring that production maintains the established standards and quality control systems outlined by Client to safely produce quality cases of...

  • Lab Technician

    4 weeks ago

    Plainfield, United States RTA US Full time

    Job DescriptionJob DescriptionRussell Tobin's client, a global leading beverage alcohol company is seeking a Lab Technician in Plainfield, ILThe LAB Technician is responsible for ensuring that production maintains the established standards and quality control systems outlined by Client to safely produce quality cases of our various distilled products...

  • Lab Systems Validation Specialist

    1 week ago

    South Plainfield, New Jersey, United States Katalyst HealthCares & Life Sciences Full time

    The selected candidate will be an integral part of the IT Computerized System Validation (CSV) Department, overseeing and executing GxP computerized system validation initiatives in alignment with current Good Manufacturing Practices (cGMP), applicable regulations, and industry standards. This role is crucial in ensuring that GxP systems fulfill their...

  • Lab Systems Validation Specialist

    2 weeks ago

    South Plainfield, New Jersey, United States Katalyst HealthCares & Life Sciences Full time

    The selected candidate will be an integral part of the IT Computerized System Validation (CSV) Division, overseeing and executing GxP computerized system validation initiatives in accordance with cGMP, CFR Part, and Annex regulations. This role is crucial in ensuring that GxP systems fulfill their intended purposes and adhere to relevant regulations,...

  • Lab Technician, Molecular Biology 11am-7:30pm

    1 month ago

    South Plainfield, United States Azenta Life Sciences Full time

    Job DescriptionJob DescriptionPosition Title: Laboratory Technician ILocation: South Plainfield, NJShift: Mon-Fri 11:00am-7:30pm IntroAt Azenta, new ideas, new technologies and new ways of thinking are driving our future. Our customer-focused culture encourages employees to embrace innovation and challenge the status quo with novel thinking and...

  • Lab Technician, Sanger Sequencing 7:30pm-4am

    3 months ago

    South Plainfield, United States Azenta Life Sciences Full time

    Job DescriptionJob DescriptionJob DescriptionPosition Title: Laboratory Technician ILocation: South Plainfield, NJShift: Mon-Fri 7:30pm-4am IntroAt Azenta, new ideas, new technologies and new ways of thinking are driving our future. Our customer-focused culture encourages employees to embrace innovation and challenge the status quo with novel thinking and...

  • Dir/Assoc. Dir, Clinical Analytics

    3 weeks ago

    South San Francisco, United States Vaxart, Inc. Full time

    Summary: The Director/Associate Director, Clinical Analytics position will provide oversight of GCP analytical operations to support Vaxart’s clinical trials.  Responsibilities will encompass oversight of clinical assays conducted to support early-stage Phase 1/2 trials including immunoassay optimization and execution as well as managing data transfer...

  • Lead Analytical Chemist

    6 days ago

    South San Francisco, California, United States Addison Group Full time

    About the RoleWe are seeking a highly skilled Senior Analytical Scientist to join our team at Addison Group. As a key member of our analytical team, you will be responsible for designing and executing experiments to fully characterize oligonucleotide drug substances and drug product materials.Key ResponsibilitiesExperiment Design and Execution: Design and...

  • Quality Assurance Associate II

    1 month ago

    South Plainfield, United States Riderflex Full time

    Job DescriptionJob DescriptionRecruiting Firm Riderflex has been hired by our client, Scientech Laboratories, in their search for a Quality Assurance Associate II. Company: Scientech Laboratories Industry: ResearchTitle: Quality Assurance AssociateLocation: South Plainfield, NJReports To: Quality Assurance SupervisorType: W-2 Full-TimePosition...

  • Senior Manager, Analytical Development and Quality Control

    4 weeks ago

    South San Francisco, California, United States pliant-therapeutic Full time

    Pliant Therapeutics is a late-stage biopharmaceutical company focused on the discovery and development of novel therapies for fibrotic diseases. Founded by Third Rock Ventures with world-renowned academic thought leaders, Pliant is raising the bar to meet the unmet medical needs of physicians, patients and families impacted by fibrotic diseases. As the...

  • Quality Management Specialist

    1 day ago

    South Plainfield, New Jersey, United States Katalyst Healthcares & Life Sciences Full time

    About the Role:Katalyst Healthcares & Life Sciences is seeking a highly experienced Quality Management Specialist to join our team. As a Quality Management Specialist, you will be responsible for developing and implementing quality management systems and methodologies to ensure the highest level of product quality.Key Responsibilities:Develop and Implement...

  • WA-Medical Laboratory Scientist or Medical Lab Technician

    3 weeks ago

    South Bend, United States V R Della Infotech Inc Full time

    Job DescriptionJob DescriptionMedical Lab Scientist or Medical Lab Technician This is a union position, not salaried, but hourly. Medical Laboratory Scientist -wage is based on experience- Wage range BR- BR. (Annualized Salary listed below)Medical Lab Technician -wage based on experience- Wage range BR-BR (Annualized Salary not listed) Has professional...