Lab Operations Specialist

1 month ago

Gaithersburg, United States Global Solutions Network Inc. Full time

Global Solutions Network (GSN), a federal government contracting firm, presents this full time, long-term position supporting GSN's customer at the National Institutes of Health (NIH). This position provides a competitive salary and comprehensive benefits.

If interested, please provide an up-to-date resume.

Responsibilities.

  • Prepare Vaccine Production Program (VPP) biological buffers and bulk drug candidate products for laboratory inventory in support of development and production of government vaccine and biotherapeutic investigational products, including, but not limited to:
    • Maintain communication with the VPP process groups to ensure the process groups have the buffers which are needed for processing ahead of time.
    • Obtain purified bulk vaccine candidates/biotherapeutics or bioreagents from the VPP downstream group.
    • Verify all label information on the bulk from downstream is correct.
    • With guidance, determine the aliquoting plan for each lot of bulk received per direction of the scientific operations manager for VPP.
    • Generate the correct number of labels per container size for each lot.
    • Perform the aseptic aliquoting for each lot of bulk in a biological safety cabinet.
    • Determine the storage location for each aliquoted lot (-80C, -30C, or 4C) as specified by either the scientific operations manager or the project manager for the VPP.
    • Prepare products for shipment to outside collaborators, following all NIH/IATA/DOT regulations.
  • Develop, implement, and follow departmental policies related to primary duties and other aspects of VPP Scientific Operations as needed.
  • Maintain consumable inventory stock for VPP processes.
  • Aid in the processing of laboratory requests for commercially available goods (CAG) from VPP stockroom or equivalent.
  • Aid in SDS database under the direction of the VPP SOM or designee.
  • Perform weekly verification of CAG held by VPP Scientific Operations and notify the VPP SOM or designee.
  • Aid in response to departmental requests for instrument service, under the direction of the VPP SOM or designee.
  • Follow established departmental policies, procedures, and objectives, continuous quality improvement objectives, and safety, environmental, and/or infection control standards.
  • Aid SME in QA responsibilities including but not limited to laboratory notebook issuance/retention, review, and audits.
  • Serve as a backup emergency responder for all VPP REES (alarm system) monitored equipment.
  • Operate dolly/ pallet jack in loading and unloading supplies and equipment.
  • Perform miscellaneous job-related duties as assigned by either the Scientific Operations Manager, the VPP Materials and Documentation Control Manager, or the Senior Scientific Associate for Materials, including but not limited to performance of property checks, maintenance of service contracts on lab equipment, monitoring commercially available goods, biological/chemical waste removal, equipment moving, package delivery and various inventory levels.
Qualifications.
  • Bachelor's degree in Biology, Chemistry, or related field with minimum 5 years of experience in a research laboratory setting (not medical or hospital lab).
  • Experience in Laboratory information Systems.
  • Experience in Microsoft Office, especially Excel and Word.
  • Strong knowledge of scientific/biotechnology laboratory documentation requirements (GDP).
  • Strong analytical capabilities to prepare inventory analytics and other metrics.
  • Strong communication skills to communicate to internal and external stakeholders.
  • Must have the ability to work as a team member.
  • Experience in working with Aseptic and biological safety cabinet (BSC)
  • Preferred: 2 yrs experience working in a biological safety cabinet and a laminar flow hood.
  • Preferred: 2 year of demonstrated experience/training in sterile technique for handling biological products.
  • Preferred: Hands-on experience with product candidate inventory management systems.
  • Preferred: current up to date training in USDOT and IATA training for biological shipping.
  • Preferred: Experience with SmartSheet, (LIMS), and electronic laboratory notebooks (ELNs).
  • Preferred: current training in RCRA, DOT and Hazcom (GHS).
Benefits.
  • Medical, Dental, & Vision Coverage
  • Paid Time Off and Paid Holidays
  • 401K/Profit Sharing Plan
  • Flexible Spending Accounts (Healthcare & Dependent Care)
  • Pretax Parking & Transportation Plan
  • Short-Term & Long-Term Disability Insurance
  • Life & AD&D Insurance
  • Professional Development/Education
  • Employee Referral Bonuses
  • Employee Discount Program
  • Merit Bonuses
  • Employee Assistance Program
  • Travel Assistance Program

Global Solutions Network, Inc. (GSN) is an Equal Employment Opportunity (EEO) employer. It is the policy of the GSN to provide equal employment opportunities to all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected US veteran or disabled status, or genetic information.

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