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Quality Control Specialist I or II- HPLC

2 months ago

Houston, United States PackGene Biotech, Inc. Full time

Mission Statement

The mission of PackGene Biotech is to accelerate gene therapy product development by providing an integrated one-stop shop solution to the gene therapy industry. We strive to make gene therapy accessible to more patients in need.

Gene therapy is believed to revolutionize the healthcare field in upcoming years. PackGene is well positioned to play a big role in this transformation.


Company Background

PackGene Biotech was founded in 2014 and headquartered in Guangzhou, China. It is a leading gene therapy CRO/CDMO service provider in Asia and is planning to start up its operations in Houston, TX.

PackGene is looking for a highly motivated hands-on individual to join our fast-growing Houston site. A fantastic opportunity to join a dynamic team and make a great impact


Requirements

The Quality Control Specialist I or II- HPLC will undertake laboratory work under the guidance of senior scientists. The Quality Control Specialist I or II is responsable to operate and maintain HPLC instruments; execute HPLC assays. The Quality Control Specialist I will have chance to learn Gene Therapy concepts and cGMP practice, etc.


Duties and Responsibilities

  • Conduct experiments under defined protocols under supervision of QC/AD scientist.
  • Routine lab activities may include:
  • Prepare solutions, buffers, and reagents.
  • Execute analytical assays on HPLC instruments. Perform HPLC instruments maintenance.
  • Effectively plan lab activities by ensuring equipment readiness and reagents availability.
  • Order lab reagents and suppliers and monitor expiry of critical raw materials.
  • Maintain an accurate sample inventory.
  • Record all data and results following good documentation practices.
  • Collaborate closely with cross functional teams to ensure timely receipt and testing of samples.
  • Coach and train staff as needed.
  • Maintain clean working lab environment.
  • Revise, format documentation and study reports.
  • All other duties as assigned


Skills and Qualifications

  • Bachelor's degree in bioscience, chemistry or related field
  • 1~2 years’ experience working with HPLC operation is preferred
  • Working knowledge of cell culture, AAV and experience with GxP-based laboratory setting and regulatory guidance is a plus
  • Strong interpersonal skills
  • Strong problem-solving abilities and drive for success
  • Excellent written and oral communication skills
  • High level of self-motivation
  • Keen attention to details
  • Extensive experience working in a team-oriented, collaborative environment


Physical Requirements

  • Crouching: Bending the body downward and forward by bending leg and spine.
  • Hearing: Perceiving the nature of sounds at normal speaking levels with or without correction and having the ability to receive detailed information through oral communication and making fine discriminations in sound.
  • Kneeling: Bending legs at knee to come to a rest on knee or knees.
  • Lifting: Raising objects of 25lbs from a lower to a higher position or moving objects horizontally from position to position. This factor is important if it occurs to a considerable degree and requires the substantial use of the upper extremities and back muscles.
  • Pulling: Using upper extremities to exert force in order to draw, drag, haul or tug objects in a sustained motion.
  • Pushing: Using upper extremities to press against something with steady force in order to thrust forward, downward or outward.
  • Reaching: Extending hand(s) and arm(s) in any direction.
  • Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers.
  • Sitting: Sitting for a period.
  • Standing: Remaining upright on the feet, particularly for sustained periods of time.
  • Stooping: Bending body downward and forward by bending spine at the waist.
  • Talking: Expressing or exchanging ideas by means of the spoken word; those activities where detailed or important spoken instructions must be conveyed to other workers accurately, loudly, or quickly.
  • Walking: Moving about on foot to accomplish tasks, particularly for long distances or moving from one work site to another.
  • The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication of parts at distances close to the eyes.