Scientist I, Analytical Development

Theradaptive is revolutionizing the field of therapeutic delivery with a pipeline of best-in-class products that address multiple global markets. Theradaptive is performing cutting edge science in the area of regenerative medicine, working at the interface of Biology and Orthopedic tissue repair.

Our lead therapeutics are in the following indications:

  • Spinal Fusion
  • Long Bone Repair
  • Osteochondral Repair
  • Dental and Facial Bone Repair
  • Immuno-Oncology

We are an innovative, fast-paced team that is advancing a diverse array of cutting-edge translational research projects.

 

POSITION SUMMARY:

 

We are seeking a talented Analytical Development Scientist I to join our team. The ideal candidate will play a key role in developing, troubleshooting, and conducting assays using chromatography, electrophoresis, and immunoassay techniques. These assays are crucial in supporting the development, manufacturing, and characterization of Biologic Drug Substances and Drug Product/Medical Devices.

The candidate will be expected to make detailed experimental observations, analyzing data, interpreting experimental results, and summarizing findings for presentations and reports. Additionally, the successful candidate will have the opportunity to contribute to the authoring and revision of SOPs, protocols, technical reports, and other relevant documentation.

 

RESPONSIBILITIES:

  • Develop and optimize analytical methods using Chromatography (SEC, IEC, RPLC) and/or electrophoresis (cIEF, CE-SDS) techniques for the release and characterization of biologics and drug product/medical devices.
  • Design and execute laboratory experiments (sample testing) to characterize biologics using HPLC, cIEF, CE-SDS and/or immunoassays and cell based- assays.
  • Author and review method development reports, method qualification study protocols and qualification study reports
  • Perform sample testing, analyze, interpret and report results in appropriate formats including ELN, formal report, and presentation.
  • Author and reviews SOPs for test method procedure and laboratory equipment operation and maintenance.
  • Ensure proper qualification, calibration, and maintenance of laboratory equipment in accordance with established schedules.
  • Adhere to cGMP requirements as needed and uphold compliance with standard operating procedures to maintain quality standards.
  • Undertake any additional duties and responsibilities as needed to support the objectives of the laboratory.
  • Working knowledge of statistical analysis software is a plus.

QUALIFICATIONS:

  • PhD, MS. or BS degree in Biochemistry, Pharmaceutical Analysis, Biotechnology, or Analytical Chemistry.
  • BS degree with 5+ years or MS with 3+ or PhD with 1+ years of industry laboratory experience.
  • Hands on experience on Chromatography (SEC, IEC, RPLC) and/or electrophoresis (cIEF, CE-SDS) and/or immunoassays and cell-based assays.
  • Experience in developing and qualifying analytical methods for biologics is considered advantageous.
  • Strong multi-tasking abilities, effective time management skills, and excellent organizational capabilities are required.
  • Ability to work collaboratively in a team environment, meticulous attention to detail, and exceptional verbal and written communication skills are essential.

PHYSICAL DEMANDS:

  • Ability to work in a laboratory and office setting.
  • Ability to lift up to 40 lbs.
  • Ability to work in a laboratory with chemicals and biochemicals and perform Biosafety Level 2 work.

POSITION LOCATION:

  • Theradaptive corporate headquarters and laboratory in Frederick, MD.

https://www.theradaptive.com 

Theradaptive is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, ethnic or national origin, ancestry, pregnancy (including childbirth or related condition), citizenship, familial status, mental or physical disability, veteran status, genetic information, other non-disqualifying disability, or any other characteristic protected by law.