Analytical Development Expert

Location Texas
Discipline: Pre-Clinical Development
Job type: Permanent
Salary: £Salary: On application
Contact name: Surbhi Dhar

Contact email: surbhi.dhar@rbwconsulting.com
Contact phone: 16179821238
Job ref: ​21707
Published: 22 days ago
Expiry date: 28 June 2021

Reports to: Director, Analytical Development and QC

Classification: Full-Time /Exempt /Salaried

Company: We have made a commitment to helping people with rare and devastating diseases who have limited treatment avenues. Our pipeline of novel therapies can modulate chemical imbalances behind the disease. We use our enzymatic engineering expertise to develop treatments that improve lives today and create a better tomorrow.

Position Summary: Located in Austin, Texas, we are looking for an experienced protein analytical development scientist/chemist to develop methods to test the purity, stability, activity and identity of assays for drug substance and products. The position will be reporting to the Director of Analytical Development and QC. and will develop analytical methods towards release and characterization of protein biologics (especially enzymes). The role will sit within the Analytical and QC team within the company and supporting cross functional teams.

Responsibilities:

  • Carry out optimization, assessments and method development to test and release drug products and drug substances

  • Be the subject matter expert on all aspects of analytical development, especially for protein biologics

  • Apply expertise to troubleshoot any issues within analytical method development

  • Collaborate with the Process Development team and execute analytical studies

  • Write methods, protocols and reports

  • Analyze and interpret data to feed towards selection of appropriate approaches that support lead candidates to go from early phases to downstream CMC needs

  • Collaborate with external partners for analytical testing

Requirements:

  • BS or MS with 8-10 years or PhD with 5 years of relevant experience, preferably in an industry setting.

  • Experience with protein biologics, preferably enzymes

  • Experience with a broad range of analytical technologies, especially liquid chromatography (HPLC/UPLC) and electrophoretic methods (capillary electrophoresis)

  • Strong knowledge of protein biochemistry with some experience in LC-MS and mass spectrometric optimization of proteins

  • Ability to develop and optimize analytical methods and assays for biologics independently

  • Past experience with analytical method development for large molecules in an industry setting

  • Good understanding of analytical CMC and regulatory requirements for biologics product development

  • Ability to write reports and articulate data for regulatory filings and presentations

  • Strong verbal and written skills and ability to listens to others, and provide constructive feedback

Work Environment:

This is a high growth, fast paced, and small organization. The ability to be productive and successful in a scientifically led and data driven work environment is critical. Willingness and ability to travel domestically and internationally on occasion is required, it is anticipated that this will be less than 10% of work time.

Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Light physical activity performing non-strenuous daily activities of an administrative nature. Including but not limited to: Sitting for greater than 75% of your time, standing and walking for up to 25% of your time. Manual dexterity sufficient to reach/handle items and work with the fingers. Use of hands to fingers for typing and other computer activity for up to 75% of your time. Reaching with hands and arms, climb or balance, stoop, kneel, crouch, or crawl less than 25% of your time. Ability to lift, up to 25lbs, less than 25% of the time.

Salary: On application