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Job Description

Research Associate will be responsible for developing assays for the GMP release of drug substances and drug products, mostly using HPLC, and may work on Capillary Electrophoresis, AUC and Mass Spectrometry. Maintain a well- documented record of activities in ELN and reports. Summarize and present experimental results in meetings and responsible for report and SOP writing. The position level will be commensurate with education and experience level. This role will be at our South San Francisco R&D facility.

Job Description

Research Associate will be responsible for developing assays for the GMP release of drug substances and drug products, mostly using HPLC, and may work on Capillary Electrophoresis, AUC and Mass Spectrometry. Maintain a well- documented record of activities in ELN and reports. Summarize and present experimental results in meetings and responsible for report and SOP writing. The position level will be commensurate with education and experience level. This role will be at our South San Francisco R&D facility.

Responsibilities

• Develop assays for GMP release of gene therapy products
• Develop assays for product characterization of gene therapy products
• Develop assays for AAV/protein/DNA and other materials to assist in evaluation of process change, formulation and stability study
• Report project status (development plans, timelines, and results) to supervisor and technical teams.
• Write SOP, tech transfer and development reports.
• Keep current with all regulatory guidelines, compendia requirements, and technical innovations.
• Maintain accurate, error-free records of all analytical development activities timely
  
  

Required Qualifications

• Bachelor of Science with 3+ years, or Masters of Science with 1+ years experience in biopharma industry with proven expertise of a range of physicochemical methodologies for quantifying purity/quality of proteins, viruses, and viral vectors
• Extensive experience and knowledge in operating HPLC applied to DNA/RNA, proteins, polymers, detergent and/or viral vectors.
• Positive, professional self-starter with a passion for science, innovative technical and analytical skills required to perform at the highest level
• Highly motivated and independent yet has successfully worked in a group setting with efficient, flexible and self-motivated work ethic; to be utilized in work planning, executing, and data analyzing.
• Excellent clear and concise writing skills for technical reports and documents along with strong verbal communication skills
• Proven ability to work in cross-functional teams as a strong team player as well as independently.
• Successful history and the ability to handle several fast-paced projects concurrently.
• Excellent communication, writing and presentation skills to technical and non-technical audiences.
• Proficient working in Microsoft Office Suite
  
  

Preferred

• 5+ years of HPLC usage and troubleshooting
• Experience in analytical method development and separation technologies including multiple modes such as capillary electrophoresis, AUC and mass spectrometric is preferred
• Prior experience with AAV or other virus is preferred.
  
  

Pay Rate Range: $30-40/hr depending on experience
The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

• Industries

  Staffing and Recruiting

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