Research Site Research Associate (HPLC | AAV | Method Development) - San Diego, CA San Diego, California

Orbis Clinical is seeking a Research Associate (HPLC | AAV | Method Development) located in San Diego, CA for 6 months.

Job Title: Research Associate (HPLC | AAV | Method Development)

Location: San Diego, CA

Contract: 6 months

Summary:

Seeking an Analytical Development (AD) Research Associate with knowledge and hands-on experience in analytical and separations-based assays, as applied to AAV gene therapy products. The AD Senior Research Associate will be involved in supporting studies and method development from AD into Quality Control (QC). This individual will assist in routine analytics to support product- and process-related characterization. The role will assist to develop and perform analytical methods to support QC lot release and stability of company AAV Gene Therapy products.

Duties:

• Collaborate with research, quality control (QC), and process development teams to develop AAV gene therapy analytical methods for process monitoring and characterization under guidance of scientific mentor.
• Contribute to the development of robust separations-based methods (e.g. HPLC, UHPLC, CE-SDS, etc.) for drug substance and drug products.
• Participate in developing timelines, protocols, studies, and reports for method development and assay transfer.
• Author and review analytical / equipment logbooks, protocols, and reports as needed.
• Assist in timely execution of testing for routine in-process analytics, data review, and preparation of summary reports.
• May perform additional analytical development activities such as routine instrument maintenance / troubleshooting or quality-related exercises as needed.
• Maintain laboratory, support other AD divisions as needed, and ensure equipment is operational.
• Software Use Expectations:
  • Utilize Chromeleon CDS to acquire and process data.
  • Utilize statistical analysis software (e.g. JMP) to evaluate data, identify trends, and recommend assay acceptance criteria.

Requirements & Experience

• BS or equivalent in relevant discipline with a minimum of 2-5 years of relevant industry experience or Master’s degree in relevant discipline with a minimum of 0-2 years of relevant industry experience.
• Experience in pharmaceutical industry preferred, covering analytical method development and knowledge of QC testing.
• Strong, hands-on experience in HPLC and other separation-based technologies (e.g. CE-SDS) including knowledge of standard maintenance and troubleshooting.
• Willingness to take on new challenges required to bring novel medicines to the clinic.
• Excellent organizational and communication skills.
• Experience with Chromeleon CDS and JMP statistical software a plus.

Keywords: 

• ANALYTICAL METHOD DEVELOPMENT
• SEPARATIONS-BASED ASSAYS
• AAV GENE THERAPY
• QUALITY CONTROL TESTING
• HPLC

Additional

• CE-SDS
• INSTRUMENT MAINTENANCE
• INSTRUMENT TROUBLESHOOTING
• CHROMELEON CDS
• ORGANIZATIONAL SKILLS
• COMMUNICATION SKILLS
• EXPERIENCE IN PHARMACEUTICAL INDUSTRY
• JMP STATISTICAL SOFTWARE
• KNOWLEDGE OF QC TESTING
• EXPERIENCE WITH CHROMELEON CDS

Compensation Details:

• Orbis Clinical provides a reasonable range of compensation for our positions. Actual compensation is influenced by a wide array of factors including, but not limited to, skill set, level of experience and specific office location. 
• The Pay Range for this position is $45.00 – $55.00 per hour, can vary depending on employment status.
• Orbis Clinical offers eligible employees health benefits (medical, dental, and vision), employer-paid basic life and AD&D insurance, and a partial employer match on a 401(k). 

EEO and Reasonable Accommodation Statement:

Orbis Clinical provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, housing, age, disability or genetics.

We will consider all qualified applicants for employment, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state, and local laws.

By applying for this position, you agree that any calls from Orbis Clinical and its subsidiaries may be monitored or recorded for training and quality assurance purposes.