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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.
The Company is an equal opportunity employer and makes employment decisions on the basis of merit. The Company prohibits unlawful discrimination on the basis of race, color, national origin, ancestry, religion, creed, age, sex, sexual orientation, gender identity, pregnancy, marital status, physical or mental disability, medical condition or any other consideration made unlawful by federal, state or local laws. The Company will also provide reasonable accommodation to the known physical or mental disability of an otherwise qualified employee or applicant. Should you need any such accommodation, please contact the Company for further information. The Company is dedicated to ensuring that all decisions regarding personnel are in accordance with all applicable laws. I certify that all statements made in this application are true to the best of my knowledge. I understand that all falsification or misleading information given in my application may result in the termination of my employment with Orbis Clinical and its subsidiaries. Furthermore, I understand that my professional conduct and clinical performance is directly related to my ability to be placed on assignments for Orbis Clinical and that I will adhere to all regulations and guidelines of Orbis Clinical. I authorization Orbis Clinical to verify the information I have provided, to contact references, and to conduct criminal, education and personal background checks concerning my qualifications, and past employment record. I understand that nothing contained in this application is intended to create an employment contract, either verbal or written, with Orbis Clinical or its clients. Furthermore, I understand that my employment, it is “at will” and Orbis Clinical or I may terminate my employment at any time with or without notice and with or without case. I acknowledge that I will be legally obligated by the terms of this document by typing my name, which will constitute my signature, or manually signing, in the provided space and electronically transmitting this document to Orbis Clinical. I agree that Orbis Clinical and I may use electronic means to conduct this transaction and that this document shall be governed and construed by the laws of the State of Massachusetts.
