Analytical Development Scientist
Jennerex, Inc. is a clinical-stage biotherapeutics company focused on the development and commercialization of first-in-class, breakthrough targeted oncolytic products for cancer. Jennerex is headquartered in San Francisco and has related research and development operations in Ottawa, Canada and Pusan, South Korea. For more information about Jennerex, please visit www.jennerex.com.
Position Description
Reporting to the Director of Analytical Development and based in San Francisco, the Analytical Development Scientist will be responsible for analytical assay development activities for Jennerex's new and existing products. This position is a hands-on laboratory position requiring a strong focus in molecular biology methods such as qPCR.
Responsibilities include but are not limited to:
- Designing, implementing, troubleshooting and documenting experiments, and writing development reports. In addition, preparing and testing development samples, interpreting, summarizing, documenting and communicating results.
- Managing technical transfer of assays into Analytical Development and into Process Development and contract laboratories. In addition, designing and executing stand-alone studies to support clinical programs, process development, and stability. This requires documented experience in analytical assay development, instrument and method qualification, and technical transfer, in a cGMP or GLP environment.
- Learning to develop project strategy in consultation with supervisor.
- Solving the majority of lab related problems that arise with little supervisory input.
- Working closely with overseas groups to design, develop, troubleshoot, transfer and qualify assays (some travel may be required).
- Reviewing, summarizing, documenting and preparing data for databases and formal reports.
- Writing technical development reports to support analytical development and regulatory filings.
- Exposure to and involvement in a wide spectrum of R&D and QC functions.
Qualifications:
- PhD in relevant field with 2-5 years of industry experience in assay development (M.S. or B.S. with extended experience will be considered).
- Experience in molecular biology required. In-depth knowledge of qPCR is highly desirable
- Experience in assay qualification/validation in an industrial setting.
- Experience in cancer biology, virology, cell biology, and immunology a plus.
- Excellent analytical, technical writing, communication and data management skills.
- Experience working in a GLP/GMP or other regulated environment is desirable.
- Ability to work independently, and multitask under aggressive timelines to support department and corporate objectives.
- Strong knowledge of FDA and ICH Guidelines including method qualification and validation requirements, and policies regarding reference standard and specification development.
- Ability to think in terms of day-to-day lab goals/activities as well as long-term project goals.
Specialized skills include:
- qPCR and other molecular biology based assays
- Virus infectivity assays, especially with Vaccinia
- Cell-based assays, a plus
- Immunoassay, a plus
- Method transfer
- Microsoft Office suite: Highly skilled in Excel, and proficient in Word, Outlook, Power Point.
- Other data management skills including the use statistical software such as Prism, etc. are desirable.
Supervison:
Minimum supervision required on day-to-day activities and accomplished tasks. May have formal supervisory responsibilities, in which case the individual must:- Create goals and development plans for direct reports
- Responsible for teaching, guiding, mentoring direct report(s)
- Responsible for overseeing the activities of direct reports and ensuring tasks are accomplished in accordance with department and business priorities
Salary:
Competitive compensation package commensurate with experience
Please submit your resume to: HR@Jennerex.com
Your resume is very important to us. In order to process your resume in the most efficient manner possible, Jennerex strongly encourages you to apply online. It is not necessary to send a back-up hard copy resume. Thank you for your cooperation with our process and, most importantly, your interest in Jennerex.
