Senior Analytical Development Associate
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/or the Analytical Development Scientist and based in San Francisco, the Senior Development Associate will be responsible for designing, implementing, troubleshooting and documenting experiments in technical reports under minimum supervision. In addition, the candidate will be responsible for preparing and testing samples, and for interpreting, summarizing, documenting and communicating results. This position is a hands-on laboratory position focusing primarily on cell biology and immunology methods, as well as molecular biology methods such as qPCR.
The candidate will have a very good knowledge of FDA and ICH Guidelines including method qualification and validation requirements, and policies regarding reference standard and specification development.
Responsibilities include but are not limited to:
- Participating in technical transfer of assays into Analytical Development and into Process Development and contract laboratories.
- Conducting studies to support clinical programs, process development, and stability. The person must have documented experience in analytical assay development, instrument and method qualification/validation, technical transfer to QC, in a cGMP or GLP environment.
- Performing experimental work as part of assay development and/or qualification activities.
- Developing daily work plans, documenting experimental work, analyzing data and reporting results.
- Identifying problems, communicating them to the team, and developing solutions.
- Solving the majority of lab related problems that arise with little supervisory input.
- Working closely with overseas groups and contract labs to design, develop, transfer and qualify assays (some travel may be required).
- Summarizing, documenting and preparing data for databases and formal development reports and regulatory filings.
Qualifications:
- B.S. with 8+ years of related experience or M.S. with 5+ years of related experience in Cell Biology or Biochemistry or related scientific discipline.
- Strong foundation in experimental design, solid laboratory skills and ability to execute complex experiments.
- Experience with Immunoassays, cell based assay and cell culture is required.
- Experience in qPCR and molecular biology based assays is desirable.
- Experience with statistical data analysis
- Experience in assay qualification/validation in an industrial setting.
- Experience working with Quality Control.
- Excellent problem solver coupled with a strong work ethic is required.
- Ability to think in terms of day-to-day lab goals/activities and well as long-term project goals.
- Desire to learn new skills and grow his/her knowledge of assays and biological sciences.
- Ability to work independently as well as within teams sharing responsibilities and collaborating with strong team work attributes
- Experience in cancer biology, virology, cell biology, and immunology a plus.
- Excellent time management, technical writing, data presentation and communication skills.
- Experience working in a GLP/GMP or other regulated environment.
Specialized skills include:
- Cell-based assays
- Cell culture
- Immunoassay
- Molecular biology based methods a plus
- Virus infectivity assay with vaccinia a plus
- Method transfer
- Microsoft Office suite: Highly skilled in Excel, and proficient in Word, Outlook, Power Point.
- Other data management skills including statistical software such as Prism, PLA, etc. are desirable.
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.
