SCIENTIST - CELL THERAPY ANALYTICS
******** is developing a next generation manufacturing process to advance our platform of immune cell products. We are currently seeking an individual for our Viral Vector group as we advance our production platforms. The position offers a chance to be part of a highly motivated team, applying the latest cell culture and bioprocessing practices to facilitate development of our proprietary cell therapies.
We are currently seeking an energetic and experienced Senior or Principal Scientist with a strong background in viral vector production to oversee process development, scale-up, and technology transfer for vector programs.
The individual will serve as a program lead reporting to the Director of Viral Vector Development and will work in collaboration with the Downstream and Analytical Development leads, as well as other cross-functional teams, to develop a best-in-class vector manufacturing process. The successful candidate will guide development programs for vector generation, media/cell culture optimization for viral vector production platforms, cell-line generation and development, and other aspects of viral vector production. This person will also work with other Technical Operations teams and external groups in order to align on goals, meet project timelines, and deliver a consistent and robust viral vector product.
Additional job responsibilities:
* Independently lead, design, and help execute the upstream process development, and characterization of viral vectors in adherent and suspension culture platforms.
* Facilitate collaboration with Viral Vector Upstream and Downstream scientific staffs.
* Design and oversee optimization of critical scientific and engineering parameters for the upstream process of retroviral vector production including optimal cell culture conditions, media development, and harvest in both adherent and suspension platforms.
* Serve as an SME for upstream viral vector applications, and data interpretation when communicating with external groups and providing technical support to manufacturing and CMOs.
* Drafting and editing of standard operating procedures, sampling plans, technical documents, and batch records for successful regulatory filings or tech transfer purposes.
* Source and assess new equipment and technologies to expand and improve upstream culturing and viral vector production capabilities.
* Coordinate continued development of suspension culture processes in shake flasks and stirred-tank bioreactors.
* Identify risks and develop mitigation plans in the upstream process development and enable quick and robust decision making through efficient collaboration.
* Provide leadership and mentor junior and senior scientific staff.
Upstream Viral Vector Development - Qualifications:
* Education, Experience, and Skills Requirements
* Advanced degree with a background in biology, biomedical engineering, biochemistry, cell & molecular biology, or related life science field is required. Doctoral degree or master's degree with 2+ years or 4+ years post-graduate experience, respectively. Candidates with previous experience in cell or gene therapy will be given preference.
* Considerable direct experience with viral vector production applications is required.
* Experience in working in a BSL-2 environment is required.
* Previous experience with suspension cultures using stirred-tank bioreactor systems (e.g. single-use bioreactors) to manufacture viral vectors is required.
* Demonstrated competency and experience with viral vector upstream production, aseptic processing, process development, process qualification/validation and technology transfer for GMP production.
* Previous experience managing and mentoring junior scientific staff.
* Candidates having prior experience with cell line development or media optimization will be given strongest preference.
* Familiarity with current principles and technical platforms for monitoring cell growth, viability, metabolism, etc., is expected.
* Previous experience conducting technology transfers to external CMOs or adapting client-derived upstream process as a part of a CMO is desirable.
* Experience in authoring SOPs and contributing to CMC sections of regulatory filings is desired
* Familiarity with factorial experimental design and DOE software (JMP, Design-Expert, etc.) is desired.
All workers are required to be fully vaccinated against COVID-19, including the booster dose.
We offer both comprehensive benefits and Paid Time (PTO) plans for employees, which begin on the first day of employment, as well as the opportunity to work in a growing, dynamic environment.