SR. PROCESS DEVELOPMENT ASSOCIATE - UPSTREAM
General Job Description:
This position is located within the Process Development department and is responsible for developing GMP cell lines that facilitate the progressing of GenVivo’s cutting edge science derived gene therapy based therapeutics into clinical trials. As a Senior Development Associate, the candidate will be a key contributor to refining our approaches used currently in the cell line development workflow, as well as developing next generation in-house cell line fed-batch screening and production processes. In addition, the candidate will provide oversight for cell line development activities for pipeline projects. The position requires in-depth knowledge of cell culture process and media development, and experience in construction of mammalian cell lines suitable for GMP manufacturing.
GenVivo’s mission is to pioneer innovative gene therapies for administration to cancer patients in order to improve patient survival and ultimately to make patients cancer free. Our approach to synergistically kill tumors while activating the immune system to fight the patient’s cancer combined with the integration of novel companion diagnostics, positions us on the cutting edge of cancer immunotherapies and emerging clinical stage cancer companies. We are an ambitious, growing company whose employees are enthusiastic and passionate, respectful of each other, and highly committed to our mission and values. The company thrives on collaboration and since we are currently small, every individual and each idea is important and counts.
Primary Duties and Responsibilities (include but are not limited to):
- Responsible for coordinating and managing the activities in pipeline projects involving development of GMP cell lines
- Perform media component analysis and development studies to select suitable conditions for both cell line screening and cell culture processes
- Provide technical oversight in upstream related activities including process development and process transfer
- Hands on execution of cell line development activities for pipeline projects
- Contribute to the improvements of current cell line development platform and to the development of a new cell line and cell culture platform
- Design studies and interpret results of development, troubleshooting and process characterization experiments
- Author and review protocols, technical reports, batch records, SOPs and CMC sections of regulatory submissions
- Conduct root cause investigations and identify solutions to resolve upstream and media development related issues
- Represent the upstream functional area within the CMC team; communicate and collaborate with members from CMC, QA, Regulatory Affairs, Clinical Development to achieve project goals and timelines
- The position requires close collaboration with other CMC functions. Work together with Upstream, Downstream, and QA/QC areas, including providing data and materials to support efforts in Upstream, Downstream, and QA/QC
The ideal candidate will have:
- BS or greater with 5+ years of biopharmaceutical industry experience or equivalent
- Experience in development and execution of mammalian cell culture processes
- Experience in harvest, clarification, and recovery processes is a plus
- Knowledge of cGMP and regulatory requirements related to biologics manufacturing and controls
- Extremely detail-oriented and diligent in experimental design, data analysis and review
- High level of motivation and initiative
- Excellent written and verbal communication skills
- Work well in a dynamic, high energy, fast-paced team and collaborate with cross-functional groups
- Must demonstrate hands-on technical proficiency and independently conduct experiments and present work
- Demonstrate ability to effectively and collaboratively work in cross-functional teams, meet deadlines, and prioritize multiple activities
- Professional integrity and maturity with high degree of discretion dealing with confidential information
- Ability and willingness to work flexible hours when necessaryMust be eligible to work in the U.S.
NO PHONE CALLS PLEASE AND NO AGENCIES OR RECRUITERS.