: Sr. Upstream Scientist
Develop robust, high-yield and scalable production processes for both mammalian cell culture and microbial fermentation based biologic product candidates.
Develop and characterize CHO/HEK/Vero cell based cell lines, evaluate cell line stability and suitability for large scale GMP manufacture.
Develop, optimize and scale-up fed-batch and continuous processes using Sartorius B-DCUII small glass bioreactors and BIOSTAT CultiBag STR single-use bioreactors at 2L, 10L, 50L, and 200L scales. Lead efforts to evaluate different cell culture medium formulations and optimal feeding strategies to improve product yield in shaker flask and small scale bioreactors.
Operate NBS Bioflo310 to perform fermentation culture production.
Interacts with other departments involved in GMP manufacturing for planning production, testing and product release in a timely manner resulting in successful completion of projects.
Participate in technology transfer of processes to Manufacturing from external clients, and from internal process Development to Manufacturing.
Generate, manage, and maintain critical methods and data in a highly organized manner. Provide progress and developmental reports for assessment by clients.
Develop and draft production batch records for GMP manufacturing, support and troubleshooting GMP production activities.
Perform experiments and deliver results under minimal supervision, and within tight time lines including weekend working schedules, to a prescribed objective and budget for internal / external client projects.
Maintain and calibrate the critical equipment for intended use. Identify and order the critical raw materials and reagents per specific client project to meet the specification.
KNOWLEDGE AND EXPERIENCE REQUIRED
This position requires an MS degree with 4-7 years or BS degree with over 7 years of experience in upstream process and cell line development area. Experience with cGMP Manufacturing under cGMP compliance is a plus.
Must be able to lift up to 50 lbs with or without reasonable accommodations.
Intermediate computer skills using MS Office (Word, Excel, PowerPoint) preferred.
Possess excellent interpersonal skills, both communication and written.
Task and Team-oriented, analytical, organized, detail-oriented, self-motivated and ability to multi-task.
Candidate must meet all the requirements of our Company Occupational Health program as directed by the Occupational Health Consultant to include pre-employment physical and drug screen.
Candidates are encouraged to submit a resume and a cover letter outlining background and experience as it relates to the position requirements and salary history/requirements. Please note that “negotiable” is neither salary nor requirements. Salary commensurate with experience.