Senior Analytical Development Scientist •PC 543

Senior Analytical Development Scientist Production and Manufacturing - San Jose Site Your Role This position is primarily responsible for the technical leadership needed to support the Process Development team. The Analytical Development Scientist will coordinate with Business Development and Project Management teams to develop the technical specifications associated with projects for clients. With little or no supervision from management, the position will review and summarize data for presentations and reports as well as leading the transfer of processes and / or analytical methods from Process Development into Manufacturing and / or Quality Control. This position will oversee the activities of associates and lower-level scientists. Essential Duties and Responsibilities Meet with potential clients to provide technical information as it relates to client requirements for Process Development. Collaborate with Business Development and Project Management teams by communicating Process Development technical capabilities to generate proposals, statements of work, timelines and ensure timely initiation and completion of all studies Support Business Development and Project Management teams with technical expertise for Kick-Off with client. Review client data and develop Process Development Plan Write Statement of Work (SOW) for technical resources including costs of labor and material using available information Act as subject matter expert in specified areas of cell process development (may include assay development) Interact closely with client representatives to ensure expectations are met. This would include input into the design and execution of studies as well as ongoing scientific support throughout different projects / programs Analyze data, summarize results (for internal and client presentation) and writing of reports (interim and final) Generate Process Development technical timeline and ensure timely initiation and completion of all studies Generate Process Development Protocols to serve as guidance for study execution as well as means for real-time documentation Participate in critical event / lab investigations / troubleshooting within Process Development and liaise with Project Management to ensure the significance of events is actively communicated to clients Lead by example, offer scientific coaching and mentoring to other staff members (training and scientific support for ongoing projects) Monitor industry trends to ensure that relevant new technologies can be assessed and evaluated. Review and recommend potential technical developments to supervisor and management Maintain complete and detailed lab notebooks as well as other necessary documentation Participate in department and team meetings and report on status Train other PD and Manufacturing personnel as needed Requirements Ph.D. or master's degree from a four-year college or university in a scientific discipline related to cell processing; 5 - 8 years of related experience; or equivalent combination of education and experience. Relevant working knowledge and hands‑on experience in areas executing and overseeing cell processing projects (such as Immunology, Molecular Biology, Cell Biology, etc.) and / or technical expertise (such as cellular assays, flow cytometry, ELISA, PCR, etc.). Experience handling blood and / or other human tissues. Experience in supervising / leading project teams, through direct reporting authority as well as by influence. Experience with developing cell therapy products intended for patient infusion (for routine treatment or clinical trials) preferred. Experience working in a GTP, GLP or GMP compliant environment preferred. Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel; reach with hands and arms, talk, and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch. The employee must occasionally lift and / or move up to pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail. Work Environment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in a temperature-controlled facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in a cleanroom setting and routinely uses standard medical and research equipment such as centrifuges, biosafety cabinets, microscopes, incubators, filters, peristaltic pumps and metering fill pumps, pipettes and computers. While performing the duties of this job, the employee is frequently exposed to blood, viruses, bacteria, body fluids and other tissues. Employees entering and leaving the laboratory must wear appropriate clothing and protective equipment such as lab coats, glasses and gloves. The noise level in the work environment is usually moderate. The hiring range for this position is expected to fall between $ , - $ , / year, reflecting the range candidates can reasonably expect to be considered for at time of offer, based on factors such as experience, internal equity, and qualifications. The salary of the finalist(s) selected for this role will be set based on a variety of considerations, including but not limited to internal equity, experience, education, specialization, skills, abilities, and training. The above range represents the Company’s good faith and reasonable estimate of possible compensation at the time of posting. In addition to your salary, the Company offers a comprehensive benefits package, including health, vision, and dental insurance, as well as a (k) plan. All benefits are subject to eligibility requirements. Certain positions may also be eligible for additional compensation such as bonuses or commissions. Miltenyi Biotec, Inc is an EO Employer – M / F / Veteran / Disability / Sex #J-18808-Ljbffr