Scientist, Upstream Process Development
About the Job
**__Essential Functions:__** * Develop, optimize, and scale-up bacterial and mammalian cell and virus/viral vector-based processes, including cell banking, adherent and suspension cell cultures in batch, fed-batch, and perfusion modes. * Plan, generate and execute protocols for DOE studies that include appropriate statistical analysis and generate and present reports. * Plan and perform metabolite/spent medium analyses, medium development and cell line development studies. * Assemble, operate, and troubleshoot single-use stirred tank bioreactors from bench scale to 200L working volume scale. * Plan and execute various centrifuge and cell/virus culture harvest protocols. * Support GMP manufacturing through tech transfer, training, and master batch record generation and review. * Generate scientific reports, including process development reports, manufacturing summary reports, and supportive reports for IND CMC sections. * Cross-train in Downstream PD, Virology and Analytical Development groups to gain knowledge and functional capability in these areas. * Plan, perform and evaluate relevant in-process assays and report results. * Generate and present oral presentations for peers and senior management, as required. * Ensure maintenance and monitoring of process development equipment. * Manage direct reports to be engaged and productive, and address work productivity issues as they arise. * Ability to work effectively in a matrix management environment. * Perform all other duties as assigned. **__Required Skills & Abilities:__** * Experience in upstream process development of mammalian, viral and bacterial cultures and upstream purification of biological products. Experience monitoring the performance of laboratory processes and equipment. * Strong working knowledge of cGMP (current Good Manufacturing Practices). * Ability to work independently and within a team. * Ability to provide observations within a developing process. * Strong attention to detail. * Excellent verbal, written and organizational skills. * Strong computer skills (Microsoft Office products including Excel, Word, Outlook and PowerPoint). * Strong organizational and analytical skills. * Strong interpersonal and leadership skills. **__Preferred Skills & Abilities:__** * Experience with cGMP operations, manufacturing, QA, QC, and regulatory requirements for pharmaceutical products. * Experience performing Phase 1 clinical manufacturing. * Experience in performing analytical methods supporting process development and/or GMP manufacturing. * Strong background in virology and microbiology. **__Supervisory Responsibility:__** Carries out supervisory responsibilities in accordance with company policies and applicable laws including interviewing, hiring, planning, assigning, directing work, training and development, disciplinary actions, performance reviews, addressing complaints and resolving problems. **__Working Conditions & Physical Requirements:__** 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: * Experience prolonged standing, along with some bending, stooping, and stretching. * Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. * Attendance is mandatory. * Ability to occasionally travel to other sites, vendor locations, and/or conferences. **__Minimum Qualifications:__** * Master’s Degree preferably in Chemistry, Biology, Life Sciences or related field, with four (4) years of relevant experience; OR * Bachelor’s Degree preferably in Chemistry, Biology, Life Sciences or related field, with five (5) years of relevant experience. **__Preferred Qualifications__** * Leadership in a regulated/biotech environment producing viral vaccines.