KBI: US - Downstream Process Development Scientist II

JOB SUMMARY The Downstream Process Development (PD) Scientist II provides process development ownership for a product, including all development and design decisions, with some oversight and supervision from senior process development staff. They can apply advanced scientific principles to design and execute laboratory studies for unit operation development and optimization, and solve problems of increasing scope and complexity. They possess a strong working knowledge of the downstream functional area with strong aptitude in chromatography and tangential flow filtration, and a developing understanding of phase-appropriate practices and expectations. They author and review technical documents including protocols and reports commensurate with PD compliance and quality standards. This workflow encompasses process development scope as well as support of technology transfer activities in preparation for cGMP production. The PD Scientist II is responsible for maintaining training compliance, according to site expectations. This is a salaried exempt position, with the expectation to cover shift work as needed to support laboratory activities and organizational need. Responsibilities Executes process development, process characterization, and technology transfer of microbial processes to commercial cGMP facility. Works toward developing a broad knowledge of state-of-the-art principles and theory. Responsible for producing high quality documentation and client reports suitable for publication and regulatory requirements. Compiles and presents data to clients. Supports downstream process development efforts in the laboratory and manufacturing areas. Executes experiments with some oversight. Conceptualizes and proposes process development and manufacturing based on process data. Execution includes downstream unit operations such as chromatography, tangential flow filtration, normal filtration, as well as sampling and basic analysis of process samples; concentration, pH, and conductivity. Will lead the downstream portion of development, process characterization, and/or technology transfer programs, acting as subject matter expert (SME), and directing the efforts of the team in meeting the project deliverables. Provide technical support for cGMP manufacturing through floor coverage, batch document review, and support of deviations and change controls with some oversight. Responsible for developing/maintaining a current understanding of cGMP and other regulatory requirements. Adheres to all safety requirements and assures that departmental employees comply with required safety procedures. Conceptualizes, proposes and executes the evaluation, development and implementation of new downstream technologies leading to process improvements and efficiency of operation in support of downstream process development and manufacturing activities. Documents procedures, observations, and results in laboratory notebooks and responsible for maintaining training compliance, according to site expectation. Reviews documentation and records as assigned. REQUIREMENTS B.S. degree and a minimum of 6+ years of related experience; M.S. and 4+ years of related experience or Ph.D. and 1+ years related experience in a scientific discipline. Experience with downstream process development and chromatography equipment required. Excellent written and verbal communication skills, focus on customer service, and ability to meet strict client deadlines. Highly collaborative. Flexibility of hours to support downstream processes. Knowledge of GMPs and biotechnology-derived product regulations preferred. Salary: $106,480-$146,410 KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal. At KBI, we are constantly seeking to improve our team with accomplished individuals who share in our commitment to serve our clients as they seek to advance important medicines to the patients who need them. We offer our employees a challenging, rewarding and fast-paced environment along with the opportunity for career advancement through the development of one’s technical skills. At KBI, employees work in a collaborative, team environment, where sharing knowledge and expertise with one another is strongly encouraged. If you do not see a position that matches your background, we invite you to return to our site often as positions are updated frequently. Please Note: To 3rd Party Search Firms/Employment Agencies: All inquiries must be directed to [email protected]. Please do not call or email any KBI Biopharma employee about current or future job openings. All resumes submitted by search firms or employment agencies to any employee at KBI Biopharma via-email, telephone, social media or other means will be deemed to be the sole property of KBI Biopharma, unless the firm submitting the resume has previously entered into a written agreement with KBI Biopharma regarding recruitment services and has been approved by Human Resources to work on an open position. KBI Biopharma will not pay any fee or remuneration with respect to candidates without complying with this requirement.