At Miltenyi Biotec, 3,000 employees worldwide develop pioneering solutions for biomedical science and the clinical application of cell therapies. Our multidisciplinary team combines excellence in research with the development of innovative products for the treatment of serious diseases.Process Engineer, Manufacturing Sciences and Technology Gaithersburg, MDTasks:
As a member of the Miltenyi Biotec team, you will analyze process technologies in support of new project proposals and assist in the technical transfer into the manufacturing group. Additionally, you will work in a collaborative manner, coordinating the transfer of biological drug processes from process development (internal or client) groups in a CMO environment. You will be responsible for manufacturing data collection and analysis and leading the technology transfer of small to medium scope clinical cell therapy projects for internal and external clients. This role may serve as a process owner and may drive Continuous Improvement projects and Business Process Improvement activities of a medium scope. As a result of your data tracking and trending, technology transfers, product lifecycle management and reporting, operations support, as well as your continuous improvement,you will support the continued success of Miltenyi Biotec as a whole.Among other responsibilities, you will:
- Lead technology transfer of client (internal and external) cell therapy projects into Manufacturing.
- Review, approve and/or author GMP documentation, protocols and reports.
- Troubleshoot processing issues, including investigation for root cause and implementation of corrective and preventive action (CAPA) plans.
- May serve as process owner and drives Continuous Improvement Projects.
- May lead risk assessments, root cause analysis and similar activities.
- Participate in research and development activities.
- Lead multiple overlapping cross-functional technology transfer teams that include client technical staff and internal process development and manufacturing teams.
- Identification of single-use process equipment of appropriate scale and quality for continued process improvement.
- Prepare user requirements, obtain vendor quotes, and capital expenditure justification for equipment.
- Provide technical information for the preparation of change controls, protocols, and new user training for the process equipment and processes.
- Author/review process specifications and provide input for scale up and requirements for GMP manufacturing.
- Author/review/approve batch records.
- Author/review/approve Campaign summary reports, interim reports, manufacturing regulatory support documentation as applicable.
- Assist with identifying raw materials and consumables of appropriate quality for the cGMP execution of client specified manufacturing processes;
- Assist in the preparation of material specifications, vendor quotes, and the purchase of the materials.
- Respond to client and/or internal staff questions or concerns about cGMP equipment, materials, and procedures.
- Use key and critical process parameters and their associated critical quality attributes in the preparation of product specifications.
- Provide data analysis from each manufacturing run that may be included in intermediate and/or final project summary reports and other team deliverables.
- Contribute to and ensures the achievement of goals and tech transfer milestones on multiple projects with minimal delay in schedule or excessive use of resources.
- Data tracking, trending, analysis and reporting.
- Initial trainer of Manufacturing staff on process overviews and/or new equipment.
- Bachelor's Degree in Engineering, Chemistry, Biology, Life Sciences or related field or related scientific discipline. 2-5 years of relevant experience in a cGMP environment in relation to biologics and cell therapy manufacturing; or equivalent combination of education and experience.
- Must be authorized to work in the U.S.
- Please note that this position may require vaccination against COVID-19, unless individual is entitled to reasonable accommodation under applicable law.
- Experienced withapproving/revising cGMP related documents
- Familiar with manufacturing planning and scheduling practices
- Operational Excellence and Continuous Improvement Concepts (Six Sigma, Lean/Agile).
- Understanding of statistical methods and/or software (JMP, Minitab, R)
- Exposure to process/product development within a regulated environment
- Microsoft Office (Excel, PowerPoint, Project, Word, Visio, Outlook, Teams)
- Understanding of cGMP and regulations/guidance. Can interpret guidance documents and make technical recommendations
- Hands on process development or manufacturing experience with clinical scaleup projects
- Experience with single-use manufacturing equipment and materials.
- Understanding and experience in aseptic techniques.
- cGMP Document writing experience including protocols, batch records, SOPs and summary reports and other associated Manufacturing documents.
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 50 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 clean laboratory setting and routinely uses standard medical and research equipment such as centrifuges, biosafety cabinets, microscopes, incubators, chromatography devices and columns, tangential-flow filtration devices and 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.
AtLentigen Technology, Inc. support the development and commercialization of novel treatments for human disease through the utilization of Lentiviral Vectors. We hold this widely recognized and clinically relevant method for delivering genetic materials into cells in order to modulate their function as core strength of our company. We are scientists, engineers, physicians, support specialists, and more – all dedicated to improving scientific understanding and impacting human lives. At our Gaithersburg campus we strive to find solutions to both the technical and conceptual barriers to the implementation of gene therapy approaches for the treatment of human disease.
Lentigen Technology, Inc. is an EO Employer – M/F/Veteran/Disability/Sexual Orientation/Gender Identity.
- Agile Methodology
- Attention To Detail
- Business Process Improvement