Scientist-Engineer, MSAT at Minaris
MOFFETT FIELD, CA 94035
About the Job
Scientist-Engineer, MSATAt Minaris Regenerative Medicine our vision is creating future cell therapy miracles together
We are a leading global contract development and manufacturing organization dedicated to the advancement of cell and gene therapy products
We believe in the transformative potential of cell and gene therapies and we are shaping the future of medicine
We open doors in the regenerative medicine industry for those looking to transform medicine while continuously improving an innovative, growing company. The Scientist-Engineer, MSAT performs process and analytical experimental studies as part of a team that is effectively delivering cell therapy services to clients in accordance with defined scope of work, timelines, and budgets
This includes leading projects in process development, technology transfer and continuous improvement of our client's novel manufacturing processes
Our goal is to support our clients in developing commercially viable cell therapy products, so that they can become accessible to all. Essential Functions and Responsibilities Accountable for the design and execution of experimental studies in the laboratory, for example:Perform laboratory experiments for client projectsPerform analytical testing for client projectsPreparation and scheduling of laboratory equipment for experimentsProvide technical leadership of client products during manufacturing and development, for example:Direct technical communication with clients during manufacturing and developmentSupport manufacturing in identifying and resolving manufacturing process constraintsLead the generation of manufacturing and development documentation, for example:Generating experiment protocols and reports for development projectsGenerating draft batch records and other manufacturing documentationGenerating manufacturing risk assessments, such as FMEAPerform data analysis to reach actionable conclusions, for example:Compile and analyze experimental dataPresent experimental data internally and externally to clients Qualifications Minimum of a Bachelor's degree in relevant life science or engineering disciplineMinimum of 3 years' experience in aseptic cell processing, cell culture and cell analytics under the guidance of scientific protocolsDemonstrated ability to deliver projects to specific timelines and budgetsExperience in working effectively and delegating tasks in a team-based environmentDemonstrated ability in technical writing and the preparation of, protocols and reports, presentations and/or other communicationsBasic understanding of the technical principles, theories and concepts of cell therapy or similar products Competencies/Candidate Profile Collaboration, accountability, adaptability, can-do, leadership, technical capacity, problem solving, customer-centric, communication, project management, and presentation skillsQuality Requirements Build Quality into all aspects of your work by maintaining compliance to all quality requirements.Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).Attend all required Quality & Compliance training at the specified interval. Minimum Required Training Aseptic processing, Good Manufacturing Practice (GMP), communication skills, specific process and analytical equipment Supervisory Responsibilities This job has no supervisory responsibilities. Working Environment Must have the ability to work in a team-oriented environment.May occasionally be exposed to loud sounds and distracting noise levels, such as from office equipment or people located in open floor environment. This role operates within a professional office environment of a manufacturing operations plant
This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines
Seating is mixed and includes open space seating, cubicle, and office space. Physical Requirements The physical demands described here represent those that must be met by an employee to perform the essential functions of the job successfully. Ability to lift, transfer, or ship validation equipment or related accessories up to 30 pounds.An individual may occasionally exert up to 30 pounds of force or a negligible amount of force frequently to lift, carry, push, pull, or otherwise move objects
Sedentary entails sitting most of the time but may involve walking or standing for brief periods.Must be capable of moving, sitting, stretching, stooping, reaching with hands and arms, and have vision sufficient to read materials. Must be capable of using hands and fingers to operate a computer and other office productivity machinery such as copy machine, printer, and calculator.Must have the ability to communicate information and ideas so others will understand
Must be able to exchange accurate information in person, and on the telephone.DisclaimerThe above information in this description is intended to describe the general nature and level of work performed
It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job
Duties, responsibilities, and activities may change at any time with or without notice.Monday-Friday, Day Shift
We are a leading global contract development and manufacturing organization dedicated to the advancement of cell and gene therapy products
We believe in the transformative potential of cell and gene therapies and we are shaping the future of medicine
We open doors in the regenerative medicine industry for those looking to transform medicine while continuously improving an innovative, growing company. The Scientist-Engineer, MSAT performs process and analytical experimental studies as part of a team that is effectively delivering cell therapy services to clients in accordance with defined scope of work, timelines, and budgets
This includes leading projects in process development, technology transfer and continuous improvement of our client's novel manufacturing processes
Our goal is to support our clients in developing commercially viable cell therapy products, so that they can become accessible to all. Essential Functions and Responsibilities Accountable for the design and execution of experimental studies in the laboratory, for example:Perform laboratory experiments for client projectsPerform analytical testing for client projectsPreparation and scheduling of laboratory equipment for experimentsProvide technical leadership of client products during manufacturing and development, for example:Direct technical communication with clients during manufacturing and developmentSupport manufacturing in identifying and resolving manufacturing process constraintsLead the generation of manufacturing and development documentation, for example:Generating experiment protocols and reports for development projectsGenerating draft batch records and other manufacturing documentationGenerating manufacturing risk assessments, such as FMEAPerform data analysis to reach actionable conclusions, for example:Compile and analyze experimental dataPresent experimental data internally and externally to clients Qualifications Minimum of a Bachelor's degree in relevant life science or engineering disciplineMinimum of 3 years' experience in aseptic cell processing, cell culture and cell analytics under the guidance of scientific protocolsDemonstrated ability to deliver projects to specific timelines and budgetsExperience in working effectively and delegating tasks in a team-based environmentDemonstrated ability in technical writing and the preparation of, protocols and reports, presentations and/or other communicationsBasic understanding of the technical principles, theories and concepts of cell therapy or similar products Competencies/Candidate Profile Collaboration, accountability, adaptability, can-do, leadership, technical capacity, problem solving, customer-centric, communication, project management, and presentation skillsQuality Requirements Build Quality into all aspects of your work by maintaining compliance to all quality requirements.Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).Attend all required Quality & Compliance training at the specified interval. Minimum Required Training Aseptic processing, Good Manufacturing Practice (GMP), communication skills, specific process and analytical equipment Supervisory Responsibilities This job has no supervisory responsibilities. Working Environment Must have the ability to work in a team-oriented environment.May occasionally be exposed to loud sounds and distracting noise levels, such as from office equipment or people located in open floor environment. This role operates within a professional office environment of a manufacturing operations plant
This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines
Seating is mixed and includes open space seating, cubicle, and office space. Physical Requirements The physical demands described here represent those that must be met by an employee to perform the essential functions of the job successfully. Ability to lift, transfer, or ship validation equipment or related accessories up to 30 pounds.An individual may occasionally exert up to 30 pounds of force or a negligible amount of force frequently to lift, carry, push, pull, or otherwise move objects
Sedentary entails sitting most of the time but may involve walking or standing for brief periods.Must be capable of moving, sitting, stretching, stooping, reaching with hands and arms, and have vision sufficient to read materials. Must be capable of using hands and fingers to operate a computer and other office productivity machinery such as copy machine, printer, and calculator.Must have the ability to communicate information and ideas so others will understand
Must be able to exchange accurate information in person, and on the telephone.DisclaimerThe above information in this description is intended to describe the general nature and level of work performed
It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job
Duties, responsibilities, and activities may change at any time with or without notice.Monday-Friday, Day Shift
