ENGINEER, CMC ENGINEERING
Apply NowCompany: Minaris Regenerative Medicine
Location: Allendale, NJ 07401
Description:
Engineer, CMC Engineering
At 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.
Perform process and analytical experimental studies as part of a team that effectively delivers cell therapy services to clients in accordance with the 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 become accessible to all.
Essential Functions and Responsibilities
Accountable for the design and execution of projects in the laboratory, for example:
Perform laboratory experiments for client projects
Perform analytical testing for client projects
Preparation and scheduling of laboratory equipment for experiments
Lead the generation of manufacturing and development documentation, for example:
Generate experiment protocols and reports for development projects
Generate draft batch records and other manufacturing documentation
Generate manufacturing risk assessments, such as FMEA
Perform data analysis to reach actionable conclusions, for example:
Compile and analyze experimental data
Present experimental data internally and externally to clients
Provide technical leadership of client products during manufacturing and development, for example:
Direct technical communication with clients during manufacturing and development
Support manufacturing in identifying and resolving manufacturing process constraints
Participate in strategic planning and implementation for MSAT functions
Maintain process-specific resource models and communicate changes
Maintain process-specific dashboards and perform data trending analysis
Maintain process design history files and perform analysis
Assess new opportunities by evaluating process/QC for technical transfer readiness; support the sr. engineer/scientist as needed
Support the team with the master transfer plan during technology transfer post-establishment of the strategy
Advocate for hiring for PPU and identify skills sets needed (potentially go to S&OP)
Facilitate inter/intra-departmental communication
Communicate with clients about potential upsell and interface with account management and Mdev for availability
Serve as the main point of contact with the project manager on technical matters and communicate interactions to the team
Serve as the main point of contact for the client project-specific, technical matters and create proper communication channels
Align with the Production Support manager on roles within PPU; align on RACI (raise issues to the director)
Demonstrate leadership and mentorship
Demonstrate the ability to align with functions
Could have direct reports
Perform team building for effective internal information transfer
Qualifications
Minimum of a bachelor's degree in relevant life science or engineering discipline
Minimum of 3 years' experience in aseptic cell processing, cell culture and cell analytics under the guidance of scientific protocols
Demonstrated ability to deliver projects to specific timelines and budgets
Experience in working effectively and delegating tasks in a team-based environment
Demonstrated ability in technical writing and the preparation of, protocols and reports, presentations and/or other communications
Basic understanding of the technical principles, theories, and concepts of cell therapy or similar products
Quality 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.
Competencies/Candidate Profile
Collaboration, Accountability, Adaptability, Can-do, Technical Capacity, Problem Solving, Customer-centric, and Good communication
Supervisory Responsibility
May indirectly supervise the following roles:
Associate Engineer
Senior Associate Engineer
Minimum Required Training
GxP Required Training
Working 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. Noise level is moderate.
Must have the ability to work in a team-oriented environment and with clients
May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids
Must have the ability to work with specialized equipment
Must be able to handle the standard/moderate noise of the manufacturing facility
May work with hazardous materials and chemicals
Environment requires gowning, hair net, safety glasses, gloves, and foot coverings.
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 the job.
This role is sedentary. 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.
Disclaimer
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
Monday-Friday, Day Shift
At 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.
Perform process and analytical experimental studies as part of a team that effectively delivers cell therapy services to clients in accordance with the 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 become accessible to all.
Essential Functions and Responsibilities
Accountable for the design and execution of projects in the laboratory, for example:
Perform laboratory experiments for client projects
Perform analytical testing for client projects
Preparation and scheduling of laboratory equipment for experiments
Lead the generation of manufacturing and development documentation, for example:
Generate experiment protocols and reports for development projects
Generate draft batch records and other manufacturing documentation
Generate manufacturing risk assessments, such as FMEA
Perform data analysis to reach actionable conclusions, for example:
Compile and analyze experimental data
Present experimental data internally and externally to clients
Provide technical leadership of client products during manufacturing and development, for example:
Direct technical communication with clients during manufacturing and development
Support manufacturing in identifying and resolving manufacturing process constraints
Participate in strategic planning and implementation for MSAT functions
Maintain process-specific resource models and communicate changes
Maintain process-specific dashboards and perform data trending analysis
Maintain process design history files and perform analysis
Assess new opportunities by evaluating process/QC for technical transfer readiness; support the sr. engineer/scientist as needed
Support the team with the master transfer plan during technology transfer post-establishment of the strategy
Advocate for hiring for PPU and identify skills sets needed (potentially go to S&OP)
Facilitate inter/intra-departmental communication
Communicate with clients about potential upsell and interface with account management and Mdev for availability
Serve as the main point of contact with the project manager on technical matters and communicate interactions to the team
Serve as the main point of contact for the client project-specific, technical matters and create proper communication channels
Align with the Production Support manager on roles within PPU; align on RACI (raise issues to the director)
Demonstrate leadership and mentorship
Demonstrate the ability to align with functions
Could have direct reports
Perform team building for effective internal information transfer
Qualifications
Minimum of a bachelor's degree in relevant life science or engineering discipline
Minimum of 3 years' experience in aseptic cell processing, cell culture and cell analytics under the guidance of scientific protocols
Demonstrated ability to deliver projects to specific timelines and budgets
Experience in working effectively and delegating tasks in a team-based environment
Demonstrated ability in technical writing and the preparation of, protocols and reports, presentations and/or other communications
Basic understanding of the technical principles, theories, and concepts of cell therapy or similar products
Quality 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.
Competencies/Candidate Profile
Collaboration, Accountability, Adaptability, Can-do, Technical Capacity, Problem Solving, Customer-centric, and Good communication
Supervisory Responsibility
May indirectly supervise the following roles:
Associate Engineer
Senior Associate Engineer
Minimum Required Training
GxP Required Training
Working 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. Noise level is moderate.
Must have the ability to work in a team-oriented environment and with clients
May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids
Must have the ability to work with specialized equipment
Must be able to handle the standard/moderate noise of the manufacturing facility
May work with hazardous materials and chemicals
Environment requires gowning, hair net, safety glasses, gloves, and foot coverings.
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 the job.
This role is sedentary. 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.
Disclaimer
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
Monday-Friday, Day Shift