ENGINEER, CMC ENGINEERING

Job Description

Job 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