MSAT - Engineer

Minaris•Allendale, NJ

1d•Hybrid

About The Position

Position Summary 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 Regular and reliable attendance on a full-time basis. Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.Embodies Minaris Advanced Therapies values and aligns daily actions with department and company culture. 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 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 Leadership Responsibility May indirectly supervise the following roles: Associate Engineer Senior Associate Engineer Knowledge, Skills & Ability Collaboration, Accountability, Adaptability, Can-do, Technical Capacity, Problem Solving, Customer-centric, and Good communication Education & Experience 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 protocolsDemonstrated ability to deliver projects to specific timelines and budgets Experience 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 communications Basic understanding of the technical principles, theories, and concepts of cell therapy or similar products Quality Requirements Ensure compliance with all FDA and Worldwide Quality & Compliance regulations in all aspects of your work. Adhere to established procedures and protocols, prioritize continuous training and skill development, and uphold the highest standards of data integrity to ensure accuracy, compliance, and operational excellence. Working Environment Remote: Employee will work with moderate noise level within an office or home office setting. Employee will perform tasks while experiencing numerous interruptions. Employee may travel by car and airplane to work at different locations and may occasionally be required to travel overnight. The work environment is fast paced. This position has the utmost responsibility for adherence with the rules and regulations regarding a compliant work environment relative to their actions and conduct. Off-shift, weekend and overtime duties may be required. While performing the job duties of this job, the employee is regularly required to use English written and oral communication skills. Onsite Employees: Employee will work with moderate noise level. Employee will perform tasks while experiencing numerous interruptions. Employee may travel by car and airplane to work at different locations and may occasionally be required to travel overnight. The work environment is fast paced. This position has the utmost responsibility for compliance with the rules and regulations regarding a safe and healthy work environment relative to their actions and conduct. Off-shift, weekend and overtime duties may be required. While performing the job duties of this job, the employee is regularly required to use English written and oral communication skills. 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. May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids Must have the ability to work with specialized equipment May work with hazardous materials and chemicals Environment requires gowning, hair net, safety glasses, gloves, and foot coverings. Physical Requirements The physical and mental demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. While performing the duties the employee is: Constantly required to sit, and to reach to use computers and other office equipment Constantly stand for extended periods of time, up to four hours/time Frequently required to lift up to 40 pounds Constantly required to view objects at close and distant ranges with hand and eye coordination Frequently required to communicate with others Note: For the purpose of this summary, occasionally it is used to represent up to 1/3 of the time given to the work day; frequently represents 1/3 to 2/3 of the time and constantly represents 2/3 or more of the time. Special Working Conditions 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. Disclaimer The 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.

Requirements

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

Responsibilities

Perform laboratory experiments for client projects
Perform analytical testing for client projects
Preparation and scheduling of laboratory equipment for experiments
Generate experiment protocols and reports for development projects
Generate draft batch records and other manufacturing documentation
Generate manufacturing risk assessments, such as FMEA
Compile and analyze experimental data
Present experimental data internally and externally to clients
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
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