Production Support Associate I

Position Summary
To assist Manufacturing Operations by supporting technology transfers and technology implementation (manufacturing process, and ancillary procedures) at HCATS in accordance with defined scope of work, timelines, and budgets contracted with clients.

Essential Functions and Responsibilities

Assist in the maintenance of existing and implementation of new/additional low/medium complexity Client Programs through:

Assess client technology, resource and logistics assessment efforts in preparation for tech transfer to the any of the PCT facilities
Supporting Operations Technical Trainers with the development of the Training Plans
Identification of the requisite skillset and competencies for the program-specific tech transfer team and working with relevant functional leads to assemble to team
Knowledge transfer/training as defined in the Training Plan
Participation in the monitoring, evaluation and documentation of the knowledge transfer/training outcome
Coordination of the technology implementation team to deliver key implementation milestones such as: development and implementation of program-specific documents (i.e., Master Batch Records, SOPs, Test Methods, ancillary protocols) within the document control system; facilitating raw material sourcing; facilitating raw material sourcing; facilitating equipment and instrument commissioning; establishing the development/facility resources;; effective transfer of the manufacturing process and procedures; final documentation

Support Training, Engineering and Clinical Readiness runs to meet project timelines/deliverables
Write internal technical documents, such as protocols (i.e.; Engineering, Clinical Readiness, APS, etc…), reports, SOPs, and work instructions
Execute assignments in alignment with pre-planned scope of work, timeline, and budget
Collaborate with adjacent functions
Serve as Subject Matter Expert for cell therapy processes where sufficient knowledge and experience has been demonstrated.
Perform work within the context of sound scientific and engineering principles and consistent with relevant industry practices such as, Quality by Design (QbD) and Good Manufacturing Practices (GMP).
Support the efficient operation of development laboratories

Competencies

Aligns with the core values of the company
Flexible and able to adapt to company growth and evolving responsibilities
Structured approach to thinking and planning
Analytical and problem-solving skills with innovation-seeking mindset
Strong communicator and listener
Can-do attitude

Qualifications

Bachelor’s degree in relevant life science or engineering discipline
Minimum of 2 years combined industry/academic experience in cell processing, cell culture, cell analytics, and related GMP technologies, preferably for manufacture of cell therapy products
Demonstrated excellence in technical writing in the preparation of, protocols and reports, presentations and/or other communications
Understanding of the technical principles, theories and concepts of low complexity technology transfer and the manufacturing of cell therapy or similar products
Ability to provide technical solutions to a variety of technical problems of low complexity scope and the ability to suggest improvements and adaptations to methodologies, processes, products
Prior experience with development or use of closed systems or automation for cell therapy manufacturing is desirable

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.

Minimum Required Training

GMP training
Gowning training/qualification
Aseptic process qualification (personal media fill)

Aseptic Processing Standards

The employee must be able to comply with HCATS personal hygiene standards as they apply to aseptic processing. The employee must successfully complete sterile gowning training/qualification and aseptic process qualification (personal media fill) as well as annual/semiannual re-qualification as a core competency requirement of their employment in this role.

Working Environment

Must have the ability to work in a team-oriented environment and with clients
Must be able to work during the weekend, holidays and as required by the company
May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids
Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen
Must have the ability to work in the cleanroom environment for extended period of time
Must have the ability to work with specialized equipment
Must be able to handle the standard/moderate noise of the manufacturing facility
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 employee is frequently required to lift, move, or carry up to 50 pounds and occasionally move tanks up to 300 pounds (with assistance).
Heavy cryo-gloves must be used when working with liquid nitrogen
Gowning proficiency as needed.

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
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.