Cell and Gene Therapy Associate I

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.

Under the supervision of an Associate Manager / Manager, a Cell and Gene Therapy Associate I will execute various regenerative medicine processes, including cell product manipulation and cryopreservation using good aseptic technique, adhering to Company written Standard Operating Procedures (SOPs) and in accordance with cGMP practices. Facility and personnel specific responsibilities will be regulated by Company policies and or client procedures being performed at each respective location.

We are looking for people who share our core values, who are passionate and results-driven, believe in keeping an open mind and building open connections, are agile and flexible, and show solid vision and solid integrity.

Essential Functions And Responsibilities

Performs processing for Minaris RM clients in accordance with established written procedures. Processing can include transferring of materials, sample and media preparation, manipulation of cell cultures and various drug products using good aseptic technique, taking/submitting requisite samples for testing, and cryopreservation of products using DMSO solution and controlled rate freezers while performing documentation in accordance with Good Documentation Practices (GDP) and Current Good Manufacturing Practices (cGMP).

Proficiently operates within a cleanroom suite environment to include ISO Class 7 (Class 10,000) / ISO Class 6 (Class 1,000) / and ISO Class 5 (Class 100) grade level areas, while ensuring personnel and product safety.

Proficiently operates, sanitizes, monitors, and maintains equipment according to designed procedures.

Has the ability to work in a team-oriented environment and with clients.

Communicates effectively with Company’s Operations management team and all other cross-functional departments.

Notifies management of any deviation that may occur during processing or during equipment maintenance, will initiate appropriate response in accordance with Company’s Quality Management System

Participates in the on-call program.

Qualifications

Associate or Bachelor’s degree in a scientifically related field or commensurate experience.

Relevant Industry / Cell Processing Experience Preferred

Experience working with standard office equipment / applications (Microsoft Office, Outlook)

Competencies/Candidate Profile

Functional/Technical Skills: Having/developing knowledge and skills to do the job at a high level of efficiency and accomplishment.

Customer Focus : Meeting the expectations and requirements of internal and external customers in gaining trust and respect in delivering a product and/or service.

Ethics and Values : Adhering to a set of core values and beliefs that governs a standard of conduct based on what is right or wrong; practices what he/she preaches.

Integrity & Trust: Working with a high level of integrity and builds trust between stakeholders (peers, managers).

Personal Disclosure: Ability to self-assess strengths, weaknesses and limitations; holds self-accountable for objectives and mistakes.

Demonstrating Patience: Listening and checking before acting; tries to understand the people and the data before making judgments.

Technical Learning: Ability to continuously learn and apply new skills and knowledge related to the industry, company, and products.

Supervisory Responsibility

No supervisory responsibilities

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)

Working Environment

May be exposed to infectious diseases transmittable through human blood or bodily fluids.

Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen. PPE includes gowning, hair net, safety glasses, gloves, and boot covers.

Must have the ability to work in the cleanroom environment for extended periods.

Will be required to work within the standard / moderate noise of a cell processing facility.

Will be required to work with hazardous materials and chemicals.

Must have a flexible work schedule, which can include work during the weekend, holidays and as required by the company.

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, and filing cabinets. 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.

Employee will be required to frequently lift and or move up to 30 pounds

Appropriate PPE must be worn at ALL times 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 through verbal and written communication.

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.

Sunday: 10 hours - flexible start (based upon process)

Monday: 10 hours - flexible start (based upon process)

Thursday-Friday: 7:00-5:30