Manufacturing Operations Specialist, Trainer

Job Description

The Manufacturing Operations Specialist, Training will assist with facilitating trainings, tracking metrics, and actively improving upon the training program at the Vertex Manufacturing Center. This trainer will need strong technical knowledge on either adherent or suspension cell culture. The incumbent will work in collaboration with drug product development teams through all phases of development, process validation and commercialization to understand process requirements and provide feedback on process performance.

Key Duties and Responsibilities:

• Follow strict adherence to cGMP requirements including:

• Compliance with all on-going training requirements

• Following SOPs, policies, and all other relevant work instructions to ensure the successful and compliance operation of the drug product facility

• Monitor GMP compliance in all cGMP activities with co-workers and anyone working within the Drug Product facility

• Execute and witness batch record instructions during cGMP operations

• Interface with cleaning staff, and Facilities/Operations to make sure the facility meets its intended use requirements as well as to schedule routine cleaning and all the necessary calibration and preventive maintenance activities

• Interface with all appropriate key stakeholders, such as Quality and EH&S to ensure appropriate procedures are followed to ensure successful operation of the drug product facility

• Interface with Materials Management and the Release and Stability Laboratory to coordinate the purchase and delivery of necessary materials and the testing of routine cleaning and release samples.

• Ownership of cell life cycle

• Initializing and hosting trainings

• Actively work with management to improve training process

• Mentor new members on GxP processes

• Develop, Organize, Implement, and present technical training documentation and materials

• Perform on-boarding training to new members

• Assigning and maintaining the appropriate curriculum to the necessary members

• Train and certify technicians on cell culture manipulations, both adherent and suspension.

• Track metrics and provide management with the necessary reports on status of training.

• Collaborate with SMEs and management to develop training programs, training records,

• Active participant in process improvement meetings

• Maintain historic and ongoing training profiles and reporting for internal users

Knowledge and Skills:

• Ability to follow verbal and written instructions

• Ability to generate clear written documentation, including strong technical writing

• Intermediate computer skills, including Word, Excel, Outlook, equipment interfaces and electronic quality systems

• Experience with quality systems

• Knowledge of federal requirements for GMP manufacturing (21CFR 210, 211) and Quality Systems (21CFR820)

• Good communication and documentation skills.

• Ability to work in a multi-disciplinary, collaborative manufacturing team with well-defined deliverables

• Experience with manufacturing systems utilizing computerized control systems and HMIs

• Basic understanding of the cGMP framework in the context of both development and commercial pharmaceutical drug product manufacturing environment

Education and Experience:

• High school diploma and technical certifications relevant to GMP biomanufacturing required; associate's or bachelor's degree in a relevant discipline preferred

• Minimum 1 year of experience in a GMP environment; experience working in process development and/or manufacturing of cell therapy products preferred

• Minimum 1 year experience with cell culture and demonstration of aseptic technique; experience with embryonic or induced pluripotent stem cell culture preferred

• Prior experience with scale-up processes preferred

Environment:

• Occasionally work inside the cleanroom wearing all required PPE to accomplish training tasks

• Occasionally move lab equipment and materials weighing up to 50 pounds

Flex Designation:

Flex Eligibility Status:

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com