American Society of Gene & Cell Therapy

This is an exciting opportunity to work closely with emerging technology including but not limited to individualized DNA/RNA therapies, Cell therapies, and Stem Cell therapies.. The person has the expertise to run all operations, including but not limited to: preparation of components, solutions/buffer preparation, cell culture, filtration, chromatography, formulation, fill- finish, and other aseptic operations.. Benchwork/lab work experience preferred (working in biosafety cabinets, pipetting, PCR, purification, open and closed cell culture, aseptic technique, etc). This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote.. Manufacturing Engineer - Manufacturing & Injection Moulding & Cad, Systems Engineer - Products Research & Development, Research & Development Engineer, Senior Characterization Engineer, Field Process Engineer, Process Engineer, R&D Engineer - II, Mechanical Engineer - Solidworks, DevOps Research & Development, Member Of Technical Staff - R&D Engineering

manufacturing engineer

The Position  At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity, and diversity. We believe every employee makes a difference. We are passionate about transforming patients’ lives. We are courageous in both decision and action; we believe that good business means a better world.
Genentech is offering an exciting opportunity for the right individual to join Genentech’s Hillsboro Individualized Therapies (HIT) team, working to bring new medical advancements from development stages to commercial manufacturing. This is an exciting opportunity to work closely with emerging technology including but not limited to individualized DNA/RNA therapies, Cell therapies, and Stem Cell therapies. This is the start-up headquarters for Genentech’s individualized and cell therapies division where we will establish the industry standard. As a member of the team you would be responsible for supporting multi-phase technology transfers and production, including:
Working with scientists and development leads to establish a framework for developing manufacturing processes, controls, and procedures, and transferring these new technologies to the site.

Working with our Manufacturing Sciences and Technology (MSAT) team to qualify and validate new equipment and processes.

Owning the development of all batch related documentation including manufacturing batch records, standard operating procedures, training materials, and associated forms.

Collaborating with compliance and quality members to assess process risks and establish appropriate controls for product safety and efficacy.

Works collaboratively in a team environment with end to end responsibility for all aspects of manufacturing operations for clinical and/or commercial products. The person has the expertise to run all operations, including but not limited to: preparation of components, solutions/buffer preparation, cell culture, filtration, chromatography, formulation, fill- finish, and other aseptic operations.

Collaborating cross-functionally to find innovative solutions for process implementation.

Perform all process simulations to demonstrate successful process implementation, for development, for training, and for enabling clinical and commercial supply.

Supporting all activities necessary for GMP operations and commercialization.

Utilizing LEAN methodologies to realize improvements /efficiencies in the processes, increase uptime of equipment, debottleneck the processes, improve yields, and implement standard work to maximize productivity.

Utilize single-use technology, new analytical techniques, and digital manufacturing systems to maximize capacity of a best in class bioprocess facility.

Owning process deviations. You will perform initial triage of unplanned events, act as the unplanned event owner, leading root cause analysis when deviations occur, and developing corrective actions to prevent recurrence.

Promoting a learning culture by training on new processes / procedures and training others.

Travel will be required to support technology transfers and training purposes. May require extended duration trips depending on the needs of the project.

This is a multi-faceted role offering variety in daily responsibilities and project-based work. Therefore, the ability to self-manage tasks and meetings to hit project timelines is a must. This role also requires engagement with other departments including quality, compliance, maintenance, engineering, and analytical development technology to collect the right information for the best decision-making.
Qualifications / Requirements:
Bachelor’s degree and 1 year of experience or an equivalent combination of education and experience

Experience with technical writing / documentation authoring

Support equipment operations including qualification, validation, establishing equipment procedures, supporting maintenance, routine operations, and advanced troubleshooting analysis and process operation

Must be computer literate. GSuites is a must.

Experience working in a commercial or clinical GMP environment

Must be able to travel domestically and internationally to development sites

Must be flexible to work off shift hours to support business needs

Preferred:
Degree in cellular or molecular biology or engineering

Previous experience with individualized cell and/or gene therapies is strongly preferred; applicants with cell/gene therapy experience will be given preference

Experience driving continuous improvement / using LEAN methodologies

Experience with data analysis software, ERP systems, Manufacturing Execution Systems, and quality management systems

Benchwork/lab work experience preferred (working in biosafety cabinets, pipetting, PCR, purification, open and closed cell culture, aseptic technique, etc)

Experience managing deviations in a GMP environment or supporting impact assessments

Knowledge of Health Authority requirements

Physical Requirements:
When working in the clean rooms, you will be required to wear Genentech-provided safety shoes

You should be able to lift up to 25lbs on rare occasions

You will work in a clean room environment; you will be required to gown in the form of hospital scrubs, bunny suits, gloves, hair net, mask, safety glasses, hearing protection.

All candidates must pass a vision acuity and color discrimination test

Must complete periodic physical examinations to identify medical conditions which pose a risk to Grade C or higher operation

No makeup or jewelry can be worn when working in the clean room environment

You may work with hazardous materials and chemicals

Relocation benefits have been approved for this posting.
#LI-CA1
#cellandgenetherapycareers#
Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.
Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.
As a member of the team you would be responsible for supporting multi-phase technology transfers and production, including. Working with scientists and development leads to establish a framework for developing manufacturing processes, controls, and procedures, and transferring these new technologies to the site. Working with our Manufacturing Sciences and Technology (MSAT) team to qualify and validate new equipment and processes. Owning the development of all batch related documentation including manufacturing batch records, standard operating procedures, training materials, and associated forms. Collaborating with compliance and quality members to assess process risks and establish appropriate controls for product safety and efficacy. Works collaboratively in a team environment with end to end responsibility for all aspects of manufacturing operations for clinical and/or commercial products. The person has the expertise to run all operations, including but not limited to: preparation of components, solutions/buffer preparation, cell culture, filtration, chromatography, formulation, fill- finish, and other aseptic operations. Collaborating cross-functionally to find innovative solutions for process implementation. Perform all process simulations to demonstrate successful process implementation, for development, for training, and for enabling clinical and commercial supply. Supporting all activities necessary for GMP operations and commercialization. Utilizing LEAN methodologies to realize improvements /efficiencies in the processes, increase uptime of equipment, debottleneck the processes, improve yields, and implement standard work to maximize productivity. Utilize single-use technology, new analytical techniques, and digital manufacturing systems to maximize capacity of a best in class bioprocess facility. You will perform initial triage of unplanned events, act as the unplanned event owner, leading root cause analysis when deviations occur, and developing corrective actions to prevent recurrence. Promoting a learning culture by training on new processes / procedures and training others. This role also requires engagement with other departments including quality, compliance, maintenance, engineering, and analytical development technology to collect the right information for the best decision-making. Support equipment operations including qualification, validation, establishing equipment procedures, supporting maintenance, routine operations, and advanced troubleshooting analysis and process operation . When working in the clean rooms, you will be required to wear Genentech-provided safety shoes. You will work in a clean room environment; you will be required to gown in the form of hospital scrubs, bunny suits, gloves, hair net, mask, safety glasses, hearing protection. Must complete periodic physical examinations to identify medical conditions which pose a risk to Grade C or higher operation. Manufacturing Engineer - Manufacturing & Injection Moulding & Cad, Systems Engineer - Products Research & Development, Research & Development Engineer, Senior Characterization Engineer, Field Process Engineer, Process Engineer, R&D Engineer - II, Mechanical Engineer - Solidworks, DevOps Research & Development, Member Of Technical Staff - R&D Engineering
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