Genentech
Associate Engineer/Engineer Manufacturing Engineer (Cell & Gene Therapy)
Genentech, Hillsboro, Oregon, United States, 97104
The Position
Our Hillsboro Individualized Therapies (HIT) team at Genentech is at the forefront of bringing new medical advancements from development stages to commercial manufacturing. As a member of our Manufacturing team, you will have the unique opportunity to work with cutting-edge technologies such as individualized DNA/RNA therapies, cell therapies, and stem cell therapies. You will play a crucial role in supporting multi-phase technology transfers and production, collaborating with experts in Manufacturing Sciences and Technology (MSAT), and ensuring the highest standards of quality and safety for our innovative therapies. This role offers a dynamic and diverse range of responsibilities, where you will have the chance to work collaboratively with various departments and contribute to the advancement of healthcare for patients in need.
Must be able to work all shifts (1st, 2nd, or 3rd, weekends, holidays, 12 or 10 hours), require overtime as needed, and stand for extended periods.
This position is located on-site in Hillsboro.
The Opportunity As an Associate Manufacturing Engineer/Manufacturing Engineer, your main responsibility will be to support technology transfers and production of innovative cell and gene therapies. You will work collaboratively with various teams to establish manufacturing processes, controls, and procedures, while transferring new technologies to the site. You will play a key role in onboarding new equipment and processes in collaboration with our MSAT and compliance teams.
Additionally, you will:
Own the development of batch-related documentation, including manufacturing batch records, SOPs, training materials, and associated forms
Collaborate with compliance and quality members to assess process risks and establish controls for product safety and efficacy
Lead end-to-end manufacturing operations for clinical and/or commercial products, encompassing solutions/buffer preparation, cell culture, gene editing, cellular isolations, guided stem cell differentiation, filtration, chromatography, formulation, fill-finish, and aseptic operations
Drive process improvements and efficiencies using LEAN methodologies, implementing standard work and maximizing productivity
Utilize single-use technology, new analytical techniques, and digital manufacturing systems to optimize bioprocess facility capacity
Who You Are
You possess a Bachelor’s degree and 1-2 years (for Associate Engineer level) or 4 years (for Engineer level) of relevant cell and/or gene therapy industry experience
You have experience authoring and reviewing GMP documents such as SOPs, Batch Records, Learning Curriculum, Development Protocols and Qualification Documents
You have experience working in a commercial or clinical GMP environment
You have experience with technology transfers
You have experience as a trainer or leading a small team
You are available to work off-shift hours to support business needs
Preferred
Bachelor’s degree in cellular or molecular biology or engineering
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 (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
Experience with New Product Introductions
Change Control
Knowledge of Health Authority requirements
The expected salary range for this position based in Oregon is $61,000- $113,000 (for Associate Engineer level) and $78,000 - $146,000 (for Engineer level). Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
Benefits
Relocation benefits are approved for this posting.
This is an on-site position; no remote options are offered at this time.
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
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Must be able to work all shifts (1st, 2nd, or 3rd, weekends, holidays, 12 or 10 hours), require overtime as needed, and stand for extended periods.
This position is located on-site in Hillsboro.
The Opportunity As an Associate Manufacturing Engineer/Manufacturing Engineer, your main responsibility will be to support technology transfers and production of innovative cell and gene therapies. You will work collaboratively with various teams to establish manufacturing processes, controls, and procedures, while transferring new technologies to the site. You will play a key role in onboarding new equipment and processes in collaboration with our MSAT and compliance teams.
Additionally, you will:
Own the development of batch-related documentation, including manufacturing batch records, SOPs, training materials, and associated forms
Collaborate with compliance and quality members to assess process risks and establish controls for product safety and efficacy
Lead end-to-end manufacturing operations for clinical and/or commercial products, encompassing solutions/buffer preparation, cell culture, gene editing, cellular isolations, guided stem cell differentiation, filtration, chromatography, formulation, fill-finish, and aseptic operations
Drive process improvements and efficiencies using LEAN methodologies, implementing standard work and maximizing productivity
Utilize single-use technology, new analytical techniques, and digital manufacturing systems to optimize bioprocess facility capacity
Who You Are
You possess a Bachelor’s degree and 1-2 years (for Associate Engineer level) or 4 years (for Engineer level) of relevant cell and/or gene therapy industry experience
You have experience authoring and reviewing GMP documents such as SOPs, Batch Records, Learning Curriculum, Development Protocols and Qualification Documents
You have experience working in a commercial or clinical GMP environment
You have experience with technology transfers
You have experience as a trainer or leading a small team
You are available to work off-shift hours to support business needs
Preferred
Bachelor’s degree in cellular or molecular biology or engineering
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 (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
Experience with New Product Introductions
Change Control
Knowledge of Health Authority requirements
The expected salary range for this position based in Oregon is $61,000- $113,000 (for Associate Engineer level) and $78,000 - $146,000 (for Engineer level). Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
Benefits
Relocation benefits are approved for this posting.
This is an on-site position; no remote options are offered at this time.
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
#J-18808-Ljbffr