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Genentech

Genentech

Biotech firm creating medicines via R&D

MES Change Specialist

Full-Time
$79k - $146k/yr

+ Annual bonus + Relocation benefits

Mid
Bachelor's, Master's
Hillsboro, OR, USA
In Person

Relocation benefits are available.

About the job

Requirements
  • A Bachelor's degree in a relevant field plus 3-5 years of Manufacturing Execution System, electronic batch record, or computerized systems experience in regulated manufacturing, or a Master's degree in a relevant field.
  • Prior experience with construction, testing, and validation of computerized systems.
  • Extensive experience working in electronic change management systems such as TrackWise or Veeva to own changes and coordinate action items across multiple departments.
  • A strong understanding of test requirements for electronic data systems for regulatory compliance.
  • Knowledge of automation systems including SAP, Manufacturing Execution Systems, Programmable Logic Controllers, and Human Machine Interfaces.
  • Prior experience with sterile pharmaceutical manufacturing, including solution preparation, equipment preparation, liquid or lyophilized vial filling, prefilled syringe filling, formulation, inspection, or packaging.
  • Ownership of changes in a change management system such as Veeva from initiation through closure.
Responsibilities
  • Troubleshoot and identify resolutions for mechanical or automation-related failures in production.
  • Identify improvement opportunities by leveraging data analytics of system performance to reduce costs and increase efficiency.
  • Lead user-requirement gathering for operational needs and perform initial requirement assessments for Manufacturing Execution System modifications.
  • Own computerized system validation functions, including defining requirements and writing and executing test scripts.
  • Own, plan, execute, and improve the review of Manufacturing Execution System changes for assigned manufacturing processes through testing and implementation.
  • Monitor project schedules and escalate concerns to leadership with sufficient time for mitigation.
  • Assist with drafting test plans for Manufacturing Execution System changes, including comprehensive test plans or reports for new recipes.
  • Own Manufacturing Execution System-related deviations, including high-complexity or multi-site deviations related to Manufacturing Execution System defects, and ensure corrective actions effectively resolve issues.
  • Support Manufacturing Execution System components of site initiatives, including capitalized projects, technology transfers, drug substance or drug product changes, shutdown projects, and new launches.
  • Serve as audit support for Manufacturing Execution Systems by providing demonstrations and presentations and answering questions; support closure of Manufacturing Execution System-related regulatory findings when applicable.
Desired Qualifications
  • Experience troubleshooting Rockwell systems, including remote or on-site support.
  • Prior experience on electronic batch record or Manufacturing Execution System deployment projects.

About the company

Genentech is a biotechnology company focused on researching and developing medicines and therapies to address unmet medical needs. It uses large-scale R&D, with about 13,500 employees and 40 approved medicines; it develops biologics and other therapies marketed through healthcare providers, generating revenue from sales. It differentiates itself with a large patent portfolio (around 20,000 patents) and multiple FDA Breakthrough Therapy Designations, along with a patient-centric approach that weighs access and affordability. Its goal is to advance medical science and deliver high-quality, effective therapies that improve patient health and support the broader medical community.

Company Size

10,001+

Company Stage

Grant

Total Funding

$2B

Headquarters

San Francisco, California

Founded

1976

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Simplify's Take

What believers are saying

  • August 28, 2026, Genentech licensed DualityBio ADCs, with over $1 billion milestones.
  • August 24, 2026, Genentech licensed Hanmi’s HM17321 obesity drug for up to $2.3 billion.
  • August 20, 2026, Genentech committed $750 million to Hillsboro devices, expanding self-injection capacity.

What critics are saying

  • June 2026 layoffs hit 103 workers; August cuts added 118 more across South San Francisco.
  • July 29, 2026, Genentech sued Biocon over Perjeta biosimilar Bmab1500 in New Jersey.
  • Roche’s obesity push faces Lilly and Novo Nordisk; HM17321 remains only Phase 1.

What makes Genentech unique

  • Roche-owned Genentech pairs discovery with Roche’s global development and manufacturing scale.
  • September 2026: Genentech owns deep oncology patent estates and Perjeta, Ocrevus, and Tecentriq franchises.
  • Genentech’s South San Francisco base and 13,500 employees concentrate research, clinical, and commercial execution.

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Benefits

Performance Bonus

Relocation Assistance

Growth & Insights and Company News

Headcount

6 month growth

-4%

1 year growth

-4%

2 year growth

-4%
Swoop
Sep 4th, 2026
Personalization that respects privacy: rethinking relevance in healthcare.

Personalization that respects privacy: rethinking relevance in healthcare. The next era of pharma advertising is more human, more relevant, and more connected. While adhering to regulatory requirements remains essential, brand stories don't have to follow the same familiar formats. Across two conversations during Cannes Lions International Festival of Creativity 2026, leaders from Genentech, Swoop, and The Trade Desk explore how marketers can rethink creative, data, and media strategy to build stronger connections across the patient journey. Together, these conversations outline a more connected pharma playbook: * Create for the way people consume media today * Use data to find moments of relevance * Orchestrate formats and messages across every potential touchpoint Break out of the typical 60-second mindset. Most television creative for pharma brands follows a predictable pattern, Genentech's Head of Media and Innovation Marc Minassian explains, this rigid structure makes it difficult for life sciences spots to stand out, especially on linear TV. The regulatory boundaries that many brand marketers find limiting can inspire more inventive storytelling in Marc's experience. Instead of leading with a product claim followed by disclaimers, pharma marketers can lean on factual, relevant content that builds positive sentiment. Moving beyond the traditional 60-second linear format toward stronger, shorter creative across CTV, social, and online video. That shift starts with changing the order of operations, Marc says. Rather than treating linear TV as the default and every other channel as secondary, marketers should start creative development with the audience, the format, and the moment. This approach delivers more authentic storytelling, maximizes media efficiency, and engages patients more effectively. Personalization that respects privacy. In its second conversation on data-driven audience engagement, The Trade Desk's GM of Business Development Pharma Baron Harper, Genentech's Head of Digital Marketing Oz Demir, and Swoop's Chief Revenue Officer Katie Carr examine how healthcare marketers balance messaging relevance with privacy compliance. Effective engagement does not require one-to-one targeting. Instead, marketers can use aggregated, privacy-safe data to understand campaign context and deliver information that feels timely and personal. "Personalization does not mean it has to be one-on-one. It has to feel like it's one-on-one, and it has to feel relevant," Oz said. As consumer needs evolve across their health journey, segmentation must adapt dynamically. Consumers may shift based on what they research, engage with, or need next. This is where data and AI can connect signals and create an intelligence layer, helping marketers identify patterns, optimize faster, and make smarter decisions throughout a drug's commercial lifecycle. AI can help surface themes across large volumes of data, and human experts can recognize the emotional significance of a single patient's words or insight. Improving Patient Outcomes Swoop improves patient outcomes by connecting the signals that drive earlier diagnosis, better treatment decisions, and sustained adherence. The integrated, privacy-by-design platform enables life sciences companies to drive measurable patient and commercial outcomes with actionable intelligence - spanning patient and HCP audience targeting, community engagement, AI-powered web solutions, coordinated omnichannel activation, and prescription fulfillment.

Los Angeles Biotechnology Network
Sep 3rd, 2026
Ark Clinical Research joins Genentech's advancing Inclusive Research(R) Site Alliance.

Ark Clinical Research joins Genentech's advancing Inclusive Research(R) Site Alliance. LONG BEACH, Calif. & FOUNTAIN VALLEY, Calif.-(BUSINESS WIRE)- #AdvancingInclusiveResearch-Ark Clinical Research is pleased to announce its participation in Genentech's U.S. Advancing Inclusive Research(R) Site Alliance, a coalition of clinical research sites that collaborate with Genentech to ensure clinical research includes a broad spectrum of patients reflective of those who experience... Click here to view original post

Pharmacally
Aug 28th, 2026
DualityBio, Genentech strike ADC deal worth more than $1 billion in potential milestones.

DualityBio, Genentech strike ADC deal worth more than $1 billion in potential milestones. DualityBio and Genentech partner to develop next-generation ADCs using the DUPAC platform, with $45M upfront and over $1B in potential milestones. M.Pharm (Reg. Affairs) DualityBio has entered into a global collaboration and license agreement with Genentech, a member of the Roche Group, to develop ADCs incorporating payloads from its proprietary DualityBio Unique Payload Antibody Conjugate (DUPAC) platform. The agreement provides DualityBio with a $45 million upfront payment, more than $1 billion in potential development, regulatory and commercial milestones, and tiered royalties on annual net sales. Genentech will assume further clinical development and global commercialization after Phase 1a. Novel ADC payloads target resistance beyond topoisomerase inhibitors. DUPAC is one of four ADC technology platforms developed by DualityBio and focuses on payloads with novel mechanisms of action. The platform includes multiple distinct payloads, each built around a different antitumor mechanism. DUPAC pairs these novel payloads with optimized and compatible linker technologies that support systemic stability and tumor-selective payload release. The payloads also feature high potency, broad-spectrum activity across tumor types, short systemic half-lives that allow rapid clearance, and a bystander effect suited to heterogeneous solid tumors. The approach addresses an emerging challenge in ADC therapy. As topoisomerase inhibitor-based ADCs move into earlier treatment lines across major solid tumor indications, more patients are likely to progress after exposure to this payload class. DUPAC aims to provide alternative payload mechanisms that can retain antitumor activity in tumors resistant or relatively insensitive to topoisomerase inhibitor-based ADCs. Genentech targets remain undisclosed. Under the agreement, DualityBio will generate and develop ADCs against Genentech-defined oncology targets using payloads from the DUPAC platform. The specific targets have not been disclosed publicly. DualityBio will lead discovery and early global clinical development for the collaboration programs. Genentech receives exclusive worldwide licenses to the resulting ADCs and will assume sole responsibility for further clinical development and commercialization after Phase 1a. The companies have not disclosed specific ADC candidates, target indications, clinical trial designs or development timelines. Preclinical data provide the initial rationale. DUPAC encompasses several payloads, including DUP5, DUP9 and DUP10, with each acting through a distinct antitumor mechanism. DualityBio has presented preclinical data from DUP5- and DUP9-based ADC programs at multiple scientific meetings. These studies included activity in tumor models that were relatively insensitive to topoisomerase inhibitor payloads, as well as non-human primate tolerability findings. The company presented the data at AACR 2025, the 2025 AACR-NCI-EORTC International Conference and AACR 2026. The findings remain preclinical and do not establish clinical efficacy or safety in humans. The subsequent development of the Genentech collaboration programs will therefore determine whether the differentiated payload biology translates into meaningful therapeutic activity. Deal combines DualityBio and Genentech capabilities. DualityBio CEO John Zhu said the collaboration reflects the growing need for alternative payload mechanisms as topoisomerase inhibitor-based ADCs move into earlier lines of therapy. He highlighted DUPAC's potential to address resistance while broadening the biological scope of ADC programs. Boris L. Zaïtra, head of Roche Corporate Business Development, said the partnership supports Roche's broader effort to advance targeted cancer medicines through external innovation. Financial terms and path forward. DualityBio will receive $45 million upfront and is eligible for more than $1 billion in aggregate development, regulatory and commercial milestone payments across the collaboration programs, in addition to tiered royalties on annual net sales of approved products. The announcement does not disclose an equity investment as part of the transaction. The publicly disclosed economics therefore center on the upfront payment, potential milestones and sales-based royalties. DualityBio will advance the programs through discovery and early global clinical development, while Genentech is positioned to take over after Phase 1a. Key milestones will include selection of specific ADC candidates, clinical entry and determination of whether DUPAC's novel payload mechanisms can deliver differentiated efficacy with an acceptable safety profile. Reference. About the Writer Umesh Hanumante (M.Pharm) (LinkedIn) is a pharmacy professional and healthcare writer with a background in Regulatory Affairs, pharmaceutical innovation, and clinical research. He has around two years of industry experience as an Executive PMT at Troikaa Pharmaceuticals Ltd and qualified GPAT 2024. His areas of interest include regulatory compliance, dossier preparation, clinical trials, emerging therapies, and advancements in the global pharmaceutical and healthcare sector.

PR Newswire
Aug 28th, 2026
DualityBio enters a global collaboration and license agreement with Genentech to develop next-generation ADCs built on DualityBio's DUPAC novel-payload platform.

DualityBio enters a global collaboration and license agreement with Genentech to develop next-generation ADCs built on DualityBio's DUPAC novel-payload platform. Aug 28, 2026, 00:08 ET * Collaboration leverages DualityBio's proprietary DUPAC payload platform and early global clinical development capabilities, with Genentech assuming further clinical development and global commercialization * DUPAC, one of the DualityBio's four proprietary ADC technology platforms, comprises multiple payloads with novel mechanism of action designed to address resistance to the payload classes underlying currently approved ADCs * DualityBio to receive a US$45 million upfront payment, more than US$1 billion in potential milestone payments, and tiered royalties on net sales SHANGHAI, Aug. 28, 2026 /PRNewswire/ - DUALITYBIO Inc. (HKEX: 09606; "DualityBio" or the "Company") today announced that it has entered into a collaboration and license agreement with Genentech, a member of the Roche Group, to develop next-generation antibody-drug conjugates ("ADCs") built on the Company's proprietary DualityBio Unique Payload Antibody Conjugate ("DUPAC") platform. DUPAC is one of DualityBio's four proprietary ADC platforms and is dedicated to payloads with novel mechanisms of action. It comprises multiple distinct payloads, each built on a unique antitumor mechanism, paired with optimized and compatible linker technologies designed for systemic stability and tumor-specific release. DUPAC payloads are engineered based on a common set of criteria: high potency, broad-spectrum activity across tumor types, a short systemic half-life permitting rapid clearance, and a bystander effect suited to heterogeneous solid tumors. As topoisomerase inhibitor-based ADCs move into earlier lines of therapy across major solid tumor indications, patients who progress on this payload class represent a large and growing area of unmet medical need. The DUPAC platform is designed to retain antitumor activity in that setting and in tumors that are less responsive to topoisomerase inhibitor-based ADCs. Under the terms of the agreement, Duality will generate and develop ADCs against Genentech defined oncology targets using payloads from the DUPAC platform. For the collaboration programs, DualityBio will lead discovery and early global clinical development. Genentech receives an exclusive, worldwide license to the collaboration ADCs, and will assume sole responsibility for further clinical development and commercialization after Phase 1a. Under the agreement, DualityBio will receive an upfront payment of US$45 million and is eligible to receive more than US$1 billion in aggregate development, regulatory and commercial milestone payments across all programs, together with tiered royalties on annual net sales of approved products. "As topoisomerase inhibitor-based ADCs achieve broad clinical success and move into earlier lines of therapy, a growing unmet medical need is emerging for patients whose tumors are resistant or refractory to this payload class. We built DUPAC to help address this challenge with a family of next-generation payloads designed to overcome resistance and enable each ADC program to expand the breadth of the underlying tumor biology. By combining DualityBio's payload innovation and early-stage global clinical development capabilities with Genentech's deep oncology expertise and worldwide development reach, we can advance these programs with greater speed and scale and bring differentiated medicines to more patients around the world," said Dr. John Zhu, Founder and Chief Executive Officer of DualityBio. "By further enhancing targeted medicines like ADCs, we focus our innovation where the need is highest," said Boris L. Zaïtra, head of Roche Corporate Business Development. "Backed by Roche's decades-long legacy in oncology, collaborating with partners such as DualityBio enables us to identify novel treatment options, such that we can tackle patients' unmet needs in cancer care." About DUPAC DUPAC (DualityBio Unique Payload Antibody Conjugate) is DualityBio's proprietary platform for ADC payloads with novel mechanisms of action, and one of four ADC technology platforms developed by the Company alongside DITAC, DIMAC and DIBAC. DUPAC encompasses several payloads, including DUP5, DUP9 and DUP10, each acting through a distinct antitumor mechanism. Preclinical data on DUP5-based ADCs and DUP9-based ADCs, including activity in tumor models relatively insensitive to topoisomerase inhibitor payloads and non-human primate tolerability, have been presented at multiple medical conferences, including AACR 2025 (Abstract 5454), AACR-NCI-EORTC International Conference 2025 (Abstract B129 and Abstract B130), and AACR 2026 (Abstract 2657). About DualityBio DualityBio is a clinical-stage innovative biopharmaceutical company dedicated to developing next-generation antibody-drug conjugates (ADCs) for patients with cancer and autoimmune diseases. The Company has successfully built multiple next-generation ADC technology platforms with global intellectual property rights. Grounded in a deep understanding of disease biology, DualityBio has established a robust clinical-stage ADC pipeline and is conducting multiple global, multicenter clinical trials across nearly 20 countries, with over 3,500 patients enrolled to date. Furthermore, DualityBio has entered into several out-licensing collaborations with global pharmaceutical companies and leading innovative biotech firms. Serving as a global engine for ADC innovation, DualityBio continues to develop next-generation novel ADCs, including bispecific ADCs, ADCs with novel payloads, and autoimmune ADCs. Forward-Looking Statements This press release contains statements that may be deemed to be "forward-looking statements" within the meaning of applicable securities laws. These forward-looking statements can be identified by terminology such as "will," "expects," "anticipates," "aims," "intends," "plans," "believes," "may," and similar expressions. Statements that are not historical facts, including statements about the beliefs, plans, objectives, and expectations of Duality Biotherapeutics, Inc. (the "Company") regarding its business, research and development programs, and product candidates, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. A number of factors could cause actual results to differ materially from those contained in any forward-looking statement, including but not limited to risks related to the Company's research and development, clinical trials, regulatory approvals, commercialization, and general economic and industry conditions. SOURCE Duality Biotherapeutics, Inc.

Herald-Advocate Publishing Co. Inc.
Aug 28th, 2026
DualityBio enters a global collaboration and license agreement with Genentech to develop next-generation ADCs built on DualityBio's DUPAC novel-payload platform.

DualityBio enters a global collaboration and license agreement with Genentech to develop next-generation ADCs built on DualityBio's DUPAC novel-payload platform. * By Duality Biotherapeutics, Inc. * 5 hrs ago * Collaboration leverages DualityBio's proprietary DUPAC payload platform and early global clinical development capabilities, with Genentech assuming further clinical development and global commercialization * DUPAC, one of the DualityBio's four proprietary ADC technology platforms, comprises multiple payloads with novel mechanism of action designed to address resistance to the payload classes underlying currently approved ADCs * DualityBio to receive a US$45 million upfront payment, more than US$1 billion in potential milestone payments, and tiered royalties on net sales SHANGHAI, Aug. 28, 2026 /PRNewswire/ - DUALITYBIO Inc. (HKEX: 09606; "DualityBio" or the "Company") today announced that it has entered into a collaboration and license agreement with Genentech, a member of the Roche Group, to develop next-generation antibody-drug conjugates ("ADCs") built on the Company's proprietary DualityBio Unique Payload Antibody Conjugate ("DUPAC") platform.