Pharma Technical Operations (PT) manages manufacturing, supply chain, and quality across the pharmaceutical network. Within PT, PTT (MSAT & Engineering) leads the technology that ensures PT stays at the forefront of innovation, supporting robust processes and efficient operations. We are seeking a highly skilled Medical Device Platform Technical Lead to develop and maintain Ocular Port Delivery Device platforms used in drug-device combination products. In this senior level role, you lead a cross‑functional technical team to design and maintain robust delivery platforms in both development and commercial lifecycles. Responsibilities Lead Platform Technology teams in creating and maintaining the Platform Design History File (DHF) across development and commercial lifecycles, collaborating with product and molecule teams, CDMOs/CMOs, and sustaining partners. Drive platform initiatives that support product design and development teams, strategically planning and implementing platform data leverage plans and providing technical support for end‑to‑end project activities. Work with global cross‑functional teams to broaden understanding and implementation of product and platform development principles within established processes. Develop and nurture relationships with third‑party development partners worldwide. Provide technical expertise in systems engineering principles, including user and stakeholder needs definition, requirements definition, risk management, product architecture, configuration management, traceability, change management, and reliability for platform devices. Develop, harmonize, and streamline platform‑based verification and testing methodologies across the delivery device portfolio. Collaborate closely with regulatory teams to ensure compliance with applicable regulations and standards, preparing and reviewing technical documentation for regulatory submissions and audits. Manage CDMO relationships related to platform‑focused design activities for device platforms. Qualifications BS in Mechanical Engineering or an equivalent technical degree with 10+ years of experience, including in‑depth knowledge of surgical implants, prefilled syringes, autoinjectors, PFS‑Needle Safety Devices, or novel drug delivery design and manufacturing processes. Technical expertise in device and integrated combination product development, comprehensive understanding of pharmaceutical and delivery system processes, and knowledge of Medical Device regulations. Experience with Requirement Management, including Requirement Hierarchies, Traceability, Authorship, Platform vs Variant modalities, and projects that utilize continuous improvement methods and toolsets. Excellent communication, interpersonal, and collaboration skills to engage cross‑functional teams, external suppliers, and industry partners, with the ability to influence across scientific disciplines and organizational boundaries. Entrepreneurial spirit, hands‑on, roll‑up‑your‑sleeves approach, and a high sense of urgency and dedication to deliver results. Compensation and Benefits The expected salary range for this position, based on the primary location of South San Francisco, California, is $157,000 to $291,600. Actual pay will be determined based on experience, qualifications, geographic location, and other job‑related factors permitted by law. Relocation benefits are not available for this posting. Benefits are available according to the company policy. Employees may qualify for a discretionary annual bonus based on individual and Company performance. Equal Employment Opportunity 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