Insmed jobs in San Diego, CA - 22 jobs

** **Who we are** A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche. Genentech is the founder of the biotechnology industry and has been delivering on the promise of biotechnology for more than 43 years. It has been a member of the Roche Group since 2009 and is one of its most important centres of pharmaceutical research. At Roche, the patient is at the heart of all R&D efforts, and delivering life-changing therapies to patients while also driving positive change in the global society is the impetus to everything we do. **The Opportunity** As a Manufacturing Technician, you will work within a team to produce and deliver quality products for patients around the world. We are a 24/7 site and the work load is divided across multiple organizations. Technicians are expected to work in a safe manner and follow our Standard Operating Procedures at all times. Doing these two critical aspects of our job helps us maintain our right to operate and commitment to governing bodies around the world. Our Manufacturing begins in Upstream, where we thaw and scale up our process. Some of the responsibilities for Upstream technicians are: preparing the medium needed for cell growth and maintaining our Cell Cultures which includes the set-up and breakdown of stainless steel bioreactors. In Downstream, technicians work on a series of operations to isolate, purify, and concentrate the product. This includes preparation of Buffers, cleaning and steaming in place Chromatography skids, and supporting formulation. **Who you are:** You are someone who wants to influence your own development and can work independently, with limited supervision. You are looking for a company where you have the opportunity to pursue your own interests; where a job title is not considered the final definition of who you are, but the starting point. Experience with biologics manufacturing is not necessary but preferred. Candidates must be able to work any of the following manufacturing shifts: - 12 hr Day Shift, 6:00 am - 7:00 pm, - Sunday -Tuesday plus every other Wednesday - Wednesday - Friday plus every other Saturday - 10 hr Day Shift, 6:00 am - 4:30 pm - Sunday - Wednesday - Wednesday - Saturday - 10 hr Swing Shift, 3:30 pm -2:00 am - Sunday - Wednesday - Wednesday - Saturday - 12 hr Night Shift, 6:00 pm -7:00 am - Sunday-Tuesday plus every other Saturday - Wednesday - Friday plus every other Saturday Onboarding practices vary with area, but may consist of a multi-week schedule of Monday - Friday 8am - 5pm followed by on the job training for multiple weeks Monday - Thursday or Tuesday - Friday 1:00pm - 11:30pm. Once onboarding and/or training is complete, you will be released to your assigned Manufacturing shift. Shift availability will be determined by matching candidates strengths to shift needs and are subject to change based on business needs and production schedules. Shift availability will be determined by matching candidates strengths to shift needs and subject to change based on business needs. **Behaviors, competencies, and qualities of the ideal applicant:** + Hardworking and fast learning individual that thrives in a high paced environment + Experience in clean room environment and familiarity with cGMP and ISO/FDA standards is strongly preferred + Ability to think critically and work both tactically and strategically + Strong quality mindset with attention to detail and a desire to deliver service excellence + Ability to work effectively with others, exhibiting a professional manner and establish constructive working relationships **Qualifications / Requirements:** + Proficiency in the English language- reading, writing, and communication. + Must be able to work all shifts, required overtime as needed, and stand for extended periods of time. + Must be able to interface with computer systems to successfully operate manufacturing equipment. Experience with distributed control systems or other manufacturing automation is preferred. + Must be able to successfully pass all job-related tests and certifications required for working in a cGMP quality environment including but not limited to: inspections and GMP requirements to perform essential functions of the job. + Must re-qualify every year on all job-related training and certifications as job or qualifications require. + May climb upwards of 6 flights of stairs a day to maneuver within the manufacturing facility. + Lifting up to 25lbs may be required. + The cleanroom environment requires that company provided gowning is worn. This may include plant uniform, coveralls, gloves and safety shoes. Additionally, regulations prohibit makeup, jewelry, and other personal items from entering the clean room environment. **Education:** + Bachelor's degree in Life Sciences or Engineering and 1 year related experience, or associates degree and 3 years of experience, or High School and 5 years experience. + Biotech certificate from approved program **Work Experience:** + Experience in a GMP working environment with Background in Cell Culture/Purification is highly desired for 2-4 years (within the last 7 years) experience in the operation of complex mechanical equipment used in the washing, autoclaving, and assembly of parts used in Upstream or Downstream processes. + Target industries include pharmaceutical, biotechnology, biomedical, electronic, and chemical, food, cosmetics, and/or other medical industries. + Understands the theory, concepts, and regulations behind biopharma technology and processes. **Computers:** + Must be computer literate, including ability to interface with computer systems such as Delta-V and PLC-based logic. + Must be comfortable working with Microsoft suite (Word, Excel, PowerPoint), navigating through web pages and e-mail. + Must possess basic typing skills and understand Google platforms. _Relocation benefits are not available for this posting._ The expected salary range for this position based on the primary location of California is $42,400 to $70,000. 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 (**************************************************** 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 (***************************************************************************************************** .

At Roche, we are committed to delivering greater benefits to our patients. To achieve this, we are seeking a hands-on Operational Excellence expert to drive breakthrough performance improvements and build long-term capabilities. This role is about delivering step-change improvements, not just marginal gains, by embedding structured, data-driven methodologies that enhance efficiency, quality, and overall operational performance. As a member of the Performance Excellence Delivery team within our Pharmaceutical Global Operational Excellence organization, you will work with site teams, integrating traditional Lean principles with cutting-edge digital solutions to drive true transformation. Our Holistic and well-defined Breakthrough Methodology follows four key steps: Diagnose, Design, Implement, and Sustain, ensuring a structured and lasting impact. This is a role for a true impact driver, someone who thrives in hands-on environments, collaborates closely with teams, and is passionate about accelerating performance and creating tangible, sustainable results. The Opportunity On-Site Performance Improvement - Partner with local teams to identify and implement measurable and sustainable operational enhancements Breakthrough Performance Gains - Lead structured initiatives that go beyond incremental changes, driving significant improvements in quality, efficiency, and productivity Sustainable Capability Building - Coach and develop teams to adopt best-in-class methodologies, embedding long-term operational excellence Systematic, Data-Driven Approach - Apply proven frameworks to ensure measurable, repeatable success Leveraging Digital for Operational Improvement - Utilize digital tools and data analytics to accelerate efficiency gains and optimize end-to-end processes Cross-Functional Collaboration and Change Leadership - Engage with all levels of the organization to drive alignment, secure buy-in, and foster a culture of continuous improvement Performance Monitoring & Long-Term Impact - Define and track key performance indicators to ensure initiatives deliver lasting business value, not just short-term fixes. Who You Are Bachelor's degree and a minimum of 8 years of related/relevant experience; or an advanced degree with 6 years of equivalent work experience. Extensive experience in pharmaceutical manufacturing or related field, with a focus on sterile environments (Highly preferred). Proven expertise in Lean methodologies and leading structured performance improvement initiatives. Demonstrated success in delivering transformational impact (step-change improvements), not just incremental changes, in operational environments. Demonstrated ability to synthesize complex information and data sets, extract actionable insights, and craft compelling presentations that drive decisions. Experiences in top consulting firms (Highly preferred). Locations This is a primarily on-site role in Oceanside. Relocation benefits are available for this position. The expected salary range for this position based on the primary location of Oceanside is $120,400 and $224,700. 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 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.

** A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Genentech, a member of the Roche Group! **The Opportunity** We are seeking an experienced and motivated Technical Development Scientist to join the Analytical Development team at Genentech San Diego. This position works with the PTCC team to develop and/or improve cell-based assays for cell product characterization and release. The Analytical Development Scientist participates in laboratory activities to support process development, evaluate and develop new assay methods, and perform product characterization for CAR-T cell products. The individual is also involved in assay optimization and standardization and assay transfer to internal or external QC labs. Under the reasonable supervision, the role includes performing assay development experiments, carefully documenting methods and materials, writing SOPs/reports, and communicating findings. The ideal candidate has a proven track record of innovation, demonstrated skill set and knowledge in process and analytical development, and is excited to take on new challenges in a fast-paced and dynamic environment. Responsibilities may include but are not limited to: + Develops analytical test method procedures in accordance with relevant guidelines from ICH, USP, EP for cell therapy product GMP release testing and characterization. + Supports analytical routine testing, qualification, and validation. + Evaluates reagents and supplies to meet QC standards + Co-authors test methods (SOPs), technical reports, and analytical sampling plans + Documents laboratory procedures and experiments with great attention to detail in laboratory notebooks + Performs assays for process assessment and product characterization + Participates in assay transfers to QC and provides lifecycle support + Summarize and present scientific data to project teams. + Evaluates alternative technologies to create robust and reproducible analytical methods + Sets up, monitors, samples, and analyzes cell culture processes + Works with R&D teams to gain deeper understanding of the analytical methods for characterization of product critical quality attributes **Who You Are** Requirements, Knowledge, Skills and Abilities + BS or MS degree in a relevant scientific discipline with five plus years of relevant experience in a biotech environment (an equivalent combination of education and experience may be considered) + Experience in human T cell biology with demonstrated proficiency in a broad range of cellular immunology techniques, including cell-based assays, immunoassays, and flow cytometry. + Experiences with aseptic cell culture (human primary cells and cell lines) and bio-assay development and/or testing + Ability to follow laboratory procedures with attention to detail, and successfully execute experiments at the bench + Demonstrated ability to maintain detailed lab execution records and perform data analysis + Excellent communication skills, data presentation and interpersonal skills + Basic computer skills in Excel, PowerPoint, and word processing + Attention to detail, initiative, and strong organizational skills + Comfortable in a fast-paced small company environment with reasonable direction and able to adjust workload based upon changing priorities. Preferred Qualifications + Two plus years of relevant cell therapy industry experience + Foundation in experimental documentation, basic statistical analysis, and data presentation + Exposure in vitro T cell functional assays (potency, cytotoxicity, ELISA, proliferation, Luminex) + Basic skills in molecular techniques including qPCR or dd PCR and electrophoresis. + Experience with drafting SOP and forms + Develops assays for cell product release and characterization by designing and executing studies via design of experiment (DoE) Relocation benefits are not available for this job posting. The expected salary range for this position based on the primary location of San Diego, CA is $80,500 - 149,500. 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 (**************************************************** 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 (***************************************************************************************************** .

** Our Supply Chain team in San Diego is looking for a highly motivated and pro-active individual who possesses a strong work ethic and collaborative spirit to join our integrated team. As a Materials Specialist you will be focused on providing support to all our innovative programs. You will play a vital role to ensure availability of materials to our internal research, development, and manufacturing teams. Your effort will support Genentech in providing a safe and efficacious off-the-shelf treatment for patients with multiple myeloma, B cell malignancies, and multiple solid tumors. In this role you will be working cross-functionally and collaborating with individuals and functions both within Genentech and third parties, he/she will support, receiving, warehousing, shipping, and inventory management related tasks. **The Opportunity** + Inspect and receive incoming deliveries at the receiving docks, gather packing slips and other documentation, and receive deliveries into the inventory system. + Put away received materials in appropriate locations in the warehouse. + Perform GMP receiving according to procedure and Good Documentation Practice (GDP). + Issue materials to manufacturing in accordance with GMP procedures. + Support manufacturing for after-hours product storage. Organize warehouse inventory locations for maximum efficiency. + Ensure continuous flow of received materials in accordance with hazard, safety, and GMP guidelines. + Perform cycle counts of materials in inventory. Support shipping of samples, general parcels, and manufacturing final product according to procedures. + Stock all areas of the research laboratories with appropriate supplies as needed. + Support the generation of data to be included in reports. Maintain files and documentation as related to all incoming and outgoing materials. + Work well in a team environment with shared responsibilities. + Additional responsibilities and duties as required. Who you are + HS/AA or G.E.D. degree with 3 plus years of receiving, shipping and warehouse management experience (an equivalent combination of education and experience may be considered). + Experience in a regulated environment (biotech, pharma, medical device, hospital or food manufacturing). + Ability to work collaboratively, effectively, and across departments in a fast-paced work environment. + Ability to perform multiple tasks simultaneously and accurately. + Solid organizational skills with attention to detail are required. + Strong communication skills Preferred + GMP warehouse experience a plus. + Proficiency with Microsoft Windows Computers running Google Workspace software. + Familiarity with the laboratory environment and/or Shipping & Receiving environment a plus + DOT Certification a plus + Familiarity with Dangerous Goods and IATA Regulations a plus **Work Environment/Physical Demands/Safety Considerations** + Physically capable of moving and lifting boxes up to 50lbs + Physically capable and proficient in the operation of a pallet Jack + Significant standing, walking, moving, carrying, bending, kneeling, reaching, handling, pushing, and pulling + Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements andwear protective clothing over the head, face, hands, feet, and body Relocation benefits not are available for this posting. The expected salary range for this position based on the primary location of San Diego, CA is $52,100 (min) - $74,400 (mid) - $96,700 (max) annual. 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 (*************************************************** 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 (***************************************************************************************************** .

** A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche. The position is located in **Oceanside, On-site. The schedule could include a rotating (10-12 hour shift), one weekend day, evening or night hours, or full off-shift hours.** In this dynamic role, you will be responsible for producing innovative biotherapeutic medicine by interfacing with highly automated production systems and controls in cGMP manufacturing environment, and maintaining areas in high state of inspection preparedness. Responsibilities include: + **Training and Compliance:** Provide coaching and training on best practices and compliance with Standard Operating Procedures (SOPs). Understand the theory, concepts, and regulations behind biopharma technology and processes. + **Production and Equipment Operation:** Prepare solutions for the production process. Operate systems that clean and sterilize tanks and filtration systems. Operate automated systems for equipment operation and assemble/prepare equipment for production. + **Continuous Improvement and Troubleshooting:** Participate in continuous operational improvement. Troubleshoot equipment and process issues and work with coworkers and supervisors for effective solutions. + **Documentation and Safety:** Review documentation and check all calculations (e.g., tickets, labels, equipment readings). Comply with safety requirements, Good Manufacturing Practices (cGMP), SOP, and manufacturing documentation. + **Support and Reporting:** Provide support to Manufacturing to meet production demands. Provide reports to management summarizing goal unit attainment and anticipate potential problems, taking preventative action as necessary. **Supplementary Responsibilities** + Operate bioreactors, centrifuges, other harvest systems and protein purifications units. + Operate and clean fixed tank and filtration systems. + Operate large scale column chromatography systems. + Operate small-scale cell culture areas and systems by operating, cleaning, set up, and maintaining 20L batch feed bioreactors; inoculating and maintaining spinner seed cultures using aseptic techniques, maintaining cell banks; and performing general seed lab operations. + Perform CIP and SIP. **Who you are:** **Minimum Qualifications:** + You have a High School diploma with 7+ years of related experience in a cGMP environment. + You have a background in Cell Culture/Purification. + You have good communication skills, both written and oral. + You have a Biotech certificate from approved program. + You are capable of writing detailed reports and summaries. + You possess a high level of automation and technical process knowledge as related to prep and process within area of responsibility. + You are familiar with computer-based systems. **Nice-To-Have Qualifications:** + You have a degree in Life Sciences or Engineering with 3 years of relevant experience, or an Associate degree with 5 years of relevant experience. **Physical conditions and PPE requirements:** + Ability to work a flexible shift structure + Expected to be on feet for 8 to 10 hours a day. + May climb upwards of 6 flights of stairs a day to maneuver within the manufacturing facility. + Lifting up to 25lbs may be required. + Environment requires that gowning in the form of hospital scrubs, bunny suits, gloves and steel toe boots be worn. Also, no makeup or jewelry can be worn when working in the clean room environment. + May work with hazardous materials and chemicals. _Relocation benefits are not available for this job posting._ The expected salary range for this position based on the primary location for this position of Oceanside, CA is $51,000- $94,800. Actual pay will be determined based on experience, level, 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. This position also qualifies for the benefits detailed at the link provided below. Benefits (**************************************************** 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 (***************************************************************************************************** .

A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Genentech! The newly formed Genetic Medicine Technology group in gRED (Genentech Research and Early Development) is redefining the future of cell and gene therapies. Our proprietary non-viral gene delivery and gene editing platforms, including lipid nanoparticles (LNPs), piggy Bac and Cas-CLOVER, enable the development of next-generation CAR-T therapies with the potential to cure cancer and genetic diseases. We are seeking a highly motivated leader with a strong technical background in nanoparticle and LNP-mediated nucleic acids drug delivery. This person will join a dynamic and talented research team advancing non-viral therapies. This individual will direct efforts in developing novel non-viral drug delivery vehicles by overseeing the nanoparticle/nanotechnology function, working closely with the head of GMT. This individual will collaborate directly with immunology, bioanalytical, molecular biology, and pharmacology functions at Genentech San Diego to advance both platform and pipeline programs. This individual will also collaborate broadly with Genentech San Francisco and Roche research and innovation sites. The ideal candidate will have deep technical expertise with LNPs and chemistry, with additional expertise in pre-clinical models, xenographs, and T cell biology/manipulation. The Opportunity * Lead all research efforts for nanoparticle formulation, analytical characterization, and primary functional evaluation. * Discover and optimize applications of novel lipids from diverse structural families for LNP-mediated delivery of nucleic acid payloads. * Co-lead screening efforts, in vitro and in vivo, working closely with molecular and in vivo pharmacology groups, to identify novel LNP formulations for optimal tissue/cell delivery. * Collaborate with diverse groups across the organization, including those representing cell therapy, vector engineering, pharmacology, translational biology, immuno-oncology, CMC, process development, and small molecule subject matter experts. * Study fundamental mechanisms of action including LNP circulation, cellular uptake, endosomal escape, and specific behaviors unique to a particular payload class. * Lead efforts to advance platform development for an in vivo therapeutic application of an LNP modality from concept through clinical validation. * Analyze and interpret complex datasets, prepare clear reports, and present findings in internal program meetings, cross-functional reviews, and governance forums. * Lead and contribute to external publications, conference abstracts, and patent filings relevant to LNP development for autoimmune, neurology, and oncology indications. Who you are * Ph.D. in chemistry, engineering, bioengineering, nanotechnology, material science or a related field with 15+ years of relevant industry and academic experience. A strong background in DNA delivery is a plus. * Experience successfully advancing a candidate to IND-enabling studies is required. * Proven expertise in nanoparticle science, especially LNP delivery systems and non-viral gene transfer/delivery. * Strong data analysis skills and familiarity with design of experiments statistical analyses for process optimization, using software such as JMP statistical tools. * Familiarity with nucleic acids chemistry and molecular biology is highly desirable. * A background working with targeted si RNAs, liposomes, or ADCs is valued. * Experience working in the immunology space and with T cells is a plus, though not required. * Excellent communication, organizational, and leadership skills. * Passionate for people development with a proven track record in developing staff and high performing teams * Exceptional people and team management skills Relocation benefits are available for this job posting. The expected salary range for this position based on the primary location of San Diego, CA is $185,900 - $345,200. 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 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.

At Roche, we thrive to deliver more benefits to our patients as part of our 10-year Pharma vision. An integral part to achieving this vision is to deliver new and innovative data analytics solutions to our scientists across Pharma Technical Operations (PT). To do so, we have formed a new organization called PT Digital and Operational Excellence (PTE) with the aspiration to build industry-leading digital and lean operations across functions and our entire manufacturing footprint. The Opportunity PTE is the new organization that will catalyze the global development and execution of PT's Digital and Operational Excellence strategy to enable PT to realize our performance promises. We will build a strong cross-functional and inclusive community, put the power of data into the hands of our people, further develop the Lean and Digital skills across PT, and scale up our Digital and Advanced Analytics solutions, for the benefit of our colleagues and patients. We aim to activate data citizenship and digital mindset, revolutionize our FAIR data ecosystem and systems landscape, re-design excellent processes, and generate transformative insights. We collaborate closely with global functions to deliver impactful value to our patients. What You'll Do We in PTE work in partnership across major global business functions: PT-Quality, PT-Development, PT-Regulatory, PT-Manufacturing, establishing and implementing an overall Digital / Technology strategy and drive the delivery and scale of key data & digital solutions in support of our vision. This role is responsible for driving value realization and sustainability through the delivery of key digital initiatives and use cases across sites and Business Units. You will partner with customers across IT and PT functions to architect the planning, execution, and sustainment of digital solutions to achieve the PT Digital Aspirations. * Leads cross functional and cross site team workshops to solve complex digital and process challenges. * Identify and quantify high value processes with low to moderate investment and associated digital solutions for business case discussions. * Leverages sophisticated analytical thought to exercise judgement and identify innovative solutions. * Lead or co-lead process improvement activities with site and global OE partners - Maps business processes, apply LEAN principles, recommends process improvements to best fit digital solutions. * Communicates difficult concepts and negotiates with others to adopt a different point of view. * Interprets internal business challenges and recommends best practices - people, process, tool use - to improve the adoption and sustained value of digital products and services. * Proactively seeks external learnings and solutions to serve as options to complex challenges. * Coaches sites and business partners to develop similar expertise and skills. * Ensure scalability across global footprint. * Facilitate solution shaping process across PTx for data and digital products. * Build ecosystem of partners around strategic pillars * Coordinate the build-up of capabilities. * Coach teams that are developing and deploying digital use cases (share best practices, agile ways of working, ensure full impact capture & coordination between different initiatives). * Support build-up and management of a digital community that's focused on value realization. * Other duties as needed to support data management, workforce strategy, product delivery, support strategy, partnership and collaboration with IT and other PTx functions. Who You Are Do you bring experience (7 or more years) in architecting and implementing digital transformations, preferably in the pharma industry and are looking for an impactful role? We are seeking an individual with excellent knowledge of the pharma data ecosystem, informatics systems, tools, and techniques with a focus on the customer. This entails a good understanding of the customers' business, challenges, and goals in a manufacturing and operations environment. Further competences and qualifications: * BS in Science or Engineering Field with a minimum of 10 years of related experience. MS preferred. * Focus on results and proactive in identifying solutions. * Skilled in managing cross-functional partner relationships in a complex organization. * Ability to inspire and lead cross-functional project teams * Strategic and analytical thinking. Relocation benefits are not available for this posting. The expected salary range for this position based on the primary location of Hillsboro, OR is $131,000 - $243,400. 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 #LI-PK1 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.

Doing now what patients need next… for a healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche. This role is based in Pharma Technical Operations Technology (PTT), an organization that is responsible for ensuring Pharma Technical Operations (PT) stays at the forefront of technology in our current and future facilities. PTT, composed of global MSAT and Engineering, plays a key role in leading seamless industrialization and thorough technical product management through integrating SHE, proactive maintenance, facility fitness, performance optimization, and scalable manufacturing processes and technologies in support of the manufacturing network. In this role, you will have the opportunity to shape the manufacturing network that delivers life saving medicines to patients. The Opportunity The Engineering Project Feasibility and Product Sourcing Leader within the PTT Asset Health & Future Assets (AHFA) group conducts early feasibility and product sourcing assessments for Global Engineering CapEx projects. This role ensures that capital investments and investments supporting sourcing decisions align with and enable the Pharma long-range plan. A core responsibility of this role is partnering closely with Network Strategy, Global Product & Supply Chain Management, manufacturing sites, and Finance to develop robust business cases that inform PT governance decisions regarding capital investments and product sourcings. * Secures buy-in from stakeholders and senior leadership, drives cross-functional alignment, and resolves issues within the engineering community and broader network for Global Engineering CapEx projects * Builds robust scenarios that model best- and worst-case outcomes and provide flexibility for informed decision-making in a dynamic business environment * Develops comprehensive business cases for capital projects, maintaining fiduciary responsibility for real estate and equipment assets * Assesses requirements for product launches, technology transfers, and capital investments; ensures assumptions across options are agreed upon and aligned with stakeholders * Conducts complex early feasibility assessments across sites and functions, collaborating closely with senior leaders, subject matter experts, and site engineering teams * Partners with the engineering community/network to apply technology standards that enable successful project outcomes and reduce business risk * Transitions completed early feasibility assessments to Project Initiation teams and contributes as an expert reviewer during project reviews Who You Are * Bachelor's degree in Engineering or related field * Minimum of 12 years of Pharmaceutical or Biotech experience, process engineering experience preferred * Minimum of 8 years of management leadership experience in a matrix organization * Experience in a complex global environment with CapEx project execution * International/global experience is strongly preferred * Flexibility for domestic and international travel as required Relocation benefits are not available for this posting. The expected salary range for this position based on the primary location of South San Francisco, California is $156,700 to $290,900. 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 #LI-PK1 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.

A healthier future. That's what drives us. Always innovating, we bring together dedicated people and diverse perspectives from across our global network, empowering each other to keep breaking new ground. That's what makes us who we are. That's what makes us Roche. This role is based in Pharma Technical Operations Technology (PTT), an organization that is responsible for ensuring Pharma Technical Operations (PT) stays at the forefront of technology in our current and future facilities. PTT, composed of global MSAT and Engineering, realizes new assets for the PT manufacturing network of drug substance, drug product, and device industrialization facilities. You will have the opportunity to build manufacturing facilities that deliver life saving medicines to patients. The Opportunity As a Capital Project Director, within the capital delivery group, you will be responsible for leading large and/or complex facility/equipment improvement projects within our US manufacturing network as well as potentially at our international sites. Build and lead the project team, motivating them through your strong communication and leadership skills with clear decision-making to maintain project flow. Model collaboration through strong partnership with User Team Lead and other key customers and stakeholders Champion both design and construction safety as a key priority, engaging the Safety, Health, and Environment team throughout the project lifecycle. Accountable for fiscal control of the project by Developing funding strategy in alignment with execution strategy, managing scope and schedule of the capital project within the agreed business case, and keeping team focused on execution plan Engage with senior executive sponsors, site leadership and other key leaders on development of business case, execution & funding strategy and resolution of any impediments that arise From early concept, through design, construction and commissioning and qualification,, deliver the project not relenting until the project's business intent is actually met. Who you are: B.S. in engineering, architecture or construction with a minimum of 10 - 15 years successfully managing projects in the biotech/pharmaceutical industry, with at least 5 - 10 years managing large, complex projects, some preferably in an international environment. Known for your exceptional interpersonal and leadership skills in capital project delivery. Proven expertise in effectively applying and/or developing advanced project management tools and methodologies. Broad understanding of the principles of various engineering disciplines, in-depth understanding of one engineering discipline directly related to Roche core business of manufacturing. Preferred: MS in Engineering and/or an MBA and/or a PE/equivalent Special knowledge requirements include biopharmaceutical and pharmaceutical processes and facility design approaches, plus solid understanding of Pharmaceutical cGMP requirements. Understanding of risk based qualification Lean Construction knowledge and practitioner Relocation benefits are not available for this posting. The expected salary range for this position based on the primary location of California is $136,200 to $253,000 annually. 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 #LI-PK1 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.

The Opportunity: This position, based in Genentech's Oceanside, California facility, provides the opportunity to have a key role in a highly automated pharmaceutical drug substance facility. The site employs highly integrated computer control systems to manage plant operations and manufacturing data. The candidate will report to the Site Head of IT OT, an organization that is currently undergoing a transformation towards digitalization, advancing fundamental elements to meet future needs, such as standardizing and leveraging new technologies. As part of the Oceanside IT OT team, you will have accountabilities for the Oceanside Manufacturing Execution System (MES), maintaining roadmaps and lifecycle plans, developing proposals, managing related backlogs, leading and/or participating in Build/Run Squads, and ensuring the support of Product Transfers and Make/Assess/Release in a 24x7 Good Manufacturing Practice (GMP) environment. As part of the Site Team and larger Global IT OT organization, you will also be expected to contribute to Manufacturing Operations Management initiatives and optimization/standardization of the global IT OT landscape. What you'll be working on: Database Development & Administration Design, implement, and optimize SQL Server databases supporting MES. Develop complex SQL queries, stored procedures, functions, and triggers. Perform database tuning, indexing, and query optimization for performance and scalability. Manage backups, restores, disaster recovery plans, and high-availability configurations. Build data extracts and reporting views for manufacturing and quality stakeholders. MES Application Engineering Configure, deploy, and maintain MES software (Emerson Syncade or Pharamsuite). Lead MES upgrades, patch management, and change controls. Troubleshoot MES application issues across the stack (UI, middleware, backend). Systems & Infrastructure Administration Manage Active Directory integration, user/group access control, and system security. Monitor server performance, capacity, and uptime with proactive alerts and logs. Support virtualization (VMware) and system redundancy for critical GMP applications. Compliance & Validation Ensure systems meet GxP and FDA 21 CFR Part 11 requirements. Author/execute technical validation documents (URS, FRS, DS, IQ/OQ/PQ). Support internal and external audits by providing technical and compliance evidence. Cross-Functional Collaboration Integrate MES with ERP, LIMS, DCS, and automation systems. Partner with Manufacturing, QA, Validation, and IT teams to deliver compliant, efficient solutions. Mentor junior engineers on SQL/database best practices, MES configuration, and system administration. Who you are: 5 - 6 years of MES experience in biotech, pharma, or other GMP-regulated manufacturing. Advanced SQL Server skills (query optimization, schema design, indexing, performance tuning). Strong Windows Server and Active Directory administration. Hands-on experience with MES platforms ( Emerson Syncade or Pharmasuite). Proven ability to troubleshoot system issues across multiple layers (application, DB, OS, infrastructure). Strong understanding of GxP, GMP ( CSV methodologies optional ) Preferred Technical Skills Scripting/automation (PowerShell, Python, or Bash). Experience with virtualization platforms (VMware, Hyper-V). Reporting/analytics tools (Crystal Reports). Knowledge of integrating MES with automation and shop floor systems (OPC). Relocation benefits are not available for this job posting. Pay transparency The expected salary range for this position based on the primary location of Oceanside is $80,500.00 - $149,500.000 USD Annual. 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 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.

Drive Scientific Impact at the Forefront of Innovation. Patients are at the heart of everything we do. As a key member of our Medical Affairs team, you will drive the strategic direction of our Transcatheter Heart Valve (THV) evidence generation and dissemination efforts-shaping the future of structural heart disease treatment through science, collaboration, and innovation. Your work will directly influence how life-saving data is created, shared, understood, and applied across the global medical community. Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards' groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. You will make an impact by: * Transforming Lives. Advancing Science. Leading with Purpose. * Leading Strategy & Execution: Spearheading the planning and operations of the THV Podium & Publication (PnP) Committee, aligning cross-functional teams to deliver high-impact scientific projects. * Delivering Executive Insights: Developing compelling, executive-level presentations and reports that simplify complexity and drive actionable outcomes for senior leadership. * Driving Evidence Planning: Collaborating with internal and external stakeholders to shape and execute a robust evidence generation roadmap that supports the overall THV business strategy. * Championing Investigator-Initiated Studies (IIS): Contributing to the IIS program by aligning research priorities with business strategy; serving as a thought partner to investigators and providing input to study designs, abstracts, and manuscripts. * Fostering Scientific Collaboration: Building and strengthening relationships with leading physicians, researchers, and thought leaders to advance shared goals in structural heart diseases. * Elevating Scientific Presence: Anticipating key data releases and ensuring strategic visibility at global congresses and podiums. * Supporting the Medical Affairs Team: Performing other duties as assigned by leadership. What you'll need (Required): * Bachelor's Degree in related field Plus 10 years of related work experience * Advanced degree (e.g., Masters, PhD, MD) in related field Plus 8 years of related experience * Ability to travel up to 10% (Domestic) * This role is posted as Hybrid in Irvine, CA, but we are open to considering highly qualified candidates for a remote U.S. arrangement, provided they can meet the travel requirement: up to 30% domestic travel, including regular visits to our Irvine headquarters. What else we look for (Preferred): * Holding an advanced degree (e.g., Master's, PhD, MD) in a related field * Thinking strategically with strong analytical and problem-solving capabilities * Demonstrating excellent Microsoft PowerPoint skills * Showing proven project management expertise and proficiency in Microsoft Office Suite (PowerPoint, Excel, Word, Teams, CoPilot) * Possessing working knowledge of clinical research methodologies and statistical principles * Exhibiting exceptional communication and relationship-building skills * Maintaining strict attention to detail and excellent follow-up * Adhering to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and taking adequate control measures to prevent injuries to self and others, as well as protecting the environment and preventing pollution within your span of influence/control Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California, the base pay range for this position is $142,000 to $201,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

We are seeking a skilled professional to oversee the development, maintenance, and advancement of the SAP system recipe and master data, supporting Oceanside Production. As a subject matter expert and liaison, the position involves collaborating with internal and external stakeholders to ensure seamless integration between SAP S4H, OMP, MES, LIMS, and paper-based systems. The ideal candidate will excel at leading cross-functional teams, identifying and solving challenges, driving measurable business results, and proactively proposing improvements. Additionally, this role requires engaging with the global business process management community and handling project and system implementation challenges with both teamwork and independent initiative. A strong understanding of broader manufacturing and operational functions-including Drug Substance and Drug Product processes, materials management, production scheduling, capacity management, and quality-is essential. The Opportunity The Senior Business Systems Analysts will be responsible for collaborating with suppliers/customers to identify, create, and manage SAP Master Data in order to enable planning and Make-Assess-Release processes. As a key team member on Business Systems Integration (BSI) Team, responsibilities of this position include: * Applies extensive theoretical and cross-functional expertise in the context of company objectives to independently address complex problems. Determines methods and procedures on new assignments. * Work is performed under limited direction. Establishes own work priorities and timeliness. May provide guidance and coordinate work activities of other personnel. * Develops solutions to a variety of complex problems and initiatives. Exercises judgement in selecting methods and techniques and evaluation criteria for obtaining results. Works on complex issues where analysis of situations or data, requires an in-depth evaluation of variable factors including inter-organizational impact. Regularly exercises independent judgment and discretion regarding matters of significance. * Interacts with senior internal and external personnel on significant matters. * Represents organization as a prime contact on initiatives and projects. * Develop SAP Master data for load into system. Coordinate and lead Data Definition and Deployment efforts with site and network representatives. * Adhere to change management processes to ensure data is deployed and maintained in a controlled manner. * Provide analysis and reporting of data to manage key performance indicators and Class A metrics. * Translate business requirements to technical specifications and collaborate with key stakeholders to complete requests. * Provide training on usage, enhancements and changes to business systems * Leads cross-functional teams in the identification and implementation of improvement initiatives, using LEAN techniques. Who you are * B.A. or B.S. degree with 2 to 4 years work experience in the pharmaceutical, biopharmaceutical or related industry, or a Master's Degree with 0-2 years relevant experience, or an equivalent combination of education and experience. * Experience with ERP systems Recipe Development, Master Data. * Full use and application of basic Supply Chain/Business Process/cGMP theories, principles, and techniques. * Possess strong analytical skills and understanding of systems and technical designs. * Knowledge of cGMPs and equivalent regulations * Demonstrated ability to effectively interpret Quality standards for implementation. * Demonstrated ability to manage small projects from initiation to delivery to achieve measurable results. * Demonstrated ability to independently evaluate situations and propose potential solutions. * Demonstrated ability to communicate clearly and professionally both in writing and verbally. * Demonstrated ability to quickly learn a broad range of skills * Flexibility in problem solving and work hours to meet business objectives and dynamic. * production requirements Preferred: * Experience in GMP Biopharmaceutical production facility. * Demonstrated project management skills * Experience with SAP * Experience with MES or other SAP interfacing Business Systems * APICS CPIM certification * Able to organize large sets of electronic data in spreadsheets and databases. * Knowledge and practical application of Lean and/or Six Sigma methodology preferred. * SQL statement scripting competency preferred. Work Environment/Physical Demands/Safety Considerations * Extensive mouse and keyboard activities in office setting. * Job descriptions are not intended, and should not be construed, to be all-inclusive lists of all responsibilities, skills, efforts, or working conditions associated with a job. While this description is intended to be an accurate reflection of the job requirements, management reserves the right to modify, add, or remove duties and to assign other duties as necessary. Relocation benefits are not available for this posting The expected salary range for this position based on the primary location of California is $98,000 (min) - $140,000 (mid) - $182,000 (max) annual. 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 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.

Patients are at the heart of everything we do. As part of our Medical Affairs team, you'll foster internal and external collaboration to generate and disseminate evidence-based clinical practices to help impact patient lives and advance the quality of care. Your scientific curiosity and passion for patients will help us grow our reach and develop innovative solutions for people fighting cardiovascular disease. Aortic stenosis & aortic regurgitation impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards' groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. How you will make an impact: * Oversee the reengineering and optimization of business processes and systems using Power Platform. Act as a Power Platform Subject Matter Expert and be seen as a Power Platform specialist * Configure and test Power Platform systems (Power Apps, Power Automate) to execute features, integration, and reporting * Evaluate and validate functional business requirements against business needs. Translate the needs of the business into Power Platform and Dataverse solutions * Identify root causes and provide guidance for resolutions for testing and validation of Power Platform processes and systems * Serve as liaison between team members and stakeholders in the area of responsibility. Lead efforts to reengineer and optimize business processes and systems * Provide design and architecture guidance to project teams to execute tactical projects / initiatives * Provide leadership and guidance to business CRM administrators on best practices * Provide platform guidance to team members on CRM and Power Platform solutions * Identify and recommend innovations that significantly enhance efficiency and effectiveness of business processes What you will need (Required): * Bachelor's Degree & a minimum of 8 years of experience in a digital Project Management, Product Management or Customer Success role OR equivalent related experience based on Edwards criteria * A minimum of 3 years hands-on experience with Power Apps (Canvas and Model-driven applications) * A minimum of 3 years experience with Power Automate (Cloud flows, Desktop flows, Business process flows) * A minimum of 2 years experience with Microsoft Dataverse (data modeling, security, business rules) What else we look for (Preferred): * Stay current with latest platform features * Microsoft Power Platform certifications (PL-200, PL-400 preferred) * Proven successful project management skills * Extensive knowledge of own area within the organization while contributing to the development of new concepts, techniques, and standards * Extensive knowledge in at least discipline (e.g. Power Platform ALM and solution management) * Substantial technical knowledge with expertise in at least one technical language or data management system (e.g. Knowledge of Power BI for embedded analytics within Power Apps) * Extensive knowledge of platform ecosystem and integration points within Power Platform and governance * Represents leadership on sections of projects within a specific area interfacing with project managers and team. Ability to train and mentor team members on Power Platform best practices * Consult in project setting within specific sections of area (Experience integrating Power Platform with Azure services and Microsoft 365) Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California, the base pay range for this position is $118,000 - $167,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. #LI-Hybrid Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

Our Supply Chain team in San Diego is looking for a highly motivated and pro-active individual who possesses a strong work ethic and collaborative spirit to join our integrated team. As a Materials Specialist you will be focused on providing support to all our innovative programs. You will play a vital role to ensure availability of materials to our internal research, development, and manufacturing teams. Your effort will support Genentech in providing a safe and efficacious off-the-shelf treatment for patients with multiple myeloma, B cell malignancies, and multiple solid tumors. In this role you will be working cross-functionally and collaborating with individuals and functions both within Genentech and third parties, he/she will support, receiving, warehousing, shipping, and inventory management related tasks. The Opportunity Inspect and receive incoming deliveries at the receiving docks, gather packing slips and other documentation, and receive deliveries into the inventory system. Put away received materials in appropriate locations in the warehouse. Perform GMP receiving according to procedure and Good Documentation Practice (GDP). Issue materials to manufacturing in accordance with GMP procedures. Support manufacturing for after-hours product storage. Organize warehouse inventory locations for maximum efficiency. Ensure continuous flow of received materials in accordance with hazard, safety, and GMP guidelines. Perform cycle counts of materials in inventory. Support shipping of samples, general parcels, and manufacturing final product according to procedures. Stock all areas of the research laboratories with appropriate supplies as needed. Support the generation of data to be included in reports. Maintain files and documentation as related to all incoming and outgoing materials. Work well in a team environment with shared responsibilities. Additional responsibilities and duties as required. Who you are HS/AA or G.E.D. degree with 3 plus years of receiving, shipping and warehouse management experience (an equivalent combination of education and experience may be considered). Experience in a regulated environment (biotech, pharma, medical device, hospital or food manufacturing). Ability to work collaboratively, effectively, and across departments in a fast-paced work environment. Ability to perform multiple tasks simultaneously and accurately. Solid organizational skills with attention to detail are required. Strong communication skills Preferred GMP warehouse experience a plus. Proficiency with Microsoft Windows Computers running Google Workspace software. Familiarity with the laboratory environment and/or Shipping & Receiving environment a plus DOT Certification a plus Familiarity with Dangerous Goods and IATA Regulations a plus Work Environment/Physical Demands/Safety Considerations Physically capable of moving and lifting boxes up to 50lbs Physically capable and proficient in the operation of a pallet Jack Significant standing, walking, moving, carrying, bending, kneeling, reaching, handling, pushing, and pulling Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet, and body Relocation benefits not are available for this posting. The expected salary range for this position based on the primary location of San Diego, CA is $52,100 (min) - $74,400 (mid) - $96,700 (max) annual. 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 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.

** Doing now what patients need next... for a healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche. This role is based in Pharma Technical Operations Technology (PTT), an organization that is responsible for ensuring Pharma Technical Operations (PT) stays at the forefront of technology in our current and future facilities. PTT, composed of global MSAT and Engineering, plays a key role in leading seamless industrialization and thorough technical product management through integrating SHE, proactive maintenance, facility fitness, performance optimization, and scalable manufacturing processes and technologies in support of the manufacturing network. In this role, you will have the opportunity to shape the manufacturing network that delivers life saving medicines to patients. **The Opportunity** The Engineering Project Feasibility and Product Sourcing Leader within the PTT Asset Health & Future Assets (AHFA) group conducts early feasibility and product sourcing assessments for Global Engineering CapEx projects. This role ensures that capital investments and investments supporting sourcing decisions align with and enable the Pharma long-range plan. A core responsibility of this role is partnering closely with Network Strategy, Global Product & Supply Chain Management, manufacturing sites, and Finance to develop robust business cases that inform PT governance decisions regarding capital investments and product sourcings. + Secures buy-in from stakeholders and senior leadership, drives cross-functional alignment, and resolves issues within the engineering community and broader network for Global Engineering CapEx projects + Builds robust scenarios that model best- and worst-case outcomes and provide flexibility for informed decision-making in a dynamic business environment + Develops comprehensive business cases for capital projects, maintaining fiduciary responsibility for real estate and equipment assets + Assesses requirements for product launches, technology transfers, and capital investments; ensures assumptions across options are agreed upon and aligned with stakeholders + Conducts complex early feasibility assessments across sites and functions, collaborating closely with senior leaders, subject matter experts, and site engineering teams + Partners with the engineering community/network to apply technology standards that enable successful project outcomes and reduce business risk + Transitions completed early feasibility assessments to Project Initiation teams and contributes as an expert reviewer during project reviews **Who You Are** + Bachelor's degree in Engineering or related field + Minimum of 12 years of Pharmaceutical or Biotech experience, process engineering experience preferred + Minimum of 8 years of management leadership experience in a matrix organization + Experience in a complex global environment with CapEx project execution + International/global experience is strongly preferred + Flexibility for domestic and international travel as required Relocation benefits are not available for this posting. The expected salary range for this position based on the primary location of South San Francisco, California is $156,700 to $290,900. 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 (**************************************************** \#LI-PK1 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 (***************************************************************************************************** .

** At Genentech we are committed to fostering a culture of safety excellence, where the well-being of our employees is paramount. We are looking for a dedicated and experienced Safety Professional to join our team and contribute to our continuous improvement in safety performance. We are seeking candidates who possesses a practical, and specialized knowledge in industrial hygiene and its application within a biologics manufacturing environment. Additionally, you will play a strategic role that integrates EHS expertise directly into a specific operational or functional business unit; acting as the dedicated, single point of contact to ensure that safety is embedded into the function's daily activities and business processes. Working independently within broad guidelines and policies, this role impacts a range of operational, project, and service activities, receiving minimal guidance. The ideal candidate will be a self-starter with excellent communication skills, capable of influencing a strong safety culture across all levels of the organization. **The Opporutnity** + Hazard Identification and Risk Assessment: Solves problems by leading comprehensive workplace assessments and exposure evaluations. Exercises judgment based on the analysis of multiple sources of information (e.g., monitoring data, regulatory requirements, site history) to determine adverse health effects, which impacts a range of operational and service activities. + Specialized Exposure Monitoring and Sampling: Applies in-depth practical knowledge to design and execute monitoring and sampling strategies, ensuring compliance with standards. The results directly impact a range of operational activities. + Development of Control Methods: Recommends, designs, and implements engineering controls and other measures to mitigate hazards. Provides functional guidance on best practices for control implementation, and leads initiatives that impact project (e.g., capital improvements) and service activities. + Compliance and Regulatory Resource: Ensures and audits site compliance with occupational health and safety regulations, standards, and consensus guidelines (OSHA, Cal/OSHA, DOT, NIOSH, ACGIH). Acts as the primary resource for colleagues and management on changes in laws, working within broad guidelines and policies. + Health and Safety Training & Guidance: Develops and delivers specialized training for workers and managers on hazard awareness and controls. + Program Management: Owns site-level industrial hygiene programs (e.g., Hearing Conservation, Respiratory Protection, PPE), which are service activities impacting a range of operational groups. + Incident Management & Prevention: Responsible for leading the safety response within a key stakeholder assigned function. This involves facilitating root cause analyses for complex safety incidents and near-misses, and then collaboratively developing and implementing mitigation strategies and controls to prevent the recurrence of similar events. **Who you are** Knowledge/Skills/Competencies + Requires in-depth conceptual and practical knowledge in the specialized area of Occupational Health and/or Industrial Hygiene, including relevant regulations, codes, and consensus standards (OSHA, Cal/OSHA, DOT, NIOSH, ACGIH), along with hands-on experience in risk assessment, exposure monitoring, and the development of control solutions (engineering, administrative, PPE). + Problem-Solving and Judgment: Demonstrates the ability to solve complex problems, take a new perspective on existing solutions, and exercise sound judgment based on the analysis of multiple sources of information to make independent decisions. + Business Acumen and Integration: Has knowledge of best practices in EHS and understands how Industrial Hygiene integrates with other business areas (e.g., Operations, Engineering, Quality). + Teamwork: Acts as a resource for colleagues and provides functional guidance. Demonstrates the ability to jump in where needed, juggle multiple actions and drive to execution. + Demonstrates basic knowledge of related areas such as core safety and Environmental regulations, specifically those applicable to GMP and non-GMP biologics manufacturing environments. Education + You hold a Bachelor's Degree from an accredited 4-year college or university with a major in physical science, life science, engineering, occupational safety, or other relevant scientific field. Experience (minimum) + Minimum of 5 or more years of relevant work experience in Environmental, Health and Safety (EHS). + Previous experience in manufacturing and/or the biotechnology/pharmaceutical industry strongly preferred. Physical Requirements + Ability to walk, stand, and climb in industrial environments for extended periods. + Ability to wear required personal protective equipment (PPE), including safety glasses, hearing protection, hard hat, and safety shoes. + Ability to lift and carry up to 25 pounds occasionally. Relocation benefits are not available for this posting The expected salary range for this position based on the primary location of California is $98,600 (min) - $140,800 (mid) - $183,000 (max). 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 (**************************************************** 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 (***************************************************************************************************** .

** At Roche, we thrive to deliver more benefits to our patients as part of our 10-year Pharma vision. An integral part to achieving this vision is to deliver new and innovative data analytics solutions to our scientists across Pharma Technical Operations (PT). To do so, we have formed a new organization called PT Digital and Operational Excellence (PTE) with the aspiration to build industry-leading digital and lean operations across functions and our entire manufacturing footprint. **The Opportunity** PTE is the new organization that will catalyze the global development and execution of PT's Digital and Operational Excellence strategy to enable PT to realize our performance promises. We will build a strong cross-functional and inclusive community, put the power of data into the hands of our people, further develop the Lean and Digital skills across PT, and scale up our Digital and Advanced Analytics solutions, for the benefit of our colleagues and patients. We aim to activate data citizenship and digital mindset, revolutionize our FAIR data ecosystem and systems landscape, re-design excellent processes, and generate transformative insights. We collaborate closely with global functions to deliver impactful value to our patients. **What You'll Do** We in PTE work in partnership across major global business functions: PT-Quality, PT-Development, PT-Regulatory, PT-Manufacturing, establishing and implementing an overall Digital / Technology strategy and drive the delivery and scale of key data & digital solutions in support of our vision. This role is responsible for driving value realization and sustainability through the delivery of key digital initiatives and use cases across sites and Business Units. You will partner with customers across IT and PT functions to architect the planning, execution, and sustainment of digital solutions to achieve the PT Digital Aspirations. + Leads cross functional and cross site team workshops to solve complex digital and process challenges. + Identify and quantify high value processes with low to moderate investment and associated digital solutions for business case discussions. + Leverages sophisticated analytical thought to exercise judgement and identify innovative solutions. + Lead or co-lead process improvement activities with site and global OE partners - Maps business processes, apply LEAN principles, recommends process improvements to best fit digital solutions. + Communicates difficult concepts and negotiates with others to adopt a different point of view. + Interprets internal business challenges and recommends best practices - people, process, tool use - to improve the adoption and sustained value of digital products and services. + Proactively seeks external learnings and solutions to serve as options to complex challenges. + Coaches sites and business partners to develop similar expertise and skills. + Ensure scalability across global footprint. + Facilitate solution shaping process across PTx for data and digital products. + Build ecosystem of partners around strategic pillars + Coordinate the build-up of capabilities. + Coach teams that are developing and deploying digital use cases (share best practices, agile ways of working, ensure full impact capture & coordination between different initiatives). + Support build-up and management of a digital community that's focused on value realization. + Other duties as needed to support data management, workforce strategy, product delivery, support strategy, partnership and collaboration with IT and other PTx functions. **Who You Are** Do you bring experience (7 or more years) in architecting and implementing digital transformations, preferably in the pharma industry and are looking for an impactful role? We are seeking an individual with excellent knowledge of the pharma data ecosystem, informatics systems, tools, and techniques with a focus on the customer. This entails a good understanding of the customers' business, challenges, and goals in a manufacturing and operations environment. Further competences and qualifications: + BS in Science or Engineering Field with a minimum of 10 years of related experience. MS preferred. + Focus on results and proactive in identifying solutions. + Skilled in managing cross-functional partner relationships in a complex organization. + Ability to inspire and lead cross-functional project teams + Strategic and analytical thinking. Relocation benefits are not available for this posting. The expected salary range for this position based on the primary location of Hillsboro, OR is $131,000 - $243,400. 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 (****************************************************** \#LI-PK1 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 (***************************************************************************************************** .

** A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Genentech! The newly formed Genetic Medicine Technology group in gRED (Genentech Research and Early Development) is redefining the future of cell and gene therapies. Our proprietary non-viral gene delivery and gene editing platforms, including lipid nanoparticles (LNPs), piggy Bac and Cas-CLOVER, enable the development of next-generation CAR-T therapies with the potential to cure cancer and genetic diseases. We are seeking a highly motivated leader with a strong technical background in nanoparticle and LNP-mediated nucleic acids drug delivery. This person will join a dynamic and talented research team advancing non-viral therapies. This individual will direct efforts in developing novel non-viral drug delivery vehicles by overseeing the nanoparticle/nanotechnology function, working closely with the head of GMT. This individual will collaborate directly with immunology, bioanalytical, molecular biology, and pharmacology functions at Genentech San Diego to advance both platform and pipeline programs. This individual will also collaborate broadly with Genentech San Francisco and Roche research and innovation sites. The ideal candidate will have deep technical expertise with LNPs and chemistry, with additional expertise in pre-clinical models, xenographs, and T cell biology/manipulation. **The Opportunity** + Lead all research efforts for nanoparticle formulation, analytical characterization, and primary functional evaluation. + Discover and optimize applications of novel lipids from diverse structural families for LNP-mediated delivery of nucleic acid payloads. + Co-lead screening efforts, in vitro and in vivo, working closely with molecular and in vivo pharmacology groups, to identify novel LNP formulations for optimal tissue/cell delivery. + Collaborate with diverse groups across the organization, including those representing cell therapy, vector engineering, pharmacology, translational biology, immuno-oncology, CMC, process development, and small molecule subject matter experts. + Study fundamental mechanisms of action including LNP circulation, cellular uptake, endosomal escape, and specific behaviors unique to a particular payload class. + Lead efforts to advance platform development for an in vivo therapeutic application of an LNP modality from concept through clinical validation. + Analyze and interpret complex datasets, prepare clear reports, and present findings in internal program meetings, cross-functional reviews, and governance forums. + Lead and contribute to external publications, conference abstracts, and patent filings relevant to LNP development for autoimmune, neurology, and oncology indications. **Who you are** + Ph.D. in chemistry, engineering, bioengineering, nanotechnology, material science or a related field with 15+ years of relevant industry and academic experience. A strong background in DNA delivery is a plus. + Experience successfully advancing a candidate to IND-enabling studies is required. + Proven expertise in nanoparticle science, especially LNP delivery systems and non-viral gene transfer/delivery. + Strong data analysis skills and familiarity with design of experiments statistical analyses for process optimization, using software such as JMP statistical tools. + Familiarity with nucleic acids chemistry and molecular biology is highly desirable. + A background working with targeted si RNAs, liposomes, or ADCs is valued. + Experience working in the immunology space and with T cells is a plus, though not required. + Excellent communication, organizational, and leadership skills. + Passionate for people development with a proven track record in developing staff and high performing teams + Exceptional people and team management skills Relocation benefits are available for this job posting. The expected salary range for this position based on the primary location of San Diego, CA is $185,900 - $345,200. 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 (**************************************************** 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 (***************************************************************************************************** .

** We are seeking a skilled professional to oversee the development, maintenance, and advancement of the SAP system recipe and master data, supporting Oceanside Production. As a subject matter expert and liaison, the position involves collaborating with internal and external stakeholders to ensure seamless integration between SAP S4H, OMP, MES, LIMS, and paper-based systems. The ideal candidate will excel at leading cross-functional teams, identifying and solving challenges, driving measurable business results, and proactively proposing improvements. Additionally, this role requires engaging with the global business process management community and handling project and system implementation challenges with both teamwork and independent initiative. A strong understanding of broader manufacturing and operational functions-including Drug Substance and Drug Product processes, materials management, production scheduling, capacity management, and quality-is essential. **The Opportunity** The Senior Business Systems Analysts will be responsible for collaborating with suppliers/customers to identify, create, and manage SAP Master Data in order to enable planning and Make-Assess-Release processes. As a key team member on Business Systems Integration (BSI) Team, responsibilities of this position include: + Applies extensive theoretical and cross-functional expertise in the context of company objectives to independently address complex problems. Determines methods and procedures on new assignments. + Work is performed under limited direction. Establishes own work priorities and timeliness. May provide guidance and coordinate work activities of other personnel. + Develops solutions to a variety of complex problems and initiatives. Exercises judgement in selecting methods and techniques and evaluation criteria for obtaining results. Works on complex issues where analysis of situations or data, requires an in-depth evaluation of variable factors including inter-organizational impact. Regularly exercises independent judgment and discretion regarding matters of significance. + Interacts with senior internal and external personnel on significant matters. + Represents organization as a prime contact on initiatives and projects. + Develop SAP Master data for load into system. Coordinate and lead Data Definition and Deployment efforts with site and network representatives. + Adhere to change management processes to ensure data is deployed and maintained in a controlled manner. + Provide analysis and reporting of data to manage key performance indicators and Class A metrics. + Translate business requirements to technical specifications and collaborate with key stakeholders to complete requests. + Provide training on usage, enhancements and changes to business systems + Leads cross-functional teams in the identification and implementation of improvement initiatives, using LEAN techniques. **Who you are** + B.A. or B.S. degree with 2 to 4 years work experience in the pharmaceutical, biopharmaceutical or related industry, or a Master's Degree with 0-2 years relevant experience, or an equivalent combination of education and experience. + Experience with ERP systems Recipe Development, Master Data. + Full use and application of basic Supply Chain/Business Process/cGMP theories, principles, and techniques. + Possess strong analytical skills and understanding of systems and technical designs. + Knowledge of cGMPs and equivalent regulations + Demonstrated ability to effectively interpret Quality standards for implementation. + Demonstrated ability to manage small projects from initiation to delivery to achieve measurable results. + Demonstrated ability to independently evaluate situations and propose potential solutions. + Demonstrated ability to communicate clearly and professionally both in writing and verbally. + Demonstrated ability to quickly learn a broad range of skills + Flexibility in problem solving and work hours to meet business objectives and dynamic. + production requirements Preferred: + Experience in GMP Biopharmaceutical production facility. + Demonstrated project management skills + Experience with SAP + Experience with MES or other SAP interfacing Business Systems + APICS CPIM certification + Able to organize large sets of electronic data in spreadsheets and databases. + Knowledge and practical application of Lean and/or Six Sigma methodology preferred. + SQL statement scripting competency preferred. Work Environment/Physical Demands/Safety Considerations + Extensive mouse and keyboard activities in office setting. + Job descriptions are not intended, and should not be construed, to be all-inclusive lists of all responsibilities, skills, efforts, or working conditions associated with a job. While this description is intended to be an accurate reflection of the job requirements, management reserves the right to modify, add, or remove duties and to assign other duties as necessary. Relocation benefits are not available for this posting The expected salary range for this position based on the primary location of California is $98,000 (min) - $140,000 (mid) - $182,000 (max) annual. 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 (**************************************************** 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 (***************************************************************************************************** .