{"id":3241402,"url":"https://alion.io/job/genentech-senior-manager-analytical-sciences-and-technology-cvrm","title":"Senior Manager, Analytical Sciences and Technology, CVRM","company":{"id":1757810,"name":"Genentech","domain":"gene.com","url":"https://alion.io/company/gene-com","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":75,"open_postings":29,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":null,"computed_at":"2026-10-27T05:46:45Z"}},"role":"Biotech","role_family":"Biotech","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Holly Springs, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":120100,"max":223100,"currency":"USD","period":"year","gross":null,"usd_annual":223100},"salary_estimate":null,"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-09-28T00:00:00Z","employer_posted_date":"2026-09-28","last_verified_at":"2026-10-27T15:11:07Z","board_verified":true,"closed_at":null,"days_open":29,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":29},"description":"Welcome to Holly Springs, North Carolina- home to Roche/Genentech's largest-ever investment: a $2B greenfield start-up where next-generation technology, high-performing teams and Operational Excellence converge to create the global standard for high-volume, highly-efficient Drug Product manufacturing. \nThe facility's core is defined by Innovation - leveraging advanced automation, robotics, digital tools, real-time data analytics, and simple, streamlined processes to produce the highest quality medicines. This plant meets today’s demand for CVRM (Cardiovascular, Renal, and Metabolism) medicines and is scalable to grow with the portfolio, which focuses on next-generation metabolic medicines specifically targeting the global obesity epidemic and Type 2 diabetes. This is a fast-paced, entrepreneurial environment with a high-level of accountability, with planned launch in 2028.\nAre you a problem-solver and change-agent who thrives in a Team environment, eager to tackle the most complex manufacturing challenges? If so, this is a once-in-a-lifetime opportunity to launch a state-of-the-art facility from the ground-up and shape the culture of our organization for the next generation.\nJoin us in Holly Springs, where you won't just build a plant-you will build the future of medicine.\nThe Opportunity:\nThe Holly Springs Quality Control Team is seeking an experienced and dynamic leader to establish and head our Analytical Sciences and Technology team.\nIn this critical role, you will build a highly effective and engaged organization capable of delivering safe, compliant, and efficient testing for our CVRM (Cardiovascular, Renal, and Metabolism) products manufactured at the Holly Springs site. Initially, you will focus on laboratory start-up activities-establishing QC methods to support facility, utility, and process qualifications-before pivoting to method lifecycle management and ongoing support of routine QC operations to include QC Quality records and stability/sampling.\nLeadership:\nYou will champion a proactive quality culture built on psychological safety and transparent communication-empowering your team to speak up, simplify processes, and take personal accountability for owning quality. \nYou will drive a proactive safety culture by fostering Behavior-Based Safety (BBS) principles and ensuring strict compliance with site safety processes and regulatory standards.\nYou will foster a high-performing, engaged lab culture by practicing Lean Leadership, providing active coaching, and embedding continuous improvement into daily operations. \nYou will partner with the global network to harmonize QC standards and ensure seamless execution and compliance across site operations.\nTechnical and functional tasks:\nYou will author, review, and approve critical technical, scientific, and compliance documents (e.g., test methods, validation/stability protocols, SOPs).\nYou will establish key operational performance measures (KPIs) with a focus on Compliance, Right-First-Time (RFT) execution and continuous improvement to meet business objectives.\nYou will own Quality Management System (QMS) records, including investigations, deviations, CAPAs, and change controls.\nYou will participate in the identification, evaluation, and implementation of new technologies in alignment with business objectives or regulatory requirements. \nYou will have responsibility for strategic projects to support execution of QC network strategy.\nYou are experienced in presenting QC topics during regulatory inspections and maintaining a continuous state of audit readiness across QC operations. \nWho you are:\nYou hold a B.S. or M.S. degree (Science related discipline) with a minimum of 8 years of experience in pharmaceutical or biopharmaceutical manufacturing. This includes at least 3 years of direct experience in QC operations at a finished drug product commercial manufacturing site.\nYou have extensive technical knowledge of analytical methods, laboratory instrumentation, with proven experience in analytical method validation, qualification, and transfer within the pharmaceutical or biopharmaceutical industry.\nYou have experience in stability program ownership for a commercial manufacturing site. \nYou have in-depth working knowledge of cGMP operations, ICH guidelines, and global Health Authority regulatory requirements (FDA, EMA, etc.). \nYou have proven technical leadership capabilities and demonstrated project management skills, with a track record of effectively managing workload distribution, timelines, and competing priorities.\nYou have exceptional communication skills with the demonstrated ability to inspire, motivate, and coach a team while collaborating effectively with internal cross-functional groups, global partners, suppliers, and external customers.\nYou have extensive experience in deviation investigation.\nPreferred:\nExperience in a greenfield project.\nHands-on knowledge or oversight of Medical Device Functionality testing (e.g., autoinjectors, pen injectors).\nExperience in both Physical Chemistry and Microbiological Method Lifecycle Management.\nExperience in method establishment and oversight at contract testing laboratories.\nRelocation assistance is available for this role.\nThe expected salary range for this position based on the primary location for this position of Holly Springs, North Carolina is $120,100 - $223,100. 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.\nLink to Benefits\nGenentech 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.\nIf 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.","description_format":"text","description_chars":6240,"description_truncated":false,"requirements":{"experience_years_min":8,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Relocation assistance"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":true,"industries":["Drug Discovery","Biologics & Biosimilars","Oncology Therapeutics","Neurology & CNS Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-25T16:16:16Z"}],"visa":[],"liveness":{"score":32,"band":"fade","label":"Fading","p_open":1,"p_active":0.573,"p_room":0.55,"age_days":29,"expected_fill_days":26,"reasons":["conf:1","stale_co","velocity","win:tail","comp:brand"],"computed_at":"2026-10-27T05:46:45Z"},"pay":{"stated_usd_annual":223100,"is_top_pay":true},"html_url":"https://alion.io/job/genentech-senior-manager-analytical-sciences-and-technology-cvrm","json_url":"https://alion.io/job/genentech-senior-manager-analytical-sciences-and-technology-cvrm.json","meta":{"generated_at":"2026-10-27T19:33:43Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":10193,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-28T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":1757810},"rest":"https://alion.io/mcp/rest/get_company?id=1757810"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fgenentech-senior-manager-analytical-sciences-and-technology-cvrm"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fgenentech-senior-manager-analytical-sciences-and-technology-cvrm"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fgenentech-senior-manager-analytical-sciences-and-technology-cvrm"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/genentech-senior-manager-analytical-sciences-and-technology-cvrm\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fgenentech-senior-manager-analytical-sciences-and-technology-cvrm"}]}