{"id":2997107,"url":"https://alion.io/job/werfen-senior-manager-reagent-and-assay-development","title":"Senior Manager, Reagent and Assay Development","company":{"id":1839823,"name":"Werfen","domain":"werfen.com","url":"https://alion.io/company/werfen","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"iCIMS","truth_index":null},"role":"MedTech","role_family":"MedTech","seniority":"senior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"explicit","locations":["Norcross, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":99000,"max_usd":186000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":50},"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Design Controls","optional":false},{"name":"Human Factors Engineering","optional":false},{"name":"Verification & Validation","optional":false}],"status":"live","first_seen_at":"2026-10-21T11:10:27Z","employer_posted_date":"2026-10-21","last_verified_at":"2026-10-30T17:05:25Z","board_verified":true,"closed_at":null,"days_open":9,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":9},"description":"Introduction\nWerfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.\nOur success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.\nOverview\nJob Summary\nThe Senior Manager, Reagent & Assay Development will lead a team of scientists in the scientific and operational development of immunohematology in-vitro diagnostic (IVD) reagents, assays, and supporting technologies from concept through commercialization. This role is responsible for managing cross-functional development activities related to blood grouping, antibody screening/identification, compatibility testing, and transfusion diagnostics while ensuring compliance with applicable regulatory and quality requirements.\nThe ideal candidate combines deep technical expertise in immunohematology and assay development with strong leadership, project management, and commercialization experience within regulated IVD environments.\nResponsibilities\nKey Accountabilities\nLead the design, development, optimization, and validation of immunohematology reagents and assays for transfusion diagnostic applications. \nOversee development activities for products including:ABO/Rh typing reagents \nAntibody screening and identification assays \nDAT/IAT assays \nRare antigen detection reagents \nAutomation-compatible reagent systems \n\nDrive assay performance improvements related to sensitivity, specificity, stability, reproducibility, and robustness. \nEstablish scientific strategies for reagent formulation, antibody characterization, antigen sourcing, and assay controls. \nEvaluate emerging technologies and methodologies applicable to immunohematology diagnostics. \nProvide technical leadership during troubleshooting, root cause investigations, and product performance evaluations.\nBuild, mentor, and lead a multidisciplinary team of scientists and research associates. \nEstablish departmental goals, development priorities, and performance metrics. \nFoster a collaborative, innovative, and quality-focused culture. \nManage resource allocation, staffing plans, budgets, and external partnerships.\nLead projects through the full product lifecycle from feasibility through verification, validation, transfer to manufacturing, and post-market support. \nEnsure adherence to design control requirements and stage-gate development processes. \nCollaborate with Manufacturing, Quality, Regulatory Affairs, Clinical Affairs, Marketing, and Supply Chain teams. \nSupport technology transfer and manufacturing scale-up activities.\nPerforms other duties and responsibilities as assigned\nReasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.\nNetworking/Key relationships\nPartner with clinical and commercial teams to align product development with customer and market needs.\nInterface with key opinion leaders, blood centers, hospitals, and external collaborators. \nPresent technical updates to senior leadership and external stakeholders.\nQualifications\nMinimum Knowledge & Experience required for the position:\nPh.D., M.S., or equivalent advanced degree in Immunology, Hematology, Clinical Laboratory Science, Biochemistry, Molecular Biology, or related scientific discipline preferred. \nSBB (Specialist in Blood Banking) certification strongly preferred.\n10+ years of experience in IVD, biotech, diagnostics, or transfusion medicine industries. \n5+ years of leadership or people management experience. \nDemonstrated expertise in immunohematology assay and reagent development. \nExperience developing regulated IVD products from concept to commercialization. \nStrong knowledge of transfusion medicine principles and serological testing methodologies. \nExperience with automated diagnostic platforms preferred. \nManagement has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.\nSkills & Capabilities:\nDeep understanding of: Immunoassay technologies and techniques, Red cell serology, Monoclonal and polyclonal antibody technologies, Reagent formulation and stabilization Assay verification and validation, Statistical data analysis and experimental design. \nFamiliarity with analytical performance studies including precision, interference, sensitivity, specificity, and stability testing. \nKnowledge of risk management principles and usability engineering is preferred.\nExperience supporting FDA submissions and international regulatory approvals. \nKnowledge of blood bank automation systems and workflow integration. \nExperience working with global development or manufacturing teams. \nTrack record of innovation and successful product launches in immunohematology diag-nostics.\nTravel requirements:\nMinimal Travel Required: \nClosing\nIf you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.\nWerfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact  for assistance.\nWe operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.\nwww.werfen.com","description_format":"text","description_chars":6480,"description_truncated":false,"requirements":{"experience_years_min":10,"management_years_min":5,"team_size_min":null,"manages_managers":false,"education":{"level":"phd","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Drug Discovery","Diagnostic Tests & IVD","Medical Supplies & Consumables"],"lifecycle":[{"event":"open","at":"2026-10-21T11:10:27Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 1","filings_12m":1,"filings_prev_12m":0,"green_card_filings_12m":0,"median_offered_wage_usd":82500,"route":null,"cap_exempt":false,"checked_at":"2026-10-29T16:27:21+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)"],"filings_for_role_12m":0}],"liveness":{"score":67,"band":"ok","label":"Likely open","p_open":1,"p_active":0.856,"p_room":0.788,"age_days":8,"expected_fill_days":12,"reasons":["conf:2","velocity","win:late"],"computed_at":"2026-10-30T05:48:23Z"},"pay":null,"html_url":"https://alion.io/job/werfen-senior-manager-reagent-and-assay-development","json_url":"https://alion.io/job/werfen-senior-manager-reagent-and-assay-development.json","meta":{"generated_at":"2026-10-30T20:41:59Z","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":10796,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-31T00:00:00Z"}},"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":1839823},"rest":"https://alion.io/mcp/rest/get_company?id=1839823"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fwerfen-senior-manager-reagent-and-assay-development"},{"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%2Fwerfen-senior-manager-reagent-and-assay-development"},{"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%2Fwerfen-senior-manager-reagent-and-assay-development"},{"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/werfen-senior-manager-reagent-and-assay-development\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fwerfen-senior-manager-reagent-and-assay-development"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":2997107}},{"tool":"search_jobs","arguments":{"company":"werfen.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":2997107},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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