{"id":1644155,"url":"https://alion.io/job/precigen-site-microbiologist","title":"Site Microbiologist","company":{"id":3188444,"name":"Precigen","domain":"precigen.com","url":"https://alion.io/company/precigen","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"ADP","truth_index":null},"role":"Science & Research","role_family":"Science & Research","seniority":"staff","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"inferred","locations":["Germantown, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":140000,"max":170000,"currency":"USD","period":"year","gross":null,"usd_annual":170000},"salary_estimate":null,"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-09-17T20:51:00Z","employer_posted_date":"2026-09-17","last_verified_at":"2026-10-13T16:34:20Z","board_verified":true,"closed_at":null,"days_open":27,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":27},"description":"Precigen is a commercial and clinical-stage biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy and gene therapy products designed to harness the power of a patient’s own immune system to selectively target and kill cancer cells. We are on a rapid growth trajectory and have a highly energized and accomplished team. We are seeking a highly motivated individual to join us as a Site Microbiologist.\nThe Site Microbiologist serves as the site's microbiology and contamination control subject matter expert and is responsible for leadership, governance, and continuous improvement of the site's Contamination Control Strategy (CCS). This role provides technical oversight of environmental monitoring, aseptic processing, cleanroom qualification, facility microbiology, microbiological investigations, and contamination control programs supporting clinical and commercial manufacturing operations. As the site lead for microbiological quality and contamination control, the Site Microbiologist works cross-functionally with Manufacturing, Quality Assurance, Engineering, and Validation to ensure a state of environmental and microbiological control, proactively identify and mitigate risks, and maintain compliance with applicable global regulatory requirements and industry best practices. The Site Microbiologist is also responsible for driving continuous improvement of microbiological methods, environmental monitoring programs, analytical controls, and laboratory processes through the application of scientific, risk-based, and innovative approaches that enhance quality, robustness, and operational efficiency.\nDUTIES AND RESPONSIBILITIES:\nOwn, maintain, and continuously improve the site’s Contamination Control Strategy (CCS).\nServing as the site microbiology and contamination control SME, lead periodic governance, risk assessment reviews, and contamination control culture initiatives.\nProvide microbiological oversight and routing floor support for clinical and commercial manufacturing operations, including assessment of aseptic processing practices, operator behaviors, material and equipment flows, facility controls, microbiological risks, and implementation of corrective actions as appropriate.\nProvide technical oversight of environmental monitoring, utility monitoring, process monitoring, environmental isolate identification, and microbiological trending programs, including review of EM reports, adverse trends, contamination control metrics, performance indicators, and overall effectiveness of contamination control measures.\nLead or support microbiology-related investigations, root cause analyses, risk assessments, deviations, CAPAs, and quality system activities involving environmental monitoring excursions, contamination events, sterility assurance concerns, utility excursions, and emerging microbiological risks.\nReview and assess cleaning and disinfection programs, disinfectant effectiveness data, disinfectant qualification studies, and contamination control effectiveness. \nProvide microbiological support for qualification, validation, change control, process validation, technology transfer, and facility, utility, equipment, and process modifications, including assessment of microbiological risks associated with manufacturing and operational changes.\nPartner with Manufacturing, QA, Engineering, Validation, and Regulatory Affairs to ensure compliance with applicable regulatory requirements and industry best practices, support audits and inspections, and present microbiology and contamination control data during quality and regulatory reviews.\nDrive continuous improvement of microbiological methods, EM programs, analytical control strategies, contamination control techniques, laboratory operations, and regulatory compliance through technical leadership, technology evaluation, document management, training, and mentoring. \nPerform other duties as assigned.\nEDUCATION AND EXPERIENCE:\nPh.D. or Master's Degree in Microbiology, Biological Sciences, Pharmaceutical Sciences, Biotechnology, or a related scientific discipline. \nMinimum of ten (10) years of experience in the pharmaceutical, biotechnology, biologics, cell therapy, or gene therapy industry. \nMinimum of five (5) years of experience supporting sterile or aseptic manufacturing operations. \nDemonstrated experience leading environmental monitoring, contamination control, and microbiological quality programs within a GMP-regulated environment, including development and maintenance of Contamination Control Strategies (CCS), environmental monitoring programs, microbiological data trending, microbial identification systems, and environmental isolate management.\nExtensive knowledge of cGMP, EU GMP, FDA regulations, ICH guidance, and global regulatory requirements with experience supporting regulatory inspections, audits, and responses to regulatory observations.\nDemonstrated experience leading microbiological investigations, root cause analyses, deviation management, CAPA implementation, and risk management activities, including authoring and reviewing SOPs, protocols, reports, risk assessments, technical documents, and regulatory submissions.\nExperience supporting cleanroom classification and qualification, EMPQ, facility qualification, cleaning and disinfection programs, disinfectant qualification, and contamination control activities.\nExperience evaluating and implementing improvements to microbiological methods, environmental monitoring programs, analytical control strategies, and emerging microbiological technologies, with demonstrated ability to lead cross-functional teams and influence decision-making across Quality, Manufacturing, Engineering, and Validation teams.\nPrior experience in clinical and commercial manufacturing environments preferred. \nDESIRED KEY COMPETENCIES:\nExpert knowledge of pharmaceutical microbiology, contamination control, aseptic processing, and environmental monitoring programs. \nStrong leadership skills with the ability to drive and continuously improve the site's Contamination Control Strategy (CCS) and microbiological quality systems. \nDemonstrated ability to apply scientific and risk-based decision making to investigations, contamination control, environmental monitoring, and process improvements. \nProven track record of identifying and implementing innovative solutions that improve analytical controls, laboratory efficiency, compliance, and operational performance. \nExcellent analytical, problem-solving, technical writing, and communication skills. \nAbility to effectively influence and collaborate with cross-functional teams, including Manufacturing, Quality Assurance, Engineering, Validation, and Regulatory Affairs. \nStrong organizational and project management skills with the ability to manage multiple priorities in a fast-paced environment. \nHigh degree of integrity, professionalism, accountability, and commitment to quality, compliance, and patient safety. \nProficiency with Microsoft Office and electronic quality management systems. \nSelf-motivated, adaptable, and capable of promoting a strong culture of contamination control, continuous improvement, and operational excellence across the organization.\nOccasional work outside of normal business hours, including evenings, weekends, and holidays, may be required based on business needs.\nEOE MFDV","description_format":"text","description_chars":7397,"description_truncated":false,"requirements":{"experience_years_min":10,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"master","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Cell & Gene Therapy"],"lifecycle":[{"event":"open","at":"2026-10-01T22:59:14Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 2","filings_12m":2,"filings_prev_12m":0,"green_card_filings_12m":0,"median_offered_wage_usd":77500,"route":null,"cap_exempt":false,"checked_at":"2026-10-03T21:08:04+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)"],"filings_for_role_12m":0}],"liveness":{"score":77,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.85,"p_room":0.9,"age_days":26,"expected_fill_days":52,"reasons":["conf:13","win:mid"],"computed_at":"2026-10-14T06:34:16Z"},"pay":{"stated_usd_annual":170000,"is_top_pay":true},"html_url":"https://alion.io/job/precigen-site-microbiologist","json_url":"https://alion.io/job/precigen-site-microbiologist.json","meta":{"generated_at":"2026-10-15T03:57:03Z","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 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