{"id":1807567,"url":"https://alion.io/job/capgemini-senior-manager-extractables-leachables-life-sciences","title":"Senior Manager Extractables & Leachables | Life Sciences","company":{"id":145,"name":"Capgemini","domain":"capgemini.com","url":"https://alion.io/company/capgemini","size_band":"5000+","is_staffing_agency":false,"employer_type":"services","is_intermediary":false,"listed_via":null,"ats_vendor":"Career site","truth_index":{"grade":"B","score":80,"open_postings":1732,"ghost_share":0,"stale_share":0.783,"repost_share":0.005,"time_to_fill_p50_days":28,"computed_at":"2026-10-21T05:46:15Z"}},"role":"Science & Research","role_family":"Science & Research","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":["Diegem, Belgium"],"countries":["BE"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":54000,"max_usd":122000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":1403},"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"AWS","optional":false}],"status":"live","first_seen_at":"2026-09-09T14:42:20Z","employer_posted_date":"2026-09-09","last_verified_at":"2026-10-21T11:32:10Z","board_verified":true,"closed_at":null,"days_open":41,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":41},"description":"At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world’s most innovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as they provide unique R&D and engineering services across all industries. Join us for a career full of opportunities. Where you can make a difference. Where no two days are the same.\nYour Role\nWe are looking for a Senior Manager, Extractables & Leachables (E&L) to join our growing life sciences team. In this senior scientific leadership role, you will provide expert technical oversight across complex E&L and chemical characterization programs, supporting a wide range of pharmaceutical and medical device products. You will be a key interface between analytical science, regulatory strategy, and cross-functional teams, driving both technical excellence and operational performance.\nIn this role you will play a key role in:\nProviding technical oversight for extractables and leachables programs supporting inhalation products, transdermal systems, injectables, medical devices, and drug-device combination products, including leading chemical characterization studies utilizing advanced techniques such as GC-MS, LC-MS, HRMS, and ICP-MS.\nLeading the development, qualification, validation, transfer, and lifecycle management of analytical methods, while driving implementation of new analytical technologies and guiding investigations involving unknown compound identification and complex analytical challenges.\nServing as a subject matter expert in global regulatory expectations for E&L and chemical characterization programs, including USP, ISO 10993, PQRI, FDA, EMA, and nitrosamine guidance, supporting product submissions, regulatory inspections, and customer audits.\nLeading analytical programs responsible for the qualification and clearance of plastic, elastomeric, and other critical components used in drug delivery systems, partnering with global manufacturing sites to ensure efficient testing and release of critical materials.\nDriving continuous improvement and operational excellence initiatives using Lean, Six Sigma, or equivalent methodologies, while collaborating cross-functionally with Manufacturing, Regulatory Affairs, Toxicology, Quality Assurance, and Commercial teams to support strategic decision-making.\nYour Profile\nA Bachelor's degree or higher (Master's or PhD preferred) in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, Chemical Engineering, or a related scientific discipline, with a minimum of 10 years of analytical chemistry experience within pharmaceutical, medical device, combination product, or regulated healthcare industries.\nDemonstrated expertise in extractables and leachables, chemical characterization, and trace-level analytical testing, with extensive hands-on experience with chromatographic and mass spectrometry platforms including GC-MS and LC-MS.\nMinimum 5 years of leadership experience managing scientific or laboratory teams, with a strong understanding of cGMP laboratory operations, quality systems, and regulated product development environments.\nStrong knowledge of global regulatory frameworks including USP, ISO 10993-series, PQRI OINDP recommendations, and applicable FDA and EMA expectations, with experience supporting regulatory submissions and health authority interactions.\nExcellent technical writing, data interpretation, and communication skills, with the ability to present complex scientific information clearly to both technical and executive audiences, combined with strong cross-functional collaboration capabilities.\nWhat you'll love about working here\nOwn your Growth: Free access for all to world-class learning assets and curated programs from Harvard Business Review, Coursera, Pluralsight, Udemy, Microsoft, AWS, Google and many more. Our engineering academy offers more than 60,000 hours of training to support your professional development.\n\nConnect for Success: Our professional communities foster career development and strengthen Capgemini's capabilities across various domains. You will also benefit from mentoring programs to stimulate your professional growth.\n\nLead the Change: As a global leader in engineering services, Capgemini Engineering combines its broad industry knowledge and cutting-edge technologies to help our clients develop the smart products and services of tomorrow.\n\nCapgemini is a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering, all fueled by its market leading capabilities in AI, generative AI, cloud and data, combined with its deep industry expertise and partner ecosystem.","description_format":"text","description_chars":5252,"description_truncated":false,"requirements":{"experience_years_min":10,"management_years_min":5,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":true},"security_clearance":false,"languages":[]},"benefits":["Mentoring programs","Professional development"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Systems Integrators","Management Consulting","Engineering Services"],"lifecycle":[{"event":"open","at":"2026-10-03T19:29:46Z"}],"visa":[],"liveness":{"score":22,"band":"cold","label":"Long shot","p_open":1,"p_active":0.497,"p_room":0.44,"age_days":41,"expected_fill_days":28,"reasons":["conf:3","stale_co","velocity","win:tail","crowd:brand"],"computed_at":"2026-10-21T05:46:15Z"},"pay":null,"html_url":"https://alion.io/job/capgemini-senior-manager-extractables-leachables-life-sciences","json_url":"https://alion.io/job/capgemini-senior-manager-extractables-leachables-life-sciences.json","meta":{"generated_at":"2026-10-21T13:11:43Z","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":18715,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-22T00:00:00Z"}},"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":145},"rest":"https://alion.io/mcp/rest/get_company?id=145"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fcapgemini-senior-manager-extractables-leachables-life-sciences"},{"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%2Fcapgemini-senior-manager-extractables-leachables-life-sciences"},{"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%2Fcapgemini-senior-manager-extractables-leachables-life-sciences"},{"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/capgemini-senior-manager-extractables-leachables-life-sciences\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fcapgemini-senior-manager-extractables-leachables-life-sciences"}]}