{"id":1813809,"url":"https://alion.io/job/polypore-sr-manager-cmc-analytical-development","title":"Sr. Manager, CMC Analytical Development","company":{"id":2254853,"name":"Polypore","domain":"polypore.com","url":"https://alion.io/company/polypore","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":75,"open_postings":4,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":null,"computed_at":"2026-10-09T06:01:00Z"}},"role":"Early Careers","role_family":"Early Careers","seniority":"senior","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Cary, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":150000,"max":160000,"currency":"USD","period":"year","gross":null,"usd_annual":160000},"salary_estimate":null,"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Microsoft Office","optional":false},{"name":"Outlook","optional":false}],"status":"live","first_seen_at":"2026-10-02T00:00:00Z","employer_posted_date":"2026-10-02","last_verified_at":"2026-10-10T01:38:43Z","board_verified":true,"closed_at":null,"days_open":8,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":8},"description":"The Asahi Kasei Group operates with a commitment of creating for tomorrow. Our business sectors,Materials, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment.\nAsahi Kasei Therapeutics is the global specialty pharmaceutical business of Asahi Kasei. We are a commercial-stage company committed to positively impacting health by expanding therapeutic options that improve the lives of patients around the world. Drawing upon our strong heritage of scientific innovation, we aim to help reshape care in transplantation, nephrology, immunology, infectious diseases and other underserved conditions.\nJob Description:\nThis position provides analytical support of the Company’s product portfolio and pipeline from early-stage development through post-approval requirements and works directly with the Company’s partners to ensure testing is compliant with Quality, Regulatory, and Company requirements, necessitating a high level of external communication and interaction as well as ability to manage multiple projects. The incumbent works on project teams to drive the growth and development the Company’s products, as well as with contract research/development/manufacturing organization (CRO/CDO/CMO) partners on study activities to meet established timelines and provide necessary scientific oversight for outsourced work on method development/re-development, qualification/validation, sample analysis, characterization, data delivery, and reporting.\nThe base compensation range for this role is $150-160K. Base Compensation is influenced by many factors including, but not limited to: time in the role, previous experience, skills, knowledge, performance, work requirements, internal equity, and business / economic conditions.”\nSummary of Key Responsibilities\nOversees conduct of all CMC testing (large molecule) at CRO/CDO/CMOs.\nOversees CMC method (large molecule) development, validation, qualification, and transfers at CRO/CDO/CMOs\nOversees CMC stability programs at CRO/CDO/CMOs.\nProvides expert review, assessment, and trending of CMC analytical data from CRO/CDO/CMOs.\nOversees characterization, qualification, and life-cycle management of reference materials.\nServes as technical lead for CMC analytical testing.\nManages CMC methods and specifications for release and stability.\nEfficiently communicates project tasks, deliverables, and timelines to external partners, ensuring that critical deadlines are agreed upon and met.\nAuthors appropriate documentation in a timely manner to support regulatory filings, including but not limited to IND, IMPD, NDA/BLA, and pre- and post-approval changes.\nAuthors, reviews, and/or approves all technical related protocols, SOPs, change controls, and reports, as needed, ensuring delivery of those reports to other Company departments (Manufacturing & Technical Operations, Clinical, Quality Assurance, Regulatory Affairs), external vendors, and/or license partners.\nSupports partners in all activities related to CMC analytical development.\nAssists in the department’s successful and efficient execution of departmental/area goals.\nSupports the Quality Assurance department in auditing activities of CRO/CDO/CMOs.\nPrepares for regulatory agency inspections, including pre-approval inspections at the Company’s facilities and key contractors’ facilities.\nStays abreast of scientific literature and regulatory guidelines pertinent to CMC analytical development and the therapeutic area(s) of the Company’s products.\nRequired Qualifications and Skills\nBS, MS or PhD in Analytical Chemistry, Biochemistry, or related field.\n10 years’ experience in CMC analytical in pharmaceutical testing environments.\nExtensive knowledge of development validation of CMC analytical methods.\nExtensive knowledge of CMC analytical techniques (e.g., HPLC, ligand binding assays, capillary electrophoresis, CCIT, endotoxin, process impurity methods, peptide mapping, and mass spectrometry).\nDemonstrated expertise in troubleshooting and resolution of CMC related laboratory investigations and deviations.\nKnowledge of requirements and strategy for regulatory submissions related to CMC development; this includes all analytical modules for drug substance and drug product (3.2.S and 3.2.P).\nDemonstrated ability to analyze and transform CMC data (release and stability) into knowledge.\nExtensive knowledge of ICH, market specific guidance, national pharmacopoeia, and industry workgroups related to CMC analytical development.\nDemonstrated ability to assess and act on programs of work to meet business goals.\nProficiency in Quality procedures (e.g., GMPs, including data integrity).\nDemonstrated consistency in applying and furthering scientific/technical concepts and techniques to resolve scientific/technical issues efficiently and effectively.\nEfficient time management, capable of multi-tasking and prioritization; structured and proactive work approach.\nExcellent interpersonal and communication (verbal and written); effective presentation skills to both internal and external audiences.\nProficiency in MS Office Suite (Outlook, Excel, Word, PowerPoint) and Adobe Pro.\nTravel Requirements: Approximately 30%\nAs an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.","description_format":"text","description_chars":5513,"description_truncated":false,"requirements":{"experience_years_min":10,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"phd","optional":false},"security_clearance":false,"languages":[]},"benefits":["Equity"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Energy Storage"],"lifecycle":[{"event":"open","at":"2026-10-03T22:27:31Z"}],"visa":[],"liveness":{"score":85,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.848,"p_room":1,"age_days":7,"expected_fill_days":40,"reasons":["conf:0","win:early"],"computed_at":"2026-10-09T06:01:00Z"},"pay":{"stated_usd_annual":160000,"is_top_pay":true},"html_url":"https://alion.io/job/polypore-sr-manager-cmc-analytical-development","json_url":"https://alion.io/job/polypore-sr-manager-cmc-analytical-development.json","meta":{"generated_at":"2026-10-10T02:07:09Z","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","counted_by":"address","units_charged":1,"used_today":3761,"day_limit":5000,"remaining_today":1239,"minute_limit":60,"resets_at":"2026-10-11T00:00:00Z"}},"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":2254853},"rest":"https://alion.io/mcp/rest/get_company?id=2254853"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fpolypore-sr-manager-cmc-analytical-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%2Fpolypore-sr-manager-cmc-analytical-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%2Fpolypore-sr-manager-cmc-analytical-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/polypore-sr-manager-cmc-analytical-development\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fpolypore-sr-manager-cmc-analytical-development"}]}