{"id":866661,"url":"https://alion.io/job/treelinebiosciences-director-analytical-development-quality-control","title":"Director, Analytical Development & Quality Control","company":{"id":720772,"name":"Treeline","domain":"treeline.bio","url":"https://alion.io/company/treeline-4","size_band":"201-500","is_staffing_agency":false,"is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"head","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Watertown, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":193877,"max":232875,"currency":"USD","period":"year","gross":null,"usd_annual":232875},"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GCP","optional":true},{"name":"Telegram","optional":true}],"status":"live","first_seen_at":"2026-08-27T14:04:13Z","employer_posted_date":"2026-09-11","last_verified_at":"2026-09-24T16:53:46Z","board_verified":true,"closed_at":null,"days_open":28,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":28},"description":"Position Summary\nThe Director of Analytical Development & Quality Control will provide strategic and operational leadership for analytical development, characterization, method validation, transfer, and quality control activities supporting a growing pipeline of small molecule Oral Solid Dose (OSD) and parenteral Drug Product programs. The incumbent will have deep experience in analytical activities required to support early-stage to late-stage oral solid dose and parenteral drug products. Additional experience in antibody/ADC manufacturing-focused analytical activities is desirable. This individual will be responsible for operating in a 100% outsourced environment to establish and manage phase-appropriate analytical strategies from preclinical through commercialization, overseeing external analytical operations, and ensuring compliance with global regulatory expectations and GMP requirements for assigned programs.\nAs a key member of the Technical Operations team, the Director will collaborate cross-functionally with Medicinal Chemistry, Toxicology, Clinical Pharmacology, Drug Substance, Drug Product, ADC production, Regulatory Affairs, Quality Assurance, and external CDMOs/CRO/consultants to advance programs efficiently through development milestones while building scalable analytical and quality control capabilities for a rapidly growing organization.\nKey Responsibilities\nAnalytical Development Leadership\nLead, develop and execute phase-appropriate analytical method development and testing strategies and activities supporting Drug Product development, with an emphasis on small-molecule OSD and large-molecule parenteral Drug Product analytical method development and testing for assigned programs, including:\nPhase-appropriate small molecule oral solid dose drug product method development and testing (tablets, capsules, gelcaps)\nPhase-appropriate method development supporting antibody manufacture, ADC conjugation, and parenteral drug product manufacture.\nProvide technical oversight for development, qualification, validation, and lifecycle management of analytical methods.\nEnsure analytical methods support process development, formulation development, manufacturing, release testing, and regulatory submissions.\nDepending on experience, incumbent may serve as the company's analytical subject matter expert for ADC development.\nSupport characterization of monoclonal antibodies, cytotoxic payloads, linkers, conjugates, and related impurities.\nGuide implementation and interpretation of advanced analytical techniques such as: HPLC, UPLC, LC-MS, HRMS, SEC, CE-SDS, icIEF, HIC, ELISA, and bioassays.\nCollaborate with external CDMOs and internal process development teams to define CQAs and control strategies for ADC products.\nQuality Control Oversight\nEstablish and lead QC strategies across clinical manufacturing operations for assigned programs.\nOversee external GMP testing activities including raw materials, IPCs, release testing and stability programs.\nEnsure timely release and disposition support for clinical materials.\nManage investigations involving OOS, OOT, deviations, and laboratory events.\nRegulatory and Quality Support\nAuthor and review analytical sections of regulatory submissions including: INDs, IMPDs, BLAs, NDAs, and CTAs for assigned programs.\nEnsure analytical approaches align with ICH, FDA, EMA, and other global regulatory expectations.\nSupport establishment of specifications and analytical control strategies throughout the product lifecycle.\nMay participate in regulatory agency interactions and inspections.\nEnsure compliance with cGMP, GLP, GCP, and data integrity requirements.\nPartner closely with Quality Assurance to maintain inspection readiness.\nSupport audits of contract testing laboratories and manufacturing partners.\nExternal Partner Management\nManage relationships with contract laboratories and CDMOs.\nOversee method transfers, validation activities, and technical governance of external laboratories.\nEstablish performance metrics and ensure delivery against development and manufacturing timelines.\nEvaluate/implement new technologies/outsourced capabilities as needed.\nRequired Qualifications\nEducation\nPh.D./MS in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, Biotechnology, Chemical Engineering, or related scientific discipline preferred.\nExperience\n12+ years (Ph.D.)15+ years (MS) of progressive pharmaceutical or biotechnology analytical development experience.\n Demonstrated deep experience in analytical development activities supporting Drug Product development and manufacturing with emphases on oral solid dose, parenteral, and pediatric formulations.\nProven track record advancing products from early development through late-stage clinical development and/or commercialization.\nDemonstrated success working with CDMOs and global development partners.\nAdditional experience in development and implementation of analytical methods to support antibody/ADC manufacturing is preferred.\nTechnical Expertise\nStrong working knowledge of:\nAnalytical method development and validation\nStability programs and specification setting\nQuality control laboratory operations\nGMP analytical testing\nOral solid dose characterization and phase-appropriate method development, including discriminatory dissolution method development\nADC analytical characterization\nExperience with Biologics testing methodologies preferred\nICH Q1, Q2, Q3, Q6, Q7, Q8, Q9, Q10, and Q14 guidance\nRegulatory submissions and health authority interactions\nLeadership Competencies\nStrategic thinker with strong business and scientific acumen.\nExcellent project management and organizational skills.\nStrong communication and influence skills across scientific, quality, regulatory, and program teams\nAbility to travel (20%) to CDMO domestic and international sites.\nFluency with standard computer software packages (MS Word, Excel, PowerPoint, and Project), iStability, and JMP (or similar statistical tools).\nHigh level of personal integrity, commitment to excellence and to our patients.\nExperience in developing and commercializing drugs for oncology is preferred.\nThis position is classified as exempt. The anticipated annual base salary range for candidates who will work in Watertown is $193,877 to $232,875. The final base salary offered to the successful candidate will be dependent upon several factors that may include but are not limited to the type and length of experience within the job, and other factors. Treeline Biosciences is a multi-state employer, and this salary range may not reflect positions that work in other cities or states.\n\nRecruitment fraud statement\nPlease be aware of recruitment fraud and related job scams, where scammers present themselves as recruiters but are seeking to steal money or personal information. Keep the following in mind to protect yourself:\nTreeline Biosciences will never ask for money from you as part of our recruitment process. Do not provide bank details or pay somebody for the promise of a job at Treeline.\nWe do not conduct interviews through RingCentral, Skype or Telegram.\nOur job openings are first posted to treeline.bio/careers. If you locate a listing for a Treeline job on another site, please ensure it is also posted on our careers website.\nYou can find more information about job scams at consumer.ftc.gov/articles/job-scams.\n To report job scams, head to ReportFraud.ftc.gov.\nNotice to Search Firms/Third-Party Recruitment Agencies (Recruiters)\nThe Human Resources team manages the recruitment and employment process for Treeline Biosciences. To protect the interests of all parties involved, Treeline Biosciences will only accept resumes from a recruiter if an executed search agreement directed to the particular position or positions is in place at the start of the recruitment effort. Unsolicited resumes sent to Treeline Biosciences from recruiters do not constitute any type of relationship between the recruiter and Treeline Biosciences and do not obligate Treeline Biosciences in any way to pay fees should we hire from those resumes. Recruiters are requested not to contact or present candidates directly to our hiring manager or employees.","description_format":"text","description_chars":8191,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"phd","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["CRO & CDMO Services"],"lifecycle":[{"event":"open","at":"2026-09-13T13:56:27Z"}],"liveness":{"score":77,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":0.9,"age_days":27,"expected_fill_days":43,"reasons":["conf:2","win:mid"],"computed_at":"2026-09-24T05:45:00Z"},"pay":{"stated_usd_annual":232875,"is_top_pay":true},"html_url":"https://alion.io/job/treelinebiosciences-director-analytical-development-quality-control","json_url":"https://alion.io/job/treelinebiosciences-director-analytical-development-quality-control.json","meta":{"generated_at":"2026-09-24T19:51:13Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers"}}