{"id":3002492,"url":"https://alion.io/job/pepgen-associate-director-analytical-development","title":"Associate Director, Analytical Development","company":{"id":3862562,"name":"PepGen","domain":"pepgen.com","url":"https://alion.io/company/pepgen","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"JazzHR","truth_index":null},"role":"Biotech","role_family":"Biotech","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":[],"countries":[],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":170000,"max":220000,"currency":"USD","period":"year","gross":null,"usd_annual":220000},"salary_estimate":null,"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Chromatography","optional":false},{"name":"GMP","optional":false},{"name":"HPLC","optional":false},{"name":"Mass Spectrometry","optional":false}],"status":"live","first_seen_at":"2026-10-21T12:40:40Z","employer_posted_date":"2026-10-21","last_verified_at":"2026-10-24T20:49:11Z","board_verified":true,"closed_at":null,"days_open":3,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":3},"description":"Reporting to the Executive Director, Analytical Development & QC, the Associate Director, Analytical Development will be managing the internal lab, supporting the analytical development needs of PepGen’s pipeline. The successful candidate will have great opportunities to manage a lab with state-of art instruments, like UHPLC-TOF, UHPLC-MS/MS, etc. for studying various potential drug candidates to ultimately create transformational therapies for patients with neuromuscular disease. The candidate will lead internal method development, extended characterization and analytical support for drug discovery and development in-house and at contract testing labs. The successful candidate will manage their team to work very closely within AD/QC, and with CMC and discovery teams to develop and qualify chromatographic and LC-MS based methods for characterization of various chemical entities like peptides, oligos and PepGen´s proprietary enhanced delivery oligonucleotides (EDOs), which is essential to the quality of therapies for patients. In addition, this candidate will play a critical role in building a strong analytical development/QC team at PepGen.\nResponsibilities\nManage the internal analytical development lab by continuously assessing new technologies and implementing them to support the needs within AD/QC and from multiple cross-function teams.\nLead the development of analytical methods for the purity/impurity analysis and impurity characterization of small molecules, peptides, Phosphonodiamidite Morpholino Oligomers (PMOs), and Peptide Conjugated Phosphorodiamidate Morpholino Oligomers (PPMOs).\nProvide analytical support to internal discovery and development activities, including sample management, sample analysis/characterization, and issuance of certificate of testing (COT), etc.\nPerform/guide routine maintenance of analytical equipment, HPLC systems, balance, pH meters, etc.\nContribute to analytical method development, validation and transfer (mainly UHPLC-UV and LC-MS methods) at external labs and provide necessary technical support for method troubleshooting at CMOs and CTLs.\nReview method development and validation protocols and reports generated by CTLs and CMOs\nReview drug substance and drug product release and stability testing data generated by CTLs and CMOs as needed. \nWrite analytical protocol and report for in-house analytical activities and prepare analytical source documents to summarize analytical activities for regulatory filing.\nLead extended characterization activities including, but not limited to impurity identification, analytical comparability, method bridging, high-order structure and reference standard characterization.\nLead analytical comparability strategy and execution.\nLead critical quality attribute (CQA) assessment for DS and DP.\nCommunicate and manage external contract labs for characterization activities. \nCoach, mentor and manage direct reports for daily work and provide support to their career development.\nWork closely within AD/QC and with cross-function teams to initiate and streamline AD related processes.\nContribute to budget planning by providing key information on extended characterization activities\nAuthor relevant IND/IMPD sections, briefing books to support regulatory filings\nFoster a culture of collaboration, innovation, discovery, and cutting-edge research culture focused on scientific excellence, open communication, and continual improvement\n Requirements:Ph.D. in Chemistry or related area and 5+ years’ or Masters degree and 8+ years’ experience leading teams and projects in analytical development\nExperience with peptides, oligonucleotides, or/and peptide-oligo conjugate\nExperience leading CQA assessment and NDA-enabling characterization\nExperience leading analytical comparability and authoring regulatory filing sections\nDemonstrate prototypical leadership skills, planning, and organizational capabilities\nEffectively implement work plans cross-functionally\nExperience in the development, transfer, and validation of chromatographic methods (HPLC, GC, LC-MS, etc.).\nFamiliarity with USP, EP, and ICH guidelines for analytical method development and validation.\nGood working knowledge of current Good Manufacturing Practices (cGMPs)\nExperience managing/working with quality control release/stability testing at a CTL or CMO is a plus.\nAbility to effectively prioritize and deliver on tight timelines and work in a fast paced/dynamic environment.\n CompensationThe estimate full-time salary range for this role is between $170,000 to $220,000. The final compensation package offered to a successful candidate will reflect a number of factors including but not limited to prior experience, relevant skills, education, qualifications and certifications, business needs, internal equity, and market data.\nPepGen provides eligible employees a comprehensive and competitive total compensation package including but not limited to a discretionary annual bonus, equity, health insurance (including medical, dental, and vision), life and disability insurance, paid time off with paid holidays, paid parental leave, a 401(k) plan, cell phone reimbursement, student loan repayment or 529 contributions, and a lifestyle spending account.\nAbout PepGen\nPepGen is a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases. PepGen’s Enhanced Delivery Oligonucleotide (EDO) platform is founded on over a decade of research and development and leverages cell-penetrating peptides to improve the uptake and activity of conjugated oligonucleotide therapeutics. Using these EDO peptides, we are generating a pipeline of oligonucleotide therapeutic candidates designed to target the root cause of serious diseases.\nFor more information, please visit PepGen.com. Follow PepGen on LinkedIn and X.\nEEO Statement\nPepGen is an Equal Opportunity Employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status.\nRecruitment & Staffing Agencies\nPepGen does not accept unsolicited agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited. Thank you.\nE-Verify\nPepGen is an E-Verify Employer. 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