Associate Director, Analytical Development - Biologics

MISSIONMirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we’re looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously.POSITION SUMMARYWe are looking for an Associate Director of Analytical Development – Biologics who is organized, self-motivated, collaborative, detail-oriented, has a strong analytical background and knowledge base. The person filling this role will partner with the Executive Director of Analytical Development/QC – Biologics to execute and support method development and validation, technology transfer, method lifecycle management, ensuring that methods are scientifically sound, robust, fit for purpose and compliant with applicable regulatory requirements. This role requires a pragmatic hands-on scientist who exercises scientific judgement and proactively identifies and resolves technical challenges to meet program milestones. This position is located in Foster City.JOB FUNCTIONS/RESPONSIBILITIESServe as a key member of cross-functional CMC teams comprising Quality, Manufacturing, and Regulatory representativesLead and support method transfer activities between external sending and receiving laboratoriesReview analytical method validation and transfer protocols and reportsProvide technical support to receiving laboratories on analytical procedures and instrumentation as required and to ensure successful transferEnsure transferred methods meet predefined acceptance criteria and are suitable for routine GMP testingSupport risk assessments, gap assessments, and method comparability evaluations in support of method transferSupport analytical method related and product trending activitiesOversee reference standard and critical reagent qualification and inventory managementRecord and report analytical results accurately in worksheets, logbooks, LIMS, or electronic systemsReview analytical data for accuracy, completeness, and compliance with GMP and data integrity requirementsRecord and report analytical results accurately in LIMS, or electronic systemsWork with QC and QA to support investigations related to OOS, OOT and OOE, deviations and laboratory incidentsFollow company SOPs, pharmacopoeia methods, and regulatory guidelines, e.g. USP, EP, ICH, and FDA/EMA requirementsQUALIFICATIONSEducation /Experience:BS/MS in Biochemistry, Chemistry, or a Biological Science with 8+ years of industry experience in biologics pharmaceutical manufacturing and testingHands-on experience with analytical instruments, especially CE, HPLC, UV, and LC-MS for biological compoundsKnowledge of GXPKNOWLEDGE, SKILLS, AND ABILITIESStrong interpersonal skills and ability to collaborate across functionsAbility to respond effectively to changing priorities, evolving program needs, and unexpected technical challengesExperience with technology transfer to multiple locations and countries for clinical and late phase product testingAbility to investigate and troubleshoot analytical issuesAbility to work under deadlines and manage multiple projectsExperience with stability testing and analytical method transfer/validation.Strong attention to detail and accuracyExcellent analytical skills and data management skillsGood documentation and report-writing skills.Excellent communication skills for both written and verbal presentationsTrack record in authoring and reviewing of regulatory documentation (e.g. INDs, IMPD, MAAs, BLAs)The salary range for this position is $190,000 to $210,000USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee’s geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided.#LI-HYBRIDMirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran’s status or any other classification protected by applicable State/Federal/Local laws.Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.