Director, QC Analytical

DescriptionAt Viridian, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team’s expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic candidates for well-validated targets.Reporting to the Executive Director of Quality Control, the Director of QC Analytical will lead teams responsible for critical QC Analytical functions, including Method performance, method transfer, specification, Reference standard/critical reagent management, supplier oversight management of key quality systems for respective areas. This role will partner closely with internal stakeholders and external organizations to develop, implement, and continually improve operational strategies while maintaining full compliance with applicable quality and regulatory requirements. This role is based in our Waltham, MA headquarters. Our office-based employees are required to work in the office three (3) days a week.Responsibilities (including, but not limited to):Provide strategic leadership to the QC Analytical team, including oversight of external partners to support all stages of program developmentCollaborate closely with CMC functions, including Analytical Development and Process Development, to ensure aligned QC supportLead method lifecycle management for QC owned methods including transfers, validations, performance monitoring, and improvementsProvide strategic oversight for late phase reference standard implementation and ongoing lifecycle managementProvide oversight of specifications throughout product lifecycleAnalyze and present data, present to both internal and external stakeholdersEnsure QC deliverables are met and provide leadership/professional development for teamOversee external partners (e.g., CMOs, CTLs) to ensure adherence to quality and regulatory expectationsSupport regulatory submissions by authoring and reviewing relevant CMC sectionsPrepare QC personnel for inspection readiness, support vendor audits, and serve as the QC subject matter expert during inspectionsOversee quality records within assigned areas, including robust management of OOS/OOT investigations and related deliverablesRequirementsQualifications:Require a BS, MS, or PhD in a life science discipline with a 12+ years of relevant industry experienceStrong background in analytical methods and data analysis, including compendial methodsDemonstrated leadership experience in QC operations and oversight of external CMOs/CTLsDeep knowledge of cGMP, ICH, FDA, and EU regulations and guidanceProven hands-on experience with analytical methods including but not limited to SEC, icIEF, CE-SDS, Peptide mapping, Potency and compendial methods as well as functional device testingStrong people leadership skills, with experience coaching, developing, and managing staff at various levelsComfortable in an adaptable small company environment with minimal direction and able to adjust workload based upon changing prioritiesStrong commitment to ethical standardsProficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)Ability to travel up to 5%The salary range for this position is commensurate with experienceViridian offers a comprehensive benefits package including:· Competitive pay and stock options for all employees· Medical, dental, and vision insurance· 100% Paid Parental Leave · Short- and long-term disability coverage· Life, Travel and AD&D· 401(k) Company Match with immediate company vest· Employee Stock Purchase plan· Generous vacation plan and paid company holiday shutdowns· Various fertility, mental, financial, and proactive physical health programsViridian Therapeutics, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination, harassment, or retaliation of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by Federal, State, and Local laws. Viridian will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.Viridian Therapeutics, Inc participates in E-Verify, the federal program for electronic verification of employment eligibility.Employee Type: FT Exempt