Associate Director, Analytical Development

DescriptionAt Viridian, we aim to advance new treatments for patients underserved by today’s therapies. Our team consists of talented, entrepreneurial-minded professionals dedicated to improving the lives of patients suffering from serious diseases. We strive for data-driven decisions, strategic risk-taking, and efficient use of time and funds to best position our ideas for success. We value thoughtful ideas, open communication, and transparency, and are committed to a culture that allows employees to contribute at a high level, grow their careers, and balance their personal and professional ambitions. Reporting to the Executive Director, Analytical Development, the Associate Director, Analytical Development is primarily responsible for implementation of analytical strategies for assigned programs to support Viridian’s development pipeline and contribute to sustained clinical supply through timely analytical deliverables. This is a hands-on, individual contributor role overseeing analytical workflows for multiple programs at all stages of development. This role entails significant collaboration with internal cross-functional groups as well as oversight of external CDMO/CRO partners. 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 technical guidance, and tactical direction for assigned Analytical Development projects from pre-clinical through commercialization, in alignment with broader program and functional strategyManage activities including method assessment, development, transfer and validation to support release and stability testing of drug substances and drug productsProvide detailed review and approval of analytical methods, development reports, validation protocol and reports, stability protocol, etc.Manage and provide technical guidance to support investigations, quality events and development studies at CDMO/CROsAuthor and review technical reports, technical data packages and relevant CMC sections for regulatory filings (INDs, IMPDs, NDAs, MAAs, etc.)RequirementsMaster’s degree in biochemistry, analytical chemistry or related field with 10+ years of experience or a PhD with 6+ years of experience in analytical development/sciencesDemonstration of increasing responsibility in project and people managementproject leadership and cross-functional/external partner managementExtensive hands-on experience in analytical testing of protein therapeutics is requiredExperience with broad analysis and characterization of monoclonal antibodies is preferredStrong subject matter expertise in biophysical/biochemical OR potency assays for protein therapeuticsExperience with high concentration OR combination products is preferredExperience with execution and/or oversight of analytical method development, transfer and phase-appropriate validationBroad understanding of cGMP requirements, compendial testing, and regulatory guidance with respect to development and testing of biological therapeuticsDirect experience authoring of analytical, stability and comparability sections of regulatory documents. Experience with BLA and MAA preparation is preferredExcellent interpersonal and communication skills (written and oral), including the ability to effectively present data to peers, management and external partnersProven mindset of proactive continuous improvementEfficient independent worker with ability to focus and drive for resultsStrong attention to detailAbility to work in a fast-paced environment and to handle multiple tasksStrong commitment to ethical standardsProficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)Ability to travel up to 10% The salary range for this position is commensurate with experienceViridian offers a comprehensive benefits package including:Competitive pay and stock options for all employeesMedical, dental, and vision insurance100% Paid Parental Leave Short- and long-term disability coverageLife, Travel and AD&D401(k) Company Match with immediate company vestEmployee Stock Purchase planGenerous vacation plan and paid company holiday shutdownsVarious 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