Director, Formulation and Drug Product Development

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, Drug Development, the Director, Formulation and Drug Product Development will provide scientific and technical leadership for formulation and drug product development activities across Viridian's biologics pipeline. This individual will be responsible for developing and advancing formulation strategies, drug product processes, and manufacturing approaches from early development through commercialization, with a focus on monoclonal antibodies and other protein therapeutics. The role requires the ability to integrate formulation science, drug product process development, stability data, product quality understanding, and regulatory expectations into phase-appropriate development strategies.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):Lead formulation development activities for biologic products, including formulation design, excipient selection, stability strategy development, and support of clinical and commercial dosage formsDevelop scientifically sound formulation and drug product development strategies that balance product quality, manufacturability, patient needs, regulatory expectations, and program timelinesDesign, oversee, and interpret formulation development, process development, characterization, and validation studies using risk-based and data-driven approachesApply a strong understanding of protein structure, degradation pathways, formulation mechanisms, and product quality attributes to guide development decisions and address technical challengesUtilize analytical data and product characterization results to investigate stability trends, define formulation risks, support root-cause analyses, and enable informed decision-makingLead drug product process development activities, including fill-finish process development, scale-up, technology transfer, process characterization, and process validationProvide technical leadership for external CDMOs and manufacturing partners supporting formulation development, drug product development, technology transfer, and commercial readiness activitiesReview and approve technical protocols, reports, manufacturing documentation, investigations, change controls, and development plansServe as the drug product development representative on cross-functional project teams and contribute to overall CMC strategy and program executionAuthor and review drug product and formulation sections of regulatory submissions, health authority responses, and other technical documentsAssess technical risks, develop mitigation strategies, and drive resolution of formulation, manufacturing, and product quality challengesMaintain awareness of emerging technologies, industry trends, and regulatory expectations relevant to biologics formulation and drug product developmentQualifications:Ph.D. in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biochemistry, Biology, or a related scientific discipline with 8+ years of relevant industry experience strongly preferred; orM.S. with 10+ years of relevant industry experience; orB.S. with 12+ years of relevant industry experienceDemonstrated experience supporting products from early clinical development through late-stage development, process validation, and commercial readinessExperience working with external CDMOs and managing outsourced development and manufacturing activitiesDeep understanding of protein formulation science, including degradation pathways, stabilization mechanisms, excipient selection, and formulation optimizationStrong foundation in analytical characterization techniques and the ability to use analytical data to guide formulation and process development decisionsDemonstrated expertise in experimental design, data analysis, interpretation of complex datasets, and application of scientific principles to solve technical challengesExperience with high-concentration protein formulations, lyophilized products, or other challenging biologic dosage formsExperience supporting combination products, including prefilled syringes and autoinjector presentationsStrong written, verbal, and executive-level communication skills; able to operate with significant autonomy, sound judgment, and high accountability in a fast-paced matrix environmentStrong commitment to ethical standardsProficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)Ability to travel up to 15%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 LeaveShort- 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.RequirementsEmployee Type: FT Exempt