Director, CMC and Life Cycle Management (LCM) Lead

Title: Director, CMC and Life Cycle Management (LCM) LeadReports to: Vice President, Technical OperationsLocation: Redwood City, CAClassification: ExemptOverview:The Director of CMC and Life Cycle Management (LCM) Lead is responsible for creating and driving programs from development to commercial launch in collaboration with CMC leadership and cross functional teams and for leading Life Cycle Management (LCM) activities post launch.Responsibilities:Lead and facilitate CMC and LCM cross-functional teams, including scheduling, developing agendas, writing and distributing meeting minutes, and tracking decisions and action itemsPartner with cross-functional leadership to establish comprehensive, functionally integrated, end-to-end CMC timelines that are aligned with overall program timelines and strategyIn collaboration with internal project teams and external vendorsImplement project plansIdentify and manage critical path activities and their interdependenciesIdentify and proactively mitigate roadblocksIdentify and communicate risks and key mitigationsCapture and communicate progress to senior leadership; escalate potential delays with proposed solutionsDevelop and manage program budgets, including purchase orders and SOWsResponsible for all project team documentation, including agendas, minutes, actions, decisions, timelines, scorecards, goals, and dashboardsFacilitate internal project team meetings and weekly working team calls with vendorsPresent project updates, issues, path forward options, and recommendations to program team and functional Senior Management in timely fashionCollaborate with personnel across Coherus to ensure alignment around key business objectivesEnsure that projects adhere to agreed-upon scope, timelines, resources, and budget; resolve or communicate departuresQualifications:B.S. or B.E. in chemical engineering, bioengineering or related field. A postgraduate degree (e.g. MS, PhD) is a plus8+ years of Pharmaceutical/ Biotech industry experience in technical operationsStrong technical understanding of CMC development from early to late stage, validation, and commercialization requirementsWorking knowledge of GMP regulations, PPQ expectations, and regulatory filing timelines (IND, BLA/NDA, supplements)Experience in managing late-stage commercial products is a plusKnowledge of applicable Quality and Regulatory guidelines5+ years of Project Management experience and knowledge of project management methodologies, concepts and techniques is required; Project Management certificate is a plusPrior experience working in a fast-paced, entrepreneurial, development-stage companyPrior experience managing third-party relationshipsAbility to manage complex, cross-functional projects with internal and external stakeholdersExcellent written, communication and organizational skillsExpertise using Project Management software to build timelines and manage resources, risks, and costsRapidly integrate new information into existing plansWork well under tight deadlines, with the ability to prioritize workload against deadlines and corporate objectivesWork well in cross-functional teams and be able to communicate effectively with external partners, peers, and senior managementStrong negotiating and interpersonal skills, and the ability to clearly present recommendationsPossess excellent decision-making, leadership, interpersonal, verbal and written communication skillsThe Base Salary Range for this position is $190,000 to $240,000. Coherus considers various factors, including professional background and work experience, when determining base pay. These considerations mean actual compensation will vary.Coherus provides equal employment opportunities to all employees and applicants for employment and prohibits unlawful discrimination and harassment 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 or local laws. We also prohibit discrimination based on the perception that anyone has any of these characteristics or is associated with a person who has or is perceived as having any of these characteristics.