CMC Project Manager

CMC Project ManagerKiniksa Pharmaceuticals is a commercial-stage biopharmaceutical company developing and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications. With deep expertise in immunology and inflammation, Kiniksa is advancing a growing portfolio of approved and investigational medicines, anchored by its lead product, ARCALYST®, the first and only FDA-approved therapy for recurrent pericarditis. Grounded in rigorous science and bold innovation, the company fosters a highly collaborative, patient-first culture led by accomplished life sciences leaders. At Kiniksa, talented individuals are trusted and empowered to make a real impact—shaping the future of medicine while improving the lives of patients who need it most.Reporting to the Sr. Director Tech Ops Business Operations, this individual will serve as an integral member of technical process development, analytical, manufacturing and supply chain teams at Kiniksa Pharmaceuticals. This person will partner with team and technical leads to manage complex CMC activities for one or more products, analyze product development scenarios, and play a key role in budget forecasting and management. This cross-functional position requires a solid understanding of the functional operations involved in Chemistry, Manufacturing, and Controls for biologics including (but not limited to) drug substance, drug product, analytical development and quality control. Direct experience managing technical transfers is a must. The ideal candidate will also be proficient in the planning and integration of combination product, supply chain, and regulatory activities.The CMC project manager will support technical teams and manage associated projects both in-house and at external development, testing, and manufacturing organizations. Ability to work some flexible hours is a must to manage activities and interactions with global partners.This role is based in our Lexington, MA office and requires employees to be onsite five days per week.Responsibilities (including, but not limited to):Support development and management integrated project plans for one or more productsPartner with technical project leaders to coordinate project meetings, communicate progress, and prioritize activitiesManage relationships with CDMOs to enable successful outcomes and on-time/on-budget development and manufacturing activitiesPrepare clear communication documents such as meeting minutes and registers capturing decisions, actions, risks, and assumptionsAssist with routine project health assessments including maintenance of risk registry, risk identification, mitigation development, and communication/escalation to key stakeholders as appropriateSupport project team preparation for governance meetingsOversee day to day contract activities with external vendors from scope development through progress tracking, accruals, and invoicingParticipate in scenario development and strategic planningSupport budget development and long-range forecastingStandout Skills for Impact:Prior experience working with CDMOs and managing external tech transfersQualifications and Experience:Requires a Bachelor's Degree in Science, Engineering or a related field with at least 2-5 years relevant biopharmaceutical industry experienceA minimum of 1 year of project management experience as either a designated project manager or PM responsibilities as part of a technical roleStrong written/oral communication skillsWorking knowledge of large (preferred) and/or small molecule process development and GMP manufacturingPrior experience working with CDMOs and managing external tech transfersWorking knowledge of project management tools and techniquesInformed on current biopharmaceutical industry requirements, news and trendsIndependent, motivated, team member with experience in a matrix environmentStrong business acumenAbility to foster effective relationships and collaboration, motivate others, influence without authorityAbility to accommodate flexible working hours to support business relationships in different time zonesSome domestic and international travel may be requiredCompensation decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks.Pay Range$145,000 - $150,000 USDKiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category. We 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.Kiniksa does not accept unsolicited resumes from staffing agencies or search firms. Any resumes submitted without a signed agreement will be considered property of Kiniksa, and no fees will be paid.