--- title: 'CMC Project Manager at Kiniksa Pharmaceuticals' canonical: 'https://feeny.ai/job/cmc-project-manager-kiniksa-pharmaceuticals-lexington-vwrkbs252sf5' type: 'job' last_seen: '2026-10-12' --- # CMC Project Manager at Kiniksa Pharmaceuticals - **Company:** Kiniksa Pharmaceuticals - **Location:** Lexington, MA - **Compensation:** $145k–$150k - **Posted:** 2026-09-22 - **Last confirmed live:** 2026-10-12 - **Apply:** https://job-boards.greenhouse.io/kiniksapharmaceuticals/jobs/4414920009 ## Job description Kiniksa 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 products - Partner with technical project leaders to coordinate project meetings, communicate progress, and prioritize activities - Manage relationships with CDMOs to enable successful outcomes and on-time/on-budget development and manufacturing activities - Prepare clear communication documents such as meeting minutes and registers capturing decisions, actions, risks, and assumptions - Assist with routine project health assessments including maintenance of risk registry, risk identification, mitigation development, and communication/escalation to key stakeholders as appropriate - Support project team preparation for governance meetings - Oversee day to day contract activities with external vendors from scope development through progress tracking, accruals, and invoicing - Participate in scenario development and strategic planning - Support budget development and long-range forecasting Standout Skills for Impact: - Prior experience working with CDMOs and managing external tech transfers Qualifications and Experience: - Requires a Bachelor's Degree in Science, Engineering or a related field with at least 2-5 years relevant biopharmaceutical industry experience - A minimum of 1 year of project management experience as either a designated project manager or PM responsibilities as part of a technical role - Strong written/oral communication skills - Working knowledge of large (preferred) and/or small molecule process development and GMP manufacturing - Prior experience working with CDMOs and managing external tech transfers - Working knowledge of project management tools and techniques - Informed on current biopharmaceutical industry requirements, news and trends - Independent, motivated, team member with experience in a matrix environment - Strong business acumen - Ability to foster effective relationships and collaboration, motivate others, influence without authority - Ability to accommodate flexible working hours to support business relationships in different time zones - Some domestic and international travel may be required Compensation 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 USD Kiniksa 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. ## About Kiniksa Pharmaceuticals ## Company Overview - **One-liner**: Kiniksa Pharmaceuticals is a global biopharmaceutical company focused on discovering, developing, and commercializing novel, transformative therapies for patients with significant unmet medical needs, with a primary focus on cardiovascular diseases and immune modulation. - **Entity Type**: Public (NASDAQ: KNSA) - **Headquarters**: Lexington, Massachusetts, USA (with additional offices in La Jolla, CA; Zug, Switzerland; and London, UK) - **Founded**: 2015 - **Founders**: Sanj K. Patel (CEO & Chairman) ## Core Business - **Primary industry/industries**: Biopharmaceuticals, Biotechnology - **Target customers**: Patients, healthcare providers, and payers (B2B/B2C model in specialty pharma) - **Mission or purpose statement**: Dedicated to placing patients first and driving innovation in novel, life-changing therapies to address unmet medical need. The company operates under the belief that "every second makes a difference for patients living with debilitating diseases." ## Products & Services - **ARCALYST® (rilonacept)**: An FDA-approved treatment for recurrent pericarditis — the first and only FDA-approved therapy for this indication. It is an interleukin-1 alpha and beta cytokine trap. - **Mavrilimumab**: A clinical-stage anti-GM-CSF receptor alpha monoclonal antibody. A Phase 2 trial in non-mechanically ventilated severe COVID-19 patients yielded positive results. Kiniksa and Huadong Medicine have a collaboration to develop and commercialize it in the Asia Pacific region (excluding Japan). - **Vixarelimab**: A clinical-stage asset acquired via a global license agreement with Roche and Genentech. It has received FDA Breakthrough Therapy designation for pruritus associated with prurigo nodularis. - **KPL-404**: A clinical-stage asset for which Kiniksa has initiated a first-in-human study with an antigen challenge (TDAR). ## Market Standing - **Valuation/Market Cap**: Approximately $1.7 billion (as of mid-2026) - **Key Metric**: Annual Revenue of $677.6 million (as of mid-2026); Total Funding raised ~$80M in Series A and $170.7M in gross IPO proceeds (2018) - **Notable Investors/Partners**: Huadong Medicine (Asia Pacific collaboration), Roche, Genentech - **Growth Signals**: FDA approvals and breakthrough designations, expanding global footprint (UK, Switzerland, Netherlands offices), headcount of 310 employees and growing, active job postings (36 as of mid-2026) ## Competitive Advantages - **Approved Commercial Product**: ARCALYST® is the first and only FDA-approved therapy for recurrent pericarditis, creating a strong market foothold and revenue stream. - **Strong Pipeline**: Combination of FDA-approved therapy and clinical-stage assets with strong biologic rationale and validated pathways. - **Strategic Collaborations**: Partnerships with Roche/Genentech and Huadong Medicine provide access to global markets and cutting-edge science. - **Leadership**: Led by a team of distinguished life sciences leaders with over 30 years of combined industry experience. ## Strategic Focus - **Current priorities**: Commercializing ARCALYST® and expanding its indications; advancing the pipeline of clinical-stage assets (mavrilimumab, vixarelimab, KPL-404); expanding global presence (especially in Asia Pacific and Europe); pursuing further strategic acquisitions and collaborations. - **Patient-centric innovation**: Focus on immune modulation targeting unmet needs and underserved conditions. ## Why Work Here - **Culture**: Fosters a culture of passion, innovation, and rapid execution. Employees are described as "highly skilled, driven people advancing their careers—and making a difference in patients' lives." - **Commitment to employees**: Kiniksa is intentional about cultivating a highly skilled and passionate team determined to deliver on its promise to patients. - **Work environment**: Global company with offices in the US (Lexington, MA; La Jolla, CA), Switzerland (Zug), and the UK (London). The company offers a collaborative, science-driven environment. - **Diversity, Equity, and Inclusion**: Committed to creating a culture of equality that celebrates diversity and fosters innovation; an Equal Opportunity Employer. - **Perks & Benefits (US)**: - **Healthcare & Well-being**: Robust PPO medical insurance (Blue Cross Blue Shield) with HRA to cover deductible; dental (including orthodontia); vision; flexible spending accounts; fertility benefits and parental leave (up to 10 weeks at 100% pay, plus 6-8 weeks disability for birth parents); behavioral health support via EAP; and mental health programs. - **Financial & Protection**: 401k with traditional and Roth options through Fidelity, with immediate company match; Employee Stock Purchase Plan (15% discount); employer-paid life and AD&D insurance; short- and long-term disability coverage; voluntary additional life insurance. - **Work-Life Balance**: Paid sick and vacation time; company-paid holidays; company-sponsored events and volunteer opportunities. - **Other**: Subsidized lunches; employee referral program; starting coverage on the first day of employment. ## Sources 1. [Kiniksa Pharmaceuticals - About Us](https://www.kiniksa.com/about) 2. [Kiniksa Pharmaceuticals - Join Us](https://www.kiniksa.com/join-us) 3. [Kiniksa Pharmaceuticals - Leadership](https://www.kiniksa.com/leadership) 4. [Kiniksa Pharmaceuticals - LinkedIn Company Page](https://www.linkedin.com/company/kiniksa-pharmaceuticals) 5. [Kiniksa Pharmaceuticals - Main Site](https://www.kiniksa.com/) ## Other roles at Kiniksa Pharmaceuticals - [Assoc. Director, Quality Management Systems](https://feeny.ai/job/assoc-director-quality-management-systems-kiniksa-pharmaceuticals-lexington-sgeh0ans7am4) — Lexington, MA - [Assoc. Director, Clinical Quality Assurance](https://feeny.ai/job/assoc-director-clinical-quality-assurance-kiniksa-pharmaceuticals-lexington-0qmsbr1k9dfj) — Lexington, MA - [Clinical Sales Specialist-Phoenix](https://feeny.ai/job/clinical-sales-specialist-phoenix-kiniksa-pharmaceuticals-phoenix-w7rensy8mm79) — Phoenix, AZ - [Clinical Sales Specialist-Tucson](https://feeny.ai/job/clinical-sales-specialist-tucson-kiniksa-pharmaceuticals-tucson-zgq19bbc9pr2) — Tucson, AZ - [Clinical Sales Specialist- San Jose](https://feeny.ai/job/clinical-sales-specialist-san-jose-kiniksa-pharmaceuticals-field-tkgmyvb7w4hz) — Field - [Clinical Sales Specialist- Southern Colorado](https://feeny.ai/job/clinical-sales-specialist-southern-colorado-kiniksa-pharmaceuticals-field-0av43m0vtzxt) — Field - [Clinical Sales Specialist- Kentucky](https://feeny.ai/job/clinical-sales-specialist-kentucky-kiniksa-pharmaceuticals-field-38zz57hg9k0p) — Field - [Director, Medical Writing](https://feeny.ai/job/director-medical-writing-kiniksa-pharmaceuticals-lexington-87fpdgh3y7c4) — Lexington, MA - [Manager, Medical Review & Communications, Global Medical Affairs](https://feeny.ai/job/manager-medical-review-communications-global-medical-affairs-kiniksa-abcmwczpw4am) — Lexington, MA - [Sr. Director, Clinical Supply Chain Management and Systems](https://feeny.ai/job/sr-director-clinical-supply-chain-management-and-systems-kiniksa-8szgtwx1s3fm) — Lexington, MA