<p>Kiniksa Pharmaceuticals is a commercial stage, publicly traded biopharmaceutical company with the mission to help patients suffering from debilitating diseases with significant unmet medical need. Kiniksa's portfolio of assets, includes ARCALYST (rilonacept), which was approved by the FDA in 2021, as well as other clinical assets that are based on strong biologic rationale or validated mechanisms. The company is led by an experienced management team with a history of success and is well-capitalized with a top tier institutional shareholder base.</p> <p>Reporting to the Exec. Director of Drug Substance Process Development and Manufacture, the associate director, Downstream Process Development and Manufacture will be responsible for managing and supporting the downstream development and manufacturing activities of late-stage programs, including process development, tech transfer, GMP manufacturing, on floor support, process characterization, process validation, Life cycle management, and BLA-enabling studies. It extends further to the preparation of CMC content for regulatory submissions and correspondences.</p> <p>The incumbent will oversee the planning and execution of outsourced CMC activities, and work proactively with service providers to define project scope and ensure successful delivery with regard to technical quality, timeline and budget. S/he will contribute to the identification and selection of CROs and CDMOs and building/maintaining strong working relationships with their respective technical staff and management. S/he will also manage the tech transfer activities between various manufaturinfg sites and work with internal lab to design and coordinate development studies.</p> <p>This role is based in our Lexington, MA office.</p> <p>Job Responsibilities (including but not limited to):</p> <ul> <li>Manage and support downstream development and manufacturing activities of late stage programs, including process development, tech transfer, GMP manufacturing, process characterization, process validation, life cycle management, and BLA-enabling studies </li><li>Manage and support tech transfer activities between various manufacturing sites and provide on floor support during GMP manufacturing operations </li><li>Collaborate with internal lab to design and execute development studies </li><li>Provide technical input for the development and scale up of robust downstream processes </li><li>Author and review CMC documentation for regulatory filings, as needed </li><li>Establish and maintain an understanding of current trends and emerging downstream process technologies to ensure that team is at the forefront of biologics development </li><li>Apply innovative technical ability and knowledge to critically analyze experimental data and results </li><li>Set clearly defined goals/objectives to ensure delivery of high-quality results </li><li>Provide clear communication to functional line management and cross-functional teams regarding progress against technical objectives/milestones </li><li>Ensure well-organized, clear and complete records of all activities across areas of responsibility </li><li>Approximately 5-10% of domestic and/or international travel </li></ul> <p>Qualifications and Experience</p> <ul> <li>Ph.D. in chemistry, biochemistry, (bio)chemical engineering (or other relevant physical or life sciences discipline) with 5+ years of biologics drug development experience in pharma/biotech, or MS with equivalent education with 7+ years of biologics drug development experience in pharma/biotech </li><li>Experience in the areas of downstream process development and process characterization based on quality by design (QbD) principles </li><li>Expert knowledge of protein purification unit operations and process technologies (e.g., centrifugation, filtration, chromatography, etc.) and experience in advancing biologics processes through clinical development to successful regulatory approval/licensing. </li><li>Knowledge of and experience with production of recombinant proteins using mammalian cell lines. </li><li>Experience and knowledge in process validation preferred </li><li>Excellent communication and interpersonal skills fostering team spirit </li><li>Strong technical/analytical skills to identify and solve problems </li><li>Self-motivated, assertive, and self-confident with the ability to act with urgency and passion </li><li>Proven ability to manage projects and work with a high level of integrity, accuracy, and attention to detail </li><li>Strong organizational skills in order to maintain a high level of productivity, innovation, and priority-setting in order to complete assignments on time and on budget </li><li>Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company </li><li>Ability to make thoughtful, integrated, timely and meaningful decisions and take corresponding actions </li><li>Willingness to work collaboratively by incorporating diverse perspectives and appropriately managing relationships in order to strength decision-making </li><li>Resourceful, creative, enthusiastic, and results-oriented </li><li>Salary is commensurate with experience. </li><li>Kiniksa Benefits Summary - USA </li></ul> <p>The expected salary range for Associate Director, Downstream Process Development and Manufacture</p> <p>is $190k-205K annually. Compensation decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks.</p> <p>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.</p>