Associate Director, Downstream Process Development & Manufacture

Kiniksa Pharmaceuticals•Lexington, MA

9h•$190,000 - $205,000•Onsite

About The Position

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. 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. 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. This role is based in our Lexington, MA office.

Requirements

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
Experience in the areas of downstream process development and process characterization based on quality by design (QbD) principles
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.
Knowledge of and experience with production of recombinant proteins using mammalian cell lines.
Experience and knowledge in process validation preferred
Excellent communication and interpersonal skills fostering team spirit
Strong technical/analytical skills to identify and solve problems
Self-motivated, assertive, and self-confident with the ability to act with urgency and passion
Proven ability to manage projects and work with a high level of integrity, accuracy, and attention to detail
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
Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company
Ability to make thoughtful, integrated, timely and meaningful decisions and take corresponding actions
Willingness to work collaboratively by incorporating diverse perspectives and appropriately managing relationships in order to strength decision-making
Resourceful, creative, enthusiastic, and results-oriented

Responsibilities

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
Manage and support tech transfer activities between various manufacturing sites and provide on floor support during GMP manufacturing operations
Collaborate with internal lab to design and execute development studies
Provide technical input for the development and scale up of robust downstream processes
Author and review CMC documentation for regulatory filings, as needed
Establish and maintain an understanding of current trends and emerging downstream process technologies to ensure that team is at the forefront of biologics development
Apply innovative technical ability and knowledge to critically analyze experimental data and results
Set clearly defined goals/objectives to ensure delivery of high-quality results
Provide clear communication to functional line management and cross-functional teams regarding progress against technical objectives/milestones
Ensure well-organized, clear and complete records of all activities across areas of responsibility
Approximately 5-10% of domestic and/or international travel