Assoc Director/Director

Reporting to the Senior Director of Analytical Sciences and Quality Testing (ASQT). The Associate Director/Director of ASQT will lead CMC analytical development activities from Phase 1 to commercial. The successful candidate will be responsible for analytical method development, method qualification/validation, method transfer, CQA and product characterization, reference standard qualification, comparability study and analytical control strategies. The successful candidate will author and review technical protocol/reports, GMP documentations, and regulatory submission. This role requires strong technical expertise, strategic thinking, and collaboration with internal and external teams, including Process Development, Manufacturing, Quality, Regulatory, Facility, partners and vendors. This is an exciting opportunity for the right individual to join the Kiniksa team and advance the pipeline programs with career growth potential. This role is based in our Lexington, MA office. Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote. Responsibilities (includes but not limited to): Lead analytical methods development, optimizations, qualification/validation and transfer activities Coordinate analytical testing (cGMP and non-GMP) Author, review and provide assessment as analytical SME for quality events, including OOS, deviations, investigations, and change controls Maintains current state-of-the-art practices and methods according to industry standards and regulatory guidelines Design product characterization plan and lead product attribute criticality (CQA) assessment, specifications setting, comparability study, and analytical control strategy Lead the reference standard qualification/requalification workflow Author, review and approval of analytical laboratory documentation, including (but not limited to) technical protocol and reports, method qualification/transfer protocols and reports, investigation protocols and reports, certificates of testing/analysis Review of manufacturing batch records with respect to sampling plans and analytical testing. Author and review regulatory submissions Represent ASQT in Tech Op project core team. Collaborate with cross-functional team members to ensure progress analytical development activities Qualifications: MS or Ph.D. in Analytical Chemistry, Biochemistry, or related field, with 8-10+ years experience in CMC analytical development in biotechnology and pharmaceutical industry Large molecule (protein therapeutics) experience is required Expertise in ELISA and/or cell-based assays is highly preferred Commercial or late-stage development experience is preferred Proven ability to manage projects and work with cross-functional teams comprised of internal and/or external contacts, including contract testing laboratories Experienced in preparing and defending CMC regulatory filings Ability to work a flexible work schedule to accommodate program priorities, international activities, and travel as needed Previous experience with data trending and statistical programs (JMP, MiniTab, Excel, etc.) preferred Demonstrated ability to build and maintain positive and collaborative relationships with management, peers, subordinates, and with third-party organizations Self-motivated, assertive, and self-confident with the ability to act with urgency and passion Proven ability to work with a high level of integrity, accuracy, and attention to details Ability to work independently, under minimal supervision, and with the flexibility to handle workflow in a multi-tasking environment Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company Entrepreneurial, enjoys working in a fast-paced, small-company environment. Strong commitment to compliance and ethical standards Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.) Ability to travel up to 5% (domestic and international if needed) Salary is commensurate with experience Kiniksa Benefits Summary - USA 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.