- IND to BLAExperience in preparing and defending CMC regulatory filingsDemonstrated ability to build and maintain positive and collaborative relationships with management, peers, subordinates, and externally with third party contract organizationsSelf motivated, assertive, and self confident with the ability to act with urgency and passionProven ability to work with a high level of integrity, accuracy, and attention to detailStrong organizational skills in order to maintain a high level of productivity, innovation, and priority setting in order to complete assignments on time and on budgetExcellent oral and written communication skills for effectively interfacing with all levels of management and departments within the companyEnjoys working in a fast paced, small company environmentAll Kiniksa new hires whose roles require them to enter Kiniksas physical offices will be required to provide documentation that they are fully vaccinated against COVID 19 or, if not, that they are legally entitled to an accommodation due to a medical condition or a sincerely held religious belief.
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Director, Analytical Sciences - Lexington, United States - Kiniksa Pharmaceuticals
Description
Reporting to the Senior Director, AS&QT, the Director, AS&QT will be responsible for managing the analytical sciences needs of Kiniksas pipeline, from discovery to commercial stages.
Technical collaboration and integrated planning with Kiniksas internal CMC teams and associated CMO/CRO organizations are key success factors, along with expert leadership for the completion of planned analytical activities in accordance with agreed scope, timing and budget.
In addition, this position will be required to actively support the preparation of regulatory filings. This role is based out of Kiniksa's Lexington, MA office location. Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote.Responsibilities (including, but not limited to):Formulate and execute characterization and comparability strategy for products and methods with little to no input from managerDemonstrate leadership skills and planning and organizational capabilities.
Effectively implement work plans cross-functionallyCommunicate strategies clearly and effectively, internally and externallyHave a full grasp of all analytical activities occurring internally and externally.
This includes seeing around corners and planning for any potential issuesUnderstand the biologics development process, from discovery to commercial. Be an expert in the requirements of analytical development. Understand the difference between compendial requirements and industry standard practicesEffectively track and manage analytical activities.Have an attention to detail so that no gaps ariseWrite, review, and approve analytical results, protocols, and reports ensuring compliance with all applicable GMP standards, when applicableWrite, review, and approve regulatory reports, submissions, and responses ensuring compliance with all applicable regulatory guidelines, including analytical results, protocols, and reportsIdentify risks associated with AS&QT deliverables, communicate risks, and propose and formulate mitigation strategiesUnderstand current regulatory and quality requirements for AS&QT deliverablesCollaborate with external contract testing laboratories and assess opportunities for bringing work in-houseQualifications:Requires Ph.
D., M.S., or B.S.in Analytical Chemistry, Biochemistry or related field with 10+ years industry experience, respectively, in analytical development for biologicsLarge molecule experience is required.
Experience with mAbs preferredExtensive experience with product and method characterization required. Expertise in mass spectrometry highly desiredProven ability to manage projects and work with cross-functional teams comprised of internal and/or external laboratoriesKnowledge of analytical testing concepts and cGMPs including laboratory controls and good documentation practices across development stages from pre
