Senior Manager, Formulation and Drug Product Development

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    "requisitionDescription": "<div><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;' data-pasted=\"true\"><span style=\"font-size: 16px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Kiniksa is seeking a highly motivated Senior Manager, Formulation and Drug Product Development, to join our Drug Product Development team in Lexington, MA. &nbsp;Reporting to the Director, Formulation and Drug Product Development, this individual will drive CMC development activities and manage cross-functional projects. This position offers opportunities to make significant contributions to Kiniksa&rsquo;s drug product development and pipeline programs.</span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;'><span style=\"font-size: 16px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">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.</span></p><p style='margin-top:12.0pt;margin-right:0in;margin-bottom:12.0pt;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;line-height:normal;'><span style=\"font-size: 16px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\"><strong>Responsibilities <em>(including, but not limited to)</em>:</strong></span></p><div style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;'><ul style=\"margin-bottom:0in;\"><li style=\"margin: 0in 0in 8pt; font-size: 16px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Lead product candidates&rsquo; manufacturability/developability assessment and collaborate with Discovery team on drug candidate selection</li><li style=\"margin: 0in 0in 8pt; font-size: 16px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Establish formulation screening strategies for high concentration biologics in a dynamic environment</li><li style=\"margin: 0in 0in 8pt; font-size: 16px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Develop, manage, execute, and support clinical in-use studies and other dose administration related studies to support tox and clinical studies.</li><li style=\"margin: 0in 0in 8pt; font-size: 16px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Contribute to the evaluation and selection of CRO and CDMO for development studies and GMP manufacturing</li><li style=\"margin: 0in 0in 8pt; font-size: 16px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Manage external partners (CRO/CDMO) to advance project milestones</li><li style=\"margin: 0in 0in 8pt; font-size: 16px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Support process development studies and DP manufacturing tech transfer</li><li style=\"margin: 0in 0in 8pt; font-size: 16px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Author and review study protocols and reports, summarize and communicate project updates to stakeholders</li></ul></div><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;'><span style=\"font-size: 16px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">&nbsp;</span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;'><span style=\"font-size: 16px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\"><strong>Qualifications:</strong></span></p><div style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;'><ul style=\"margin-bottom:0in;\"><li style=\"margin: 0in 0in 8pt; font-size: 16px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">PhD or MSc with 4+ years of experience in protein chemistry and formulation science, particularly involving parenteral formulations.</li><li style=\"margin: 0in 0in 8pt; font-size: 16px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Previous experience with biologics (such as monoclonal antibody, fusion protein, antibody drug conjugates) required</li><li style=\"margin: 0in 0in 8pt; font-size: 16px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Strong problem-solving skills and excellent communication abilities</li><li style=\"margin: 0in 0in 8pt; font-size: 16px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Ability to manage multiple priorities and work with ambiguity</li><li style=\"margin: 0in 0in 8pt; font-size: 16px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Strong commitment to compliance and ethical standards</li><li style=\"margin: 0in 0in 8pt; font-size: 16px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Ability to travel up to 5%</li><li style=\"margin: 0in 0in 8pt; font-size: 16px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Salary is commensurate with experience</li><li style=\"margin: 0in 0in 8pt; font-size: 16px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\"><a href=\"https://www.kiniksa.com/join-us\" target=\"_blank\" style=\"font-size: 16px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Kiniksa Benefits Summary - USA</a></li></ul></div><p style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;line-height:normal;background:white;'><span style=\"font-size: 16px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">&nbsp;</span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;line-height:normal;background:white;'><span style=\"color: rgb(0, 0, 0); font-size: 16px; font-family: arial, sans-serif;\">The pay range for this position is $174k-191K. Compensation is subject to change commensurate with industry standards and the candidate&rsquo;s relevant experience and qualifications. &nbsp;&nbsp;</span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;line-height:normal;background:white;'><span style=\"font-size: 16px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">&nbsp;</span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;line-height:normal;background:white;'><span style=\"color: rgb(0, 0, 0); font-size: 16px; font-family: arial, sans-serif;\">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.</span></p></div>\n",
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