Scientist II, Analytical Development, Bioassays

<p>At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as <i>Science</i> magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on <i>The Sunday Times</i> Best Places to Work list in the UK.</p><p></p><p>For patients, for each other, and for the future of science, we’re in. Are you?</p><p></p><p style="text-align:inherit"></p><p style="text-align:left"><b>About the Role:</b></p>We’re looking for a Scientist II on the Analytical Development team to help us expand what’s possible for patients with serious diseases. Reporting to the Senior Scientist you’ll support the development of impactful gene therapy products for patients with rare diseases. As a bench scientist, you’ll work within a team devoted to the development of phase-appropriate potency bioassays focused on AAV gene therapy programs. You will be a part of a multidisciplinary team of scientists spanning discovery research, process development, and quality control. Additionally, this role will collaborate with QA, clinical research, regulatory affairs, program management, legal, and finance to advance gene therapy candidates to patients.<p style="text-align:inherit"></p><p style="text-align:left"><b>What You&#39;ll Do: </b></p><p>In this role, your contributions will involve the development, implementation, and transfer of IND-enabling analytical methods from Analytical Development to QC and to contracted organizations to support CMC activities. This role will be responsible for lifecycle management of analytical methods from Phase I to commercialization. You’ll also:</p><ul><li>Design, develop, and execute assay development strategies to produce analytical methods for release and stability testing in a GMP environment</li><li>Serve as a subject-matter-expert for phase-appropriate in vitro potency assays</li><li>Collaborate with research, quality control, and process development teams to develop, transfer, and qualify early phase AAV gene therapy cell-based biological potency assays</li><li>Develop Phase I-appropriate analytical potency bioassays and continue refinement of methods through later phases of method lifecycle</li><li>Monitor analytical method performance</li><li>Actively contribute to the enabling and improvement of analytical development capabilities and processes to support the Quality Team at Insmed Gene Therapy</li><li>Draft and review protocols, SOPs, development reports, and other investigational product documents</li><li>Maintain the Analytical Development laboratory, reagents, and instruments</li><li>Software Use Expectations:<ul><li>JMP statistical software or equivalent software for data analysis, assay tracking and trending, and establishment of system and sample acceptance criteria</li><li>Learn and become proficient in all laboratory instrument software for method development</li><li>Integration of automation into existing workflows</li></ul></li><li>Ensure the accurate documentation and record keeping of all lab and associated work, in adherence with current Good Documentation Practices</li><li>Perform data review to ensure accuracy, completeness, and reliability</li><li>Participate in cross-disciplinary mentoring and training of associate scientists</li><li>Assist with coordination and day-to-day management of site operations</li></ul><p style="text-align:inherit"></p><p style="text-align:left"><b>Who You Are:</b></p><p>You have a BS or equivalent, in biochemistry, cell biology or related field, with a minimum of 5 years of relevant experience; or, Master’s degree in relevant discipline with a minimum of 3 years of relevant experience; or, PhD with a minimum of 1 year of relevant experience.</p><p>You are or you also have:</p><ul><li>Deep technical understanding of, and hands-on experience with, molecular biology, recombinant DNA technology, gene editing techniques, and cell biology</li><li>Cell culture, western blot, electrophoresis, ELISA, flow cytometry, PCR/qPCR/ddPCR, microscopy (bright field, fluorescent, confocal, etc.)</li><li>Experience in optimizing methods with particular emphasis on cell-based potency assays, molecular biology assays, microscopy, and protein chemistry assay</li><li>Proven track record in method development, including experimental design, execution, and evaluation</li><li>Ability to set and meet experimental timelines, ensuring project progression</li><li>Excellent organizational and communication skills (verbal and written), with a strong attention to detail, clarity, accuracy, and conciseness</li><li>Ability to thrive in a dynamic work environment and show commitment to diversity in individuals and ideas, with a strong willingness to take on new challenges required to bring novel medicines to the clinic</li></ul><p><b>Nice to have (but not required):</b></p><ul><li>Significant experience in an FDA-regulated environment is a plus, specifically in the pharmaceutical industry with a GMP testing focus</li></ul><p></p><p><b>Where You’ll Work </b></p><p>This role is based out of our San Diego office and requires full-time, in-person presence to support hands-on collaboration, access specialized equipment, and/or operational needs.</p><p></p><p><b>Travel Requirements</b></p><p>0-15% domestic and/or international travel required for method transfer activities and other business-related travel</p><p></p><p>#LI-POST</p><p>#LI-MC1</p><p style="text-align:inherit"></p><p style="text-align:left"><b>Pay Range:</b></p>$127,000.00-165,500.00 Annual<p></p><p><span style="color:#000000"><b>Life at Insmed</b><br /> </span></p><p>At Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.</p><p></p><p>Highlights of our U.S. offerings include:</p><ul><li><p>Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)</p></li><li><p>Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration</p></li><li><p>401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance</p></li><li><p>Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities</p></li><li><p>Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back</p></li></ul><p></p><p></p><p>Eligibility for specific programs may vary and is subject to the terms and conditions of each plan. </p><p></p><p></p><p></p><p><i><b>Current Insmed Employees: Please apply via the Jobs Hub in Workday.</b></i></p><p></p><p></p><h3></h3><p></p><p><i>Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.</i></p><p></p><p><i>It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.<br /><br />Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.<br /><br />Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application   or interview process, please contact us by email at </i><a target="_blank" href="mailto:TotalRewards&#64;insmed.com"><span style="color:#0000ff"><i><u>TotalRewards&#64;insmed.com</u></i></span></a><i>  and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.<br /><br />Applications are accepted for 5 calendar days from the date posted or until the position is filled.</i></p><p></p><p><i><b>For New York City Residents:</b></i></p><p><i>To assist in identifying candidates with qualifications matching those required and/or preferred for this role, Insmed uses an Automated Employment Decision Tool (“AEDT”) that employs artificial intelligence to analyze and score information provided in resumes and application materials including, but not limited to, skills, work experience, education, and job-related qualifications. The AEDT does not make final hiring decisions and all final hiring decisions are subject to human oversight and/or review.</i></p><p><br /><i>If you are an applicant for this role and a New York City resident, you have the right to request:</i></p><p> </p><ul><li><p><i>A reasonable accommodation, if one is available under applicable law, by emailing </i><a target="_blank" href="mailto:TotalRewards&#64;insmed.com"><span style="color:#1e53a3"><i><u>TotalRewards&#64;insmed.com</u></i></span></a><i>; and/or</i></p></li><li><p><i>An alternative selection process by emailing </i><a target="_blank" href="mailto:Privacy&#64;insmed.com"><span style="color:#1e53a3"><i><u>Privacy&#64;insmed.com</u></i></span></a><i>.</i></p></li><li><p><i>Information about the type of data collected, the source of that data, and data retention practices related to the AEDT by emailing us at </i><a target="_blank" href="mailto:Privacy&#64;insmed.com"><i>Privacy&#64;insmed.com</i></a><i>.</i></p></li></ul>