Director, Downstream Process Development and Manufacturing Biologics

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 Science 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 The Sunday Times Best Places to Work list in the UK. For patients, for each other, and for the future of science, we’re in. Are you? About the Role: We’re looking for a Director, Downstream Process Development and Manufacturing Biologics on the Technical Operations CMC team to help us expand what’s possible for patients with serious diseases. Reporting to the Executive Director, Pharmaceutical Development you’ll provide strategic and technical leadership for the development, scale up and technology transfer of purification processes for therapeutic proteins, including monoclonal antibodies (mAbs), antibody-drug conjugate (ADCs), and microbial derived biologics. You are responsible for leading and mentoring technical teams, while managing timelines, budgets, and external partnerships. What You'll Do: In this role, you’ll have the opportunity to lead end to end downstream process development activities across all unit operations including viral clearance, process characterization (QbD), process validation and BLA enabling activities to support clinical and commercial manufacturing. You’ll also: Develop and implement phase appropriate downstream purification strategies for early/late-stage pipeline projects, ensuring high product purity and quality Direct the development and transfer of processes to Contract Manufacturing Organizations (CMOs) and oversee scale-up to pilot/GMP commercial production Provide technical oversight and direction to CDMO partners to ensure robust, scalable, and compliant manufacturing processes Define and oversee viral safety strategies, including viral inactivation, viral filtration (VF), and chromatography-based clearance steps Supervise the development of filtration (VF, UFDF) and chromatography steps. Implement Quality by Design (QbD) principles for process characterization and validation Establish and maintain an understanding of current trends and emerging downstream process technologies to ensure that team is at the forefront of biologics development Author and review technical documents, including BLA filings, CMC sections, and viral clearance studies Provide coaching, mentoring, and technical guidance to support scientific growth and career development Collaborate cross-functionally with internal stakeholders across process development, analytical development, project management, CMC lead, CMC Regulatory and quality departments to align technical strategies with organizational and business objectives Who You Are: You have a PhD along with at least 5 years of industry experience or MS with at least 8 years of industry experience. You are or you also have: Downstream process development and manufacturing of biologics (e.g., antibodies, ADC, fusion proteins) Deep experience with chromatography systems, filtration, viral inactivation/removal, and CDMO management Experience and knowledge in process characterization and process validation Extensive understanding of cGMP regulations and ICH guidelines Willingness to work collaboratively by incorporating diverse perspectives and appropriately managing relationships to strength decision-making Nice to have (but not required): Degree in Chemical Engineering, Biotechnology or relevant scientific field Where You’ll Work This is a hybrid role based out of our Bridgewater, NJ office. You’ll have the option to work remotely most of the time, with in-person collaboration when it matters most. Travel Requirements This role requires occasional travel (approximately 10%–20%). #LI-MC1 #LI-HYBRID Pay Range: $177,000.00-242,000.00 Annual Life at Insmed 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. Highlights of our U.S. offerings include: Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP) Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration 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 Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back Eligibility for specific programs may vary and is subject to the terms and conditions of each plan. Current Insmed Employees: Please apply via the Jobs Hub in Workday. 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. 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. 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. 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 View email address on click.appcast.io 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. Applications are accepted for 5 calendar days from the date posted or until the position is filled. For New York City Residents: 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. If you are an applicant for this role and a New York City resident, you have the right to request: A reasonable accommodation, if one is available under applicable law, by emailing View email address on click.appcast.io; and/or An alternative selection process by emailing View email address on click.appcast.io. Information about the type of data collected, the source of that data, and data retention practices related to the AEDT by emailing us at View email address on click.appcast.io. Insmed is a people-first global biopharmaceutical company driven to transforming the lives of patients with serious and rare diseases. Headquartered in Bridgewater, NJ, with locations across the U.S., EMEA, and Japan, we’re guided by our core values and a shared commitment to patients and each other. We’ve been named Science’s No. 1 Top Employer four years in a row, certified as a Great Place to Work in the U.S., and recognized among The Sunday Times’ and BioSpace’s Best Places to Work. For patients, each other, and the future of science, we’re in. Are you? Wherever you are in the world or in your career, we want to stay connected. Sign up for our talent community to hear about new career opportunities, company news, and how our teams around the world are striving to make a difference for patients every day. 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