Director, Upstream Process Development and Manufacturing

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, Upstream PD and Manufacturing on the Process Development and Engineering team to help us expand what’s possible for patients with serious diseases. Reporting to the Executive Director, Pharmaceutical Development, you’ll drive the design, optimization, and scale up of upstream processes for therapeutic biologics. This role is central to advancing our innovative biologics portfolio from early development through commercial readiness. You will oversee upstream process development for modalities including monoclonal antibodies, microbial proteins and fusion proteins. You’ll also oversee CDMO/CMO partners and manage the lifecycle of upstream process development, specializing in cell line characterization, media and feed strategy optimization, upstream process scaling, and the process validation to support clinical and commercial progression.

What You'll Do:

In this role, you’ll have the opportunity to partner closely with drug substance development, analytical development, external manufacturing, supply chain, and broader CMC teams to guide both technical execution and strategic decision making. You’ll also:

• Lead the upstream process development and manufacturing strategy for biologics (mAbs, fusion proteins, or similar). This includes cell line evaluation, media/feed strategy optimization, bioreactor operations, and scale-up
• Serve as the Insmed’s thought leader for biologics manufacturing platforms, innovation, and process robustness
• Identify, evaluate, and implement innovative technologies—such as perfusion systems, single‑use bioreactors, and process intensification—to enhance yield, robustness, and efficiency
• Partner with stakeholders across R&D, Regulatory, Commercial Manufacturing and Quality to ensure alignment from development to commercial readiness
• Manage and oversee relationships with CDMOs for drug substance development, ensuring scientific rigor, quality, and timelines
• Lead or support cell line development activities, including clone selection, evaluation, and characterization
• Oversee the generation, characterization, and qualification of Master Cell Banks (MCB) and Working Cell Banks (WCB)
• Develop and manage program timelines, resource planning, and budgets for upstream initiatives
• Manage deviations and OOT/OOS investigations at CDMOs in collaboration with Quality, External Manufacturing, and Regulatory
• Establish control strategies, validation approaches, and process characterization studies aligned with Quality by Design (QbD) principles
• Author and review regulatory submissions including IND/IMPD filings, briefing documents, and BLAs
• Serve as a subject matter expert during regulatory interactions, audits, and inspections
• Potential future responsibility to build and lead a team of scientists and engineers supporting upstream development from early research through commercialization

Who You Are:

You have a PhD along with 11 years of experience in drug substance development and manufacturing, or a BS/MS with 14 years of relevant experience.

You are or you also have:

• Proven leadership in upstream process development for recombinant proteins, including antibodies, ADCs, and fusion proteins
• Deep expertise in mammalian cell culture technologies
• Demonstrated success scaling processes to pilot and commercial scale and transferring processes to GMP facilities
• Hands‑on experience with bioreactor platforms (Ambr®, benchtop, pilot, and commercial systems)
• Strong track record of delivering programs with CDMOs
• Experience advancing drug substance from IND through late‑stage development and commercialization
• Expertise in process characterization, control strategy development, and PPQ aligned with QbD principles
• Extensive knowledge of cGMPs and regulatory expectations for biologics, with the ability to influence internal decision‑making
• Strong analytical, data interpretation, and scientific communication skills, including regulatory documentation experience
• Demonstrated leadership managing technical teams and driving cross‑functional collaboration

Nice to have (but not required):

• Degree in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences
• Regarding mammalian cell culture technologies, CHO preferred
• Experience with continuous or perfusion‑based bioprocessing

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 domestic and international 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 TotalRewards@insmed.com  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 TotalRewards@insmed.com; and/or

• An alternative selection process by emailing Privacy@insmed.com.

• Information about the type of data collected, the source of that data, and data retention practices related to the AEDT by emailing us at Privacy@insmed.com.