Manager, Contract Manufacturing
Company: Insmed Incorporated
Location: Bridgewater
Posted on: March 4, 2026
|
|
|
Job Description:
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: Manager, Contract
Manufacturing will be responsible for the development,
optimization, scale-up, and routine execution of manufacturing
operations for pharmaceutical products. A focus for this role is
some on-site presence at contract manufacturing organizations
(CMOs) during production in Greenville, NC). You will collaborate
with cross-functional teams, including R&D, manufacturing,
quality assurance, regulatory CMC, and CMOs to ensure robust and
compliant production processes. What You'll Do: In this role, you
will have the opportunity to provide CMO Oversight: Real-time and
on-site supervision of CMOs execution of routine manufacturing as
well as technology transfer, optimization, and validation
activities. You will also: Process Development & Optimization:
Design, develop, and optimize manufacturing processes for
pharmaceutical APIs and formulations; with an emphasis on oral
solid tableting. Scale-Up & Tech Transfer: Contribute to the
transition of tablet manufacturing and other drug product processes
from pilot and commercial scale at primary and secondary CMOs.
Equipment & Operations: Troubleshoot of drug product process
equipment, ensuring efficiency and compliance with GMP regulations.
Process Validation: Develop and execute validation protocols (IQ,
OQ, PQ) for oral solid tableting manufacturing and other drug
product processes. Prepare finalized tablet processes for product
registration, validation, and commercial readiness.
Cross-Functional Collaboration: Work closely with formulation
scientists, manufacturing teams, and regulatory affairs to ensure
smooth product development and commercialization. Regulatory
Compliance: Ensure all processes comply with FDA, EMA, and ICH
guidelines for pharmaceutical manufacturing. Data Analysis &
Reporting: Analyze process data, identify critical process
parameters, and prepare technical reports for internal and
regulatory submissions. Who You Are: You have a minimum of a
Bachelor’s degree in Chemical Engineering or equivalent as well as
5 years of experience in pharmaceutical process engineering,
leading teams tasked with implementation of pharmaceutical
manufacturing technology improvements within a regulated
environment. You also have: Experience with late phase clinical and
commercial CMO operations. Strong background in oral solid tablet
manufacturing and primary packaging a plus. Working knowledge of
quality systems, validation principles, engineering design, and
statistical process control fundamentals. Proven ability to
identify, assess, and solve problems using root cause analysis
methodology and document investigation and outcomes in a compliant
manner. Familiarity with DOE (Design of Experiments) and
statistical process control. Experience with GMP manufacturing,
technology transfer, process scale-up, and validation. High energy,
innovative “can do” attitude is required. Ability to work
independently, remote from central leadership. Onsite at CMO in
Greenville, NC (at least 25%) and some international travel. Pay
Range: $124,000.00-161,000.00 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.
Keywords: Insmed Incorporated, West Orange , Manager, Contract Manufacturing, Healthcare , Bridgewater, New Jersey