Manager, Manufacturing Science & Technology
Job Location:
San Diego, CA - USA
Yearly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
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 youll be part of a community that prioritizes the human experience celebrates curiosity and values every persons contributions to meaningful progress. That commitment has earned us recognition as Science magazines 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 were in. Are you
About the Role:
Were looking for a Manager Manufacturing Science & Technology on the Manufacturing team to help us expand whats possible for patients with serious diseases. Reporting to the Associate Director Manufacturing Sciences & Technology youll be responsible for playing a critical role in bringing rAAV-based therapies to market by closely supporting our external manufacturing partners. You will serve as a critical technical bridge between Process Development CMC and GMP manufacturing ensuring process robustness seamless technology transfer and sustained manufacturing excellence across development and commercial stages. The ideal candidate will possess a good understanding of state-of-the-art AAV manufacturing knowledge including suspension HEK293 cell culture and ultracentrifugation-based separation processes as well as exposure to gene therapy regulatory requirements across early and late phases.What Youll Do:
In this role youll have the opportunity to lead and execute end-to-end technology transfer activities from process development through commercial-scale GMP manufacturing including facility fit assessments and coordination of process start-up also be responsible for:
- Review critical documentation including both pre- and post-execution batch records SOPs raw material specifications development reports and GMP protocols
- Serve as a person-in-plant during production campaigns providing real-time support and ensuring alignment with established process parameters and quality standards
- Perform active process monitoring and data trending and assist in and process improvements for the manufacture of Drug Substance and Drug Product
- Drive timely closure of process deviations in Veeva by partnering with cross-functional teams leveraging expertise in document management systems to ensure compliance and traceability
- Support change control management for process versions and process comparability assessments
- Assist with planning and execution for process characterization and Process Performance Qualification (PPQ) activities
- Provide broad technical support across MSAT initiatives as needed such as assistance with Statement of Work (SOW) review and submission and contribute to supply chain risk mitigation efforts
Who You Are:
You have a Bachelors degree along with 5 years of relevant experience in Biotechnology Chemical Engineering Pharmaceutical Engineering or a related field. You are or you also have:
- Solid technical background in drug substance (upstream cell culture downstream purification) and/or drug product operations.
- Hands-on experience interacting with GMP manufacturing process validation and tech transfer teams.
- Ability to work in a fast-paced and dynamic environment.
- Ability to work independentlyremotefrom central leadership.
- Strong interpersonal skills and the ability to work in afast paced multidisciplinary environment.
- Strong verbal and written communication skills are essential.
Nice to have (but not required):
- Expertise of drug product fill process is a plus.
Where Youll Work
- This is a fully remote role. It can be performed effectively from anywhere while staying connected to your Insmed team and community. Occasional travel for team meetings or events will be expected. Candidates located on the East Coast particularly in Ohio Massachusetts and Rhode Island are strongly encouraged to apply.
Travel Requirements
This position involves frequent global travel (up to 40%) for visits to our CDMO sites.
#LI-BA
#LI-REMOTE
Pay Range:
$127000.00-165500.00 AnnualLife at Insmed
At Insmed youll find a culture as human as our missionintentionally 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 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:
Required Experience:
Manager
