Associate Director, Manufacturing Science & Technology (MSAT) - Insmed Incorporated
San Diego, CA 92121
About the Job
Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.
Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.
Recognitions:Named Science’s Top Employer in 2021, 2022, and 2023 Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That’s why we were named the No. 1 company to work for in the biopharma industry in Science’s Top Employers Survey for three years in a row. | |
A Certified Great Place to Work® We believe our company is truly special, and our employees agree. In July 2024, we became Great Place to Work-certified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, PEOPLE® Companies That Care, Best Workplaces for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists. | |
Overview:Join the Technical Operations team as Associate Director of MSAT where you will support pipeline programs that change lives. At Insmed Gene Therapy you will be part of a collaborative team that works in a face paced and dynamic environment to bring viral vector gene therapies to market. Supporting our external manufacturing partners, you will be the process and data expert and work to further improve the process of manufacturing AAV based therapies. Working closely with Process Development and CMC teams you will be the bridge between the laboratory and GMP manufacturing.Responsibilities:
- Works with management to plan and execute the MSAT department strategy for technology transfer from process development through to commercial manufacturing.
- Facility fit assessment, tech transfer activities, coordination of process start-up activities including Engineering Runs, GMP/clinical, PPQ and routine commercial runs, and resulting risk mitigation activities.
- Supports manufacturing activities with active process monitoring and data trending, process deviation resolution, process improvements and scientific expertise in the Drug Substance and Drug Product.
- Provides strong technical leadership to process engineers, scientists, and associates for clinical and commercial production.
- May representInsmed Gene Therapy as subject matter expert during external and internal regulatory submissions and compliance inspections.
- Travel will be required to support person-in-plant activities during production campaigns.
- Completes impact assessments for supplier change notifications and authors campaign summary reports.
- Will lead planning activities for process characterization and PPQ planning activities.
- Review batch records, SOPs, raw material specifications, development reports and GMP protocols.
- Support change control and the change management of different process versions and comparability assessments for process changes.
- BS, MS, or PhD in Biotechnology, Chemical or Pharmaceutical Engineering, or related field alongside significant leadership experience across Bioprocessing leadership and 8-10 years of work experience
- Broad experience in all process areas (Upstream cell culture, downstream processing, and buffer) as well as drug product.
- Experience leading and/or interacting with GMP manufacturing, process validation, and tech transfer teams.
- Domestic and/or International travel required (20-40%)
We’re committed to investing in every team member’s total well-being, now and in the future. We offer a competitive total-rewards package to all employees around the world, including:
- Flexible approach to where and how we work, regionally based
- Competitive compensation package including bonus
- Stock options and RSU awards
- Employee Stock Purchase Plan (ESPP)
- Flexible Vacation Policy
- Generous paid holiday schedule and winter break
ADDITIONAL U.S. BENEFITS:
- 401(k) plan with company match
- Medical, dental, and vision plans
- Company-provided Life and Accidental Death & Dismemberment (AD&D) insurance
- Company-provided short and long-term disability benefits
- Unique offerings of pet, legal, and supplemental life insurance
- Flexible spending accounts for medical and dependent care
- Accident and Hospital Indemnity insurance
- Employee Assistance Program (EAP)
- Mental Health on-line digital resource
- Well-being reimbursement
- Paid leave benefits for new parents
- Paid time off to volunteer
- On-site, no-cost fitness center at our U.S. headquarters
Insmed Incorporated is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, disability, age, sexual orientation, gender identity, national origin, veteran status, or genetic information or any other characteristic protected by law.
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.
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.
Applications are accepted for 5 calendar days from the date posted or until the position is filled.
