Principal Engineer, Manufacturing Sciences and Technology

3 weeks ago

Burlington, United States Sarepta Therapeutics Full time

With the exciting advancement of multiple gene therapy programs from early clinical to pivotal and commercial stages, we are actively recruiting for Principal Engineer/Senior Manager to support Sarepta's diverse gene therapy portfolio and to deliver new treatments for patients. This position will provide great opportunities to support current and future CMOs for commercial production of gene therapy products.

This position will report to the Director of the Commercial MSAT team and will be responsible for providing technical support to late-stage and commercial gene therapy programs. This person will be responsible for data acquisition & analysis, providing technical leadership for critical investigations, process changes, and continuous improvement projects to ensure uninterrupted product supply.

The ideal candidate should be well-versed in all CMC aspects of early clinical, late-stage, and commercial programs. Previous experience working with cross-functional teams in a GMP setting is essential for this role.

Primary Responsibilities Include:

  • Support viral vector and plasmid manufacturing at CMOs.
  • Evaluate process issues using statistical tools and provide remediation to ensure product safety and quality.
  • Technical SME for setting up systems for data acquisition from GMP sources.
  • Perform data analysis and generate process insights.
  • Establish process monitoring programs, evaluate process health, and provide updates to key stakeholders.
  • Support continued process verification program and Annual Product Reviews (APRs)/Product Quality Reviews (PQRs).
  • Lead technical discussions to support critical deviations, change controls, and CAPAs.
  • Review and approve quality documents from CMOs including but not limited to deviation reports, change controls, and CAPAs.
  • Support regulatory document creation including BLA submission and lead response authoring to regulatory questions (RTQ)
  • Train colleagues with MSAT processes as needed.
  • Manage the work of junior members of the team when needed.
  • Flexible and able to adapt to company growth and evolving responsibilities.
  • 10-20% travel anticipated.
Desired Education and Skills:
  • Advanced degree in Engineering or Life/Pharmaceutical Sciences.
  • 8+ years of process development, MSAT, and/or manufacturing experience.
  • Demonstrated understanding of regulatory and cGMP requirements
  • Experience with risk assessments, technology transfer, and commercial manufacturing operations.
  • Knowledge of regulatory, validation, and documentation requirements for product development, commercial production, and site transfer.
  • Strong skills in data trending and analysis using statistical software.
  • Strong collaborative and communication skills, and the ability to work well in a cross-functional, matrixed environment are essential.
  • Ability to prioritize and perform multiple tasks.


#LI-Hybrid

This position is hybrid, you will be expected to work on site at one of Sarepta's facilities in the United States and/or attend Company-sponsored in-person events from time to time.

Candidates must be authorized to work in the U.S.

Sarepta Therapeutics offers a competitive compensation and benefit package.

Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.

  • Principal Engineer, Manufacturing Sciences and Technology

    3 weeks ago

    Burlington, United States Sarepta Therapeutics Full time

    With the exciting advancement of multiple gene therapy programs from early clinical to pivotal and commercial stages, we are actively recruiting for Principal Engineer/Senior Manager to support Sarepta's diverse gene therapy portfolio and to deliver new treatments for patients. This position will provide great opportunities to support current and future CMOs...

  • Principal Engineer, Manufacturing Sciences and Technology

    3 weeks ago

    Burlington, United States Sarepta Therapeutics Full time

    With the exciting advancement of multiple gene therapy programs from early clinical to pivotal and commercial stages, we are actively recruiting for Principal Engineer/Senior Manager to support Sarepta's diverse gene therapy portfolio and to deliver new treatments for patients. This position will provide great opportunities to support current and future CMOs...

  • Principal Engineer, Manufacturing Sciences and Technology

    1 week ago

    Burlington, United States Sarepta Therapeutics Full time

    With the exciting advancement of multiple gene therapy programs from early clinical to pivotal and commercial stages, we are actively recruiting for Principal Engineer/Senior Manager to support Sarepta's diverse gene therapy portfolio and to deliver new treatments for patients. This position will provide great opportunities to support current and future CMOs...

  • Manufacturing Engineer

    2 weeks ago

    Burlington, United States Glaukos Corporation Full time

    Job DescriptionGLAUKOS - MANUFACTURING ENGINEER (Burlington, MA)How will you make an impact? Performs a variety of manufacturing engineering activities on ocular related products including manufacturing scale up, development, and sustaining activities. Responsibilities include developing creative solutions to manufacturing problems, development and execution...

  • Manufacturing Engineer

    3 weeks ago

    Burlington, United States Glaukos Corporation Full time

    Job Description GLAUKOS - MANUFACTURING ENGINEER (Burlington, MA) How will you make an impact? Performs a variety of manufacturing engineering activities on ocular related products including manufacturing scale up, development, and sustaining activities. Responsibilities include developing creative solutions to manufacturing problems, development and...

  • Principal Software Engineer

    1 month ago

    Burlington, United States Robert Half Full time

    Principal Software Engineer (Burlington Massachusetts / Paid relocation)Our Client, a leader in additive manufacturing, seeks a Principal Software Engineer. In this role, you'll lead a team in developing real-time C++ software for our cutting-edge metal 3D printing technology. Your responsibilities include architecting and implementing software for our...

  • Principal Software Engineer

    1 month ago

    Burlington, United States Robert Half Full time

    Principal Software Engineer (Burlington Massachusetts / Paid relocation)Our Client, a leader in additive manufacturing, seeks a Principal Software Engineer. In this role, you'll lead a team in developing real-time C++ software for our cutting-edge metal 3D printing technology. Your responsibilities include architecting and implementing software for our...

  • Principal Software Engineer

    1 week ago

    Burlington, United States Robert Half Full time

    Principal Software Engineer (Burlington Massachusetts / Paid relocation)Our Client, a leader in additive manufacturing, seeks a Principal Software Engineer. In this role, you'll lead a team in developing real-time C++ software for our cutting-edge metal 3D printing technology. Your responsibilities include architecting and implementing software for our...

  • Principal Software Engineer

    3 weeks ago

    Burlington, United States Ciena Full time

    Principal Software Engineer page is loaded Principal Software Engineer Apply locations Remote-US US- MA- Burlington- 154 Middlesex Turnpike time type Full time posted on Posted 30+ Days Ago job requisition id R024219 Ciena is committed to our people-first philosophy. Our teams enjoy a culture focused on prioritizing a personalized and flexible work...

  • Principal Software Engineer

    2 weeks ago

    Burlington, United States Ciena Full time

    Principal Software Engineer page is loaded Principal Software Engineer Apply locations Remote-US US- MA- Burlington- 154 Middlesex Turnpike time type Full time posted on Posted 30+ Days Ago job requisition id R024219 Ciena is committed to our people-first philosophy. Our teams enjoy a culture focused on prioritizing a personalized and flexible work...

  • Sr Principal Software Engineer

    1 month ago

    Burlington, United States Cadence Design Systems Full time

    Sr Principal Software Engineer page is loaded Sr Principal Software Engineer Apply locations BURLINGTON 01 time type Full time posted on Posted 7 Days Ago job requisition id R45064 At Cadence, we hire and develop leaders and innovators who want to make an impact on the world of technology. Job Title: Sr Principal Software Engineer Location: Boston,...

  • Principal Electrical Engineer

    4 weeks ago

    Burlington, United States InnoTech Staffing Full time

    Job Description Job Description Principal Electrical Engineer - Join the Innovation Revolution in Medical Devices! Are you ready to shape the future of healthcare through cutting-edge technology? We are a dynamic, mission-focused company on the forefront of developing a revolutionary therapeutic system, and we're looking for a passionate Principal Electrical...

  • Principal Electrical Engineer

    4 weeks ago

    Burlington, United States InnoTech Staffing Full time

    Job DescriptionJob DescriptionPrincipal Electrical Engineer - Join the Innovation Revolution in Medical Devices!Are you ready to shape the future of healthcare through cutting-edge technology? We are a dynamic, mission-focused company on the forefront of developing a revolutionary therapeutic system, and we're looking for a passionate Principal...

  • RSA - Principal Software Engineer

    2 weeks ago

    Burlington, United States RSA Security Full time

    RSA - Principal Software Engineer RSA provides trusted identity and access managementfor 12,000 organizations around the world, managing 25 million enterprise identities and providing secure, convenient access to millions of users. RSAspecializes in empowering security-first organizations in financial services, healthcare, energy, technology services, and...

  • RSA - Principal Software Engineer

    3 weeks ago

    Burlington, United States RSA Security Full time

    RSA - Principal Software Engineer RSA provides trusted identity and access managementfor 12,000 organizations around the world, managing 25 million enterprise identities and providing secure, convenient access to millions of users. RSAspecializes in empowering security-first organizations in financial services, healthcare, energy, technology services, and...

  • RSA - Principal Software Engineer

    3 hours ago

    Burlington, United States RSA Security Full time

    RSA - Principal Software Engineer RSA provides trusted identity and access managementfor 12,000 organizations around the world, managing 25 million enterprise identities and providing secure, convenient access to millions of users. RSAspecializes in empowering security-first organizations in financial services, healthcare, energy, technology services, and...

  • RSA - Principal Software Engineer

    2 weeks ago

    Burlington, United States RSA Security Full time

    RSA - Principal Software Engineer RSA provides trusted identity and access managementfor 12,000 organizations around the world, managing 25 million enterprise identities and providing secure, convenient access to millions of users. RSAspecializes in empowering security-first organizations in financial services, healthcare, energy, technology services, and...

  • Principal Electrical Engineer

    3 weeks ago

    Burlington, United States X4lifesciences Full time

    23 hours ago Be among the first 25 applicants Direct message the job poster from X4 Life Sciences Connecting exceptional talent in the Medical Device Industry Role overview: This position requires providing technical leadership and direction to companies team members. The chosen candidate will collaborate with the Director and engineering managers to set...

  • Senior Principal Software Engineer

    2 weeks ago

    Burlington, United States Oracle Full time

    We’re looking for an experienced Senior Principal Software Engineer and thought leader to join our growing team focused on rationalizing data management and analytics in OCIs hardware and data center space. We are rapidly expanding our existing big data and analytics platform to cover many more internal customers and use cases, growing scale, stream...

  • Senior Manufacturing Engineer

    2 weeks ago

    Burlington, United States Desktop Metal Full time

    Desktop Metal (NYSE: DM) is pioneering a new generation of additive manufacturing technologies focused on the production of end-use parts. We offer a portfolio of integrated additive manufacturing solutions for engineers, designers and manufacturers comprised of hardware, software, materials and services. Our solutions span use cases across the product life...