Principal Engineer I, MSAT
Principal Engineer I, MSAT
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
Position Summary:
ultrafocused Work together to fearlessly uncover new possibilities
The Principal Engineer I in MSAT will provide technical leadership to support both early- and late-stage AAV GMP manufacturing at internal and contract gene therapy facilities. Reporting to the Sr. Director of MSAT this role will focus on developing data management solutions to enable monitoring the ongoing GMP production and drive process improvements for future lifecycle management. The ideal candidate will bring a strong foundation in biologics/AAV process knowledge combined with statistical expertise. Success in this role requires a high degree of professionalism cross-functional collaboration and an innovative mindset.
Work Model:
Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site.
Responsibilities:
- Build and implement the Continued Process Verification (CPV) framework for AAV programs including online/offline data management solutions data integrity verification process statistical tools and predictive models to monitor and improve batch performance.
- Establish and oversee systems for data collection monitoring and analysis systems for early and late-stage programs ensuring compliance with 21 CFR Part 11 and alignment with regulatory expectations.
- Develop and apply advanced statistical data modeling approaches (e.g. multivariate analysis regression machine learning techniques) to enable predictive modeling deviation investigations and continuous improvement.
- Support deviation investigations and tech transfer activities by leveraging statistical expertise to analyze historical data and to set or revise in-process control limits.
- Lead initiatives to develop platform process models (HEK vs. HeLa) across multiple GMP manufacturing sites to support proactive process monitoring; stay current with the AAV manufacturing technology innovations and support implementation of process improvements for life cycle management.
- Collaborate with Global CMC Development external CDMOs Manufacturing Quality Assurance Quality Control and other stakeholders to enable robust CPV strategy execution.
- Contribute to regulatory filings by authoring CPV-related content responding to agency inquiries and authoring sections of briefing books and submissions.
- Author and maintain technical documentation including CPV protocols and reports statistical models SOPs for data management and lifecycle management protocols and reports.
Requirements:
- Masters degree in Virology Molecular Biology Genetics Biochemistry Chemical Engineering Bioinformatics Biostatistics or an equivalent discipline preferred
- 5 years in biopharma industry. Biologics Gene / Cell therapy experience preferred
- Understanding of biologics/AAV manufacturing process is required and experience in manufacturing technical support process development and/or MSAT roles is preferred
- Demonstrated experience in data management process modeling and predictive analytics preferred with GMP environment
- Proficiency in biostatistics and data management tools (e.g. DOE multivariate analysis regression Python/R/SAS).
- Experience with regulatory filing is a plus
- Proven ability to deliver results successfully collaborating with multi-cultural and geographically diverse teams
- Demonstrated ability to work in a team and in a fast-paced environment. Proven ability to independently manage multiple competing priorities while working on multiple projects simultaneously
- Excellent communication and presentation skills
- May require up to 15% travel when necessary. #LI-CK1 #LI-Onsite
The typical annual salary range for this full-time position is listed below. This range reflects the characteristics of the job such as required skills and qualifications and is based on the office location noted in this job posting. The range may also be adjusted based on applicants geographic location.
This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.
Pay Range
$169200 - $209000 USD
Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race color religion gender sexual orientation gender identity/expression national origin/ancestry age disability marital and veteran status and any other status or classification protected by applicable federal state and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law including individuals with disabilities disabled veterans for pregnancy childbirth and related medical conditions and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or in any part of the recruitment process you may contact Talent Acquisition by emailing us at .
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.
Required Experience:
Staff IC
Employment Type
Full Time
