JOB TITLE: Principal Engineer, MSATLOCATION: Remote (WA or MA preferred) - candidates based in the following states will be considered: IN, MA, NC, NJ, NH, NM, NY, PA, SC, SD, TX, MS, WI, KY or WA.
REPORTS TO:Director, MSATSALARY RANGE: $157,000 to $174,000ABOUT THE POSITIONThis individual contributor will independently lead complex technical workstreams spanning site readiness, tech transfer execution, comparability, lifecycle changes, and validation/PPQ support. The Principal Engineer will serve as a technical and GMP SME within cross-functional technical execution, and partner closely with GMP manufacturing sites to transfer and sustain robust, compliant commercial manufacturing processes. If you are a highly motivated and experienced GMP manufacturing professional with a passion for commercializing innovative drug therapies in GMP operations, we encourage you to apply for this exciting opportunity to join our team.
KEY RESPONSIBILITIES- Lead technical execution of commercial-stage comparability strategies supporting site transfers, process, equipment or material changes, etc.
- Develop and lead technical workstreams for late-stage and commercial process changes implementation at GMP sites, including technical risk assessments, change controls, impact assessments, comparability considerations, and GMP implementation.
- Lead complex workstreams within late-stage and commercial tech transfers, including transfer planning, facility/process fit, risk assessments, training, engineering runs, comparability, process implementation, and GMP readiness.
- Own or support technical documentation, including technology transfer packages, change controls, technical risk assessments, comparability plans/data packages/reports, process control strategy, execution protocols/reports, batch records, and regulatory source documents.
- Provide on-site PiP support, troubleshoot process issues, and drive technical investigations, deviations, change controls, and CAPAs to resolution.
- Establish and evaluate manufacturing data and process performance trends using statistical tools; identify variability, shifts, and opportunities to improve process consistency, yield, robustness, and compliance.
- Manage deviation and change-control impact assessments, ensuring robust root-cause analysis and timely closure of tech transfer investigations.
- Collaborate with manufacturing sites to ensure technology, equipment, personnel, and documentation are in place to support continuous GMP manufacturing. Ensure effective business continuity plans.
- Other duties as assigned.
Requirements
QUALIFICATIONS AND EDUCATIONTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- B.S, M.S, or Ph.D. degree in a scientific or engineering discipline required.
- 10+ years with a B.S.; 7+ years with an M.S.; or 5+ years with a Ph.D. of relevant industry experience.
- Significant experience in MSAT, Manufacturing, Process Development, or related functions supporting late-stage or commercial biologics or cell therapies.
- Demonstrated commercial-stage comparability, including comparability supporting manufacturing site transfers, process, equipment, or material changes, or other post-approval/lifecycle manufacturing changes.
- Demonstrated experience leading late-stage or commercial technology transfer workstreams and working directly with GMP manufacturing sites.
- Experience with engineering/GMP manufacturing, validation/PPQ, technical deviations, and manufacturing investigations.
- Experience authoring risk assessments, technical documentation and source documents supporting CMC regulatory submissions; experience supporting regulatory responses or inspections preferred.
- Experience leading cross-functional technical subteams and influencing GMP manufacturing partners through complex technical issues and implementation.
- Cell therapy experience strongly preferred; experience across multiple commercial manufacturing sites or products a plus.
- Solid understanding of GMPs, ICH guidelines, and regulatory expectations for cell therapies.
REQUIRED SKILLS, KNOWLEDGE, AND ABILITIES- Strong knowledge of technology transfer, commercial comparability, GMP manufacturing, validation/PPQ, process control strategy, deviation/change control, and commercial lifecycle management.
- Demonstrated ability to independently lead complex technical workstreams, implement commercial lifecycle changes, and develop technical approaches with limited direction.
- Strong technical writing and document review skills, including risk assessments, protocols/reports, comparability assessments, technical justifications, and regulatory source documents.
- Strong analytical, troubleshooting, and data-analysis skills; JMP or similar statistical experience preferred.
- Ability to lead cross-functional technical subteams, influence external manufacturing partners, and mentor junior technical staff without direct management responsibility.
- Background in cell therapy, viral vector, or other complex biologic modalities with hands-on GMP manufacturing experience preferred.
- Travel required up to 35%.
Salary Description
$157,000 to $174,000
