JOB TITLE: Senior 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, KY or WA.
REPORTS TO: Director, MSAT
SALARY RANGE:$180,000 to $202,000ABOUT THE POSITIONAurion Biotech is a rapidly growing biotech focused on developing innovative cell therapies to treat ocular diseases. We are looking for a Senior Principal Engineer, MS&T individual contributor with deep technical expertise to provide technical management and leadership of a late-stage, commercial combination cell therapy product tech transfers. This individual will lead tech transfer activities including site readiness, new cleanroom expansions, new site tech transfers, risk assessments, preparation support for regulatory documents, comparability/validation campaigns, and ongoing process support to enable late-stage clinical and commercial manufacturing. 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- Tech transfer lead accountable for success of one or more tech transfers to manufacturing sites supporting late-stage clinical and commercial programs, overseeing CMC strategy implementation and managing CDMOs during tech transfer.
- Lead new site/suite readiness activities, including risk assessments, tech transfer strategy, planning, proactive risk mitigations, and execution of feasibility, engineering runs, comparability/PPQ runs.
- Provide strategic input on and author sections of CMC regulatory submissions. Provide immediate response support, as required.
- Collaborate with manufacturing sites to ensure technology, equipment, personnel, and documentation are in place to support continuous GMP manufacturing. Ensure effective business continuity plans.
- Support GMP manufacturing execution, including on-site presence during initial campaign activities, PiP, troubleshooting issues, and driving investigations to closure.
- Own or support creation of key technical documents, including process control strategy, tech transfer plans, batch records, risk assessments, change/site comparability assessments, and change controls.
- Ensure cross-functional alignment with Process Development, Process Sciences, External Manufacturing, Manufacturing Validations, Quality, Regulatory, and Supply Chain to execute tech transfers and implement process improvements.
- Deliver high-quality tech transfer to site GMP commercial readiness with accelerated timelines.
- Establish with site manufacturing data capture during tech transfer and ongoing trending. Perform data and statistical analysis with JMP, as required.
- Drive deviation and change-control impact assessments, ensuring robust root-cause analysis and timely closure of GMP investigations.
- Monitor Drug Substance and Drug Product performance metrics and recommend improvements in process consistency, yield, or compliance.
- Other duties as assigned.
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.
- 12+ years of experience w/ a B.S.; 10+ years of experience w/ M.S., 6+ years of experience with PhD.
- Technical SME and individual contributor with 5+ years of experience in MS&T, Manufacturing or Process Development for biologics/cell therapies; experience leading cross-functional teams, managing CDMOs, delegating responsibility, and solving complex problems.
- Experience with late-stage and commercial cell therapy required. Experience with multiple commercial manufacturing facilities and multiple commercial cell therapy products, a plus.
- Proven track record and hands-on experience with leading late-stage/commercial tech transfers including managing CDMOs, process changes, technical deviations, comparability studies, and PPQ for cell therapies.
- Experience authoring and defending CMC sections of regulatory submissions and regulatory inspections.
- Solid understanding of GMPs, ICH guidelines, and regulatory expectations for cell therapies.
- Experience with cell therapy products is highly preferred.
REQUIRED SKILLS, KNOWLEDGE, AND ABILITIES- Background in cell therapy, viral vector, or other complex biologic modality.
- Demonstrated track record managing new site tech transfers to enable manufacturing product in a fast-paced, evolving environment.
- Strong analytical and problem-solving skills with a data-driven mindset.
- Expertise in deviation management, change control, and CAPA.
- Experience managing direct reports, a plus.
- Strong technical writing and document review capabilities.
- Skilled in problem-solving, process troubleshooting, and data analysis.
- Collaborative and agile with the ability to work effectively in cross-functional teams.
- Excellent communication and organizational skills; able to manage multiple priorities.
- Proficiency with project management tools and data analysis platforms (e.g., JMP, Excel).
- Travel required up to 35%.
Salary Description
$180,000 to $202,000
