Principal Engineer, MSAT

Aurion Biotech Inc.; Massachusetts; À distance; USD 157 000 - 174 000; Plein temps

Avantages offerts par ce poste

Robust Benefits

Total Rewards

Perks and Fun

Résumé du poste

Aurion Biotech is a rapidly growing biotech focused on developing innovative cell therapies to treat ocular diseases. The Principal Engineer, MSAT will provide technical leadership for technology transfer, comparability, and commercial readiness across GMP manufacturing sites.

This individual contributor will lead complex workstreams spanning site readiness, tech transfer execution, comparability, lifecycle changes, and validation/PPQ support, partnering with GMP manufacturing sites to sustain

Qualifications

• BS/MS/PhD in a scientific or engineering discipline required.
• 10+ years with a BS; 7+ years with an MS; or 5+ years with a PhD of relevant industry experience.
• Experience in MSAT, Manufacturing, Process Development or related functions.
• Experience leading late-stage or commercial technology transfer workstreams with GMP sites.
• Experience with engineering/GMP manufacturing, validation/PPQ, deviations and investigations.
• Experience authoring risk assessments and regulatory documents; regulatory support preferred.
• Ability to lead cross-functional subteams and influence GMP partners.
• Cell therapy experience preferred; multiple sites/products a plus.

Responsabilités

• Lead technical execution of commercial-stage comparability strategies for site transfers.
• Develop workstreams for late-stage and commercial process changes at GMP sites.
• Lead tech transfers including transfer planning, risk assessments, training, and GMP readiness.
• Own documentation such as tech transfer packages, change controls, risk assessments, reports.
• Provide on-site PiP support, drive investigations, deviations, and CAPAs to resolution.
• Analyze manufacturing data to identify variability and opportunities for improvement.
• Manage deviation and change-control impact assessments and timely closures.
• Collaborate with sites to ensure manufacturing readiness and business continuity.

Connaissances

Technology transfer

Commercial comparability

GMP manufacturing

Validation/PPQ

Process control strategy

Data analysis

Cross-functional collaboration

Regulatory documentation

JMP

Formation

BS, MS, or PhD in a scientific or engineering discipline

Outils

JMP

Description du poste

Fully Remote Remote - WA or MA Preferred - WA, NM, SD, TX, IN, SC, NC, PA, NY, NH, KY, WI, MS, MA applicants only

Description

JOB TITLE: Principal Engineer, MSAT

LOCATION: 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, MSAT

SALARY RANGE: $157,000 to $174,000

ABOUT THE POSITION

Aurion Biotech is a rapidly growing biotech focused on developing innovative cell therapies to treat ocular diseases. We are looking for a Principal Engineer, MSAT to provide technical expertise for technology transfer, comparability, and commercial readiness of late-stage and commercial cell therapy products at GMP manufacturing sites.
This 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.

ABOUT AURION BIOTECH

With offices in Seattle, Boston, and Tokyo, Aurion Biotech is a clinical-stage biotech company, whose mission is to restore vision to millions of patients with life-changing regenerative therapies. The Company's first candidate is for the treatment of corneal edema secondary to endothelial dysfunction, and one of the first clinically validated cell therapies for corneal care; it was recently granted regulatory approval from Japan’s PMDA. Aurion Biotech is the recipient of the prestigious Prix Galien award for best start-up in biotech. The Company is preparing for clinical trials in the U.S. We are growing rapidly and seek to hire highly motivated candidates from diverse backgrounds, cultures, and experiences, who share our values:

• Stewardship: We make the world a better place for our patients, our communities, our clinicians, and our colleagues. We act responsibly as individuals, as employees, and as a company.
• Transformation: We embrace our challenges, our successes, and our failures. We are curious, we take risks, and we collaborate.
• Grit: We break down walls and strive to achieve the impossible. We are persistent and resilient, and we deliver on our commitments.

Aurion Biotech has a lot to accomplish in the next few years, and this role is key to our success. Privately held, Aurion Biotech is backed by Alcon, the global leader in eye care. To learn more about Aurion Biotech, visit www.aurionbiotech.com .

LIFE AT AURION BIOTECH

We want our people to wake up every morning excited and energized for work. We value employees, which is why we invest in making life at Aurion Biotech healthy, fun, and rewarding:

• Robust Benefits: We offer full health insurance to employees and their families, and all the acronyms: 401(k) matching, EAP, FSA, and generous PTO.
• Total Rewards: We offer competitive compensation packages to ensure all Aurion employees are rewarded for their hard work.
• Perks and Fun: Paid parking, subsidized commuter passes, in-office catered lunches, team events, and community projects are just a few ways that we bond, celebrate each other, have fun, and live our values.

Requirements

QUALIFICATIONS AND EDUCATION

To 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.