Process Engineer II, MSAT/ExM at Aurion Biotech

Cambridge, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

27 Apr, 26

Salary

123000.0

Posted On

27 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Process Engineering, GMP Manufacturing, Tech Transfer, Risk Assessments, Troubleshooting, Collaboration, Analytical Skills, Problem Solving, Regulatory Submissions, Documentation, Validation Activities, Data Capture, Training, Manufacturing Improvement, Communication, Interpersonal Skills

Industry

Biotechnology

Description

Description JOB TITLE: Process Engineer II, MS&T/ExM LOCATION: Cambridge, MA (Hybrid) REPORTS TO: Director, Manufacturing SALARY RANGE: $112,000 to $123,000 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 Process Engineer II, MS&T/ExM to provide technical oversight of a late-stage combination cell therapy product, focusing on leading site readiness, new cleanroom expansions, tech transfer, risk assessments, submission of 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 developing and commercializing innovative drug therapies, we encourage you to apply for this exciting opportunity to join our team. KEY RESPONSIBILITIES Support tech transfer activities and GMP operations for late-stage clinical and commercial programs, including PIP support and CDMO collaboration. Participate in new site/suite readiness activities, including risk assessments, tech transfer strategy, planning, and execution of feasibility and engineering runs. Support GMP manufacturing execution, including on-site presence during initial campaign activities, troubleshooting issues, and driving investigations to closure. Develop and maintain strong relationships with internal stakeholders and external partners and ensure strong collaboration and productivity to deliver successful late phase, scale-up cGMP clinical and commercial batches. Support authoring and review of CMC sections of health authority submissions. Provide immediate response support, as required. Own or support creation of key technical documents, including tech transfer plans, batch records, risk assessments, deviation analyses, and change controls. Create process support playbooks and troubleshooting guides. Drive deviation and change-control impact assessments, ensuring robust root-cause analysis and timely closure of GMP investigations. Collaborate with manufacturing sites to ensure technology, equipment, and documentation are in place to support compliant and efficient manufacturing. Contribute to validation activities (e.g., PPQ campaign, process characterization, etc). Support manufacture data capture for trending and CPV. Perform hands-on training in Process Development labs including maintaining cell lines. Ensure cross-functional alignment with Process Development, Process Sciences, Manufacturing Validations, Quality, Regulatory, and Supply Chain to execute tech transfers and implement process improvements. Monitor Drug Substance and Drug Product performance metrics and recommend improvements in process consistency, yield, or compliance. 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. B.S. with 5-7 years or M.S. with 3-5 years of experience in MS&T, External Manufacturing or Process Development for biologics/cell therapies. Experience with tech transfers, scale-up, and validation of cell therapy or other biologics processes preferred. Experience with leadership or project management preferred but not required. Familiarity with the development and implementation of manufacturing improvement strategies (lean principles) for cell therapies is a plus. Knowledge of late-stage and BLA-enabling activities a plus. Experience with late-stage clinical and/or commercial cell therapy manufacturing a plus. REQUIRED SKILLS, KNOWLEDGE, AND ABILITIES Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and external partners. Familiarity with working with GMP manufacturing facilities or CDMOs during tech transfer and/or cGMP manufacturing. Strong analytical and problem-solving skills, with the ability to independently apply scientific and engineering principles to complex technical problems and data trending. Understanding of cGMP regulations and requirements for manufacturing cell therapies or other biologics. Proficiency in authoring and reviewing protocols and reports that support GMP manufacturing and regulatory filings. Ability to meet deadlines, adapt to rapid changes, and work in a fast-paced team environment. Proficient use of MS Office products, JMP or other data analysis software Travel required up to 40%.

How To Apply:

Incase you would like to apply to this job directly from the source, please click here

Responsibilities

The Process Engineer II will provide technical oversight for a late-stage combination cell therapy product, focusing on site readiness, tech transfer, and ongoing process support. Responsibilities include supporting GMP operations, authoring key technical documents, and collaborating with internal and external stakeholders.