Aurion Biotech
Principal Scientist, Analytical Development
Aurion Biotech, Cambridge, Massachusetts, us, 02140
JOB TITLE:
Principal Scientist, Analytical Development LOCATION:
Cambridge, MA SALARY RANGE:
$163,000 to $180,000. The midpoint of the range is $170,000. The ideal candidate would be hired at or around the midpoint. ABOUT THE POSITION Aurion Biotech is seeking a highly motivated Principal Scientist, Analytical Development in Cambridge, MA. This position will serve as an integral part of a multidisciplinary team to develop, qualify, and transfer in-process control, characterization, and release assays to support early and late-stage clinical manufacturing and testing of cell therapy products. The individual in this role will work collaboratively with the Research, Process Development, Manufacturing, Regulatory, and other groups to ensure assays meet the timeline of characterization and release of cell therapy products. This position will play a critical role in troubleshooting and problem-solving in the analytical development section. KEY RESPONSIBILITIES Responsible for the development, optimization, qualification, and transfer of GMP-compliant analytical methods and materials that meet US FDA and/or EU regulatory requirements for clinical stage, cell therapy products. Develop analytical assays enabling small molecule testing and characterization, including HPLC/UPLC-based analytical capabilities supporting late-stage therapeutics development. Develop reference material and assay controls for late-stage cell therapy development, including assay control cell lines, Master Cell Bank (MCB) and working cell bank (WCB), author cell process reports and method SOPs and other assay control related technical documents. Serve as subject matter expert and collaborate cross-functionally with other functions including Cell Production, Process Development, Manufacturing, Regulatory, and Quality. Author method qualification SOP, method qualification report and test method SOP and other technical documents to support regulatory submissions and other groups. Track progress toward project milestones and ensure that deliverables are met. Experience with Quality Control and regulatory requirements for late-stage method development and documentation are strongly preferred. 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. 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:
Everyone is a shareholder at Aurion Biotech. We offer competitive equity grants, salaries, and bonuses. 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. QUALIFICATIONS & 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. A PhD and 8+ years’ experience in a relevant discipline (immunology, biochemistry, cell biology, biotechnology, or related field) within biotechnology or academia, and specifically in gene and cell therapy. Experience with biological therapeutic products is critical; experience specifically with cell therapy technologies is highly preferred. Demonstrated track record with analytical development supporting early and late-stage development of cell therapies. Deep technical understanding of analytical method development for key assays (Flow Cytometry, automated cell counting, dPCR, qPCR, ELISA, HPLC/UPLC/MSMS, cell-based potency) and associated requirements (validation, stability programs, comparability assessments, etc.) across development is required. REQUIRED SKILLS, KNOWLEDGE, AND ABILITIES The ability to work in a dynamic, fast-paced, matrix environment, manage priorities and maintain timelines for multiple projects. Demonstrated ability to technically troubleshoot and resolve assay challenges to successfully produce cell therapy products at a high-performance rate. Demonstrated ability to develop, qualify/validate, and transfer biologics analytics into manufacturing processes and product testing that meet customer needs is required. The ability to work both independently and in a matrix team environment is essential. Must have strong interpersonal and communication skills, be a team player, and be willing to work in an environment where individual initiative, accountability to the team, and professional maturity are required. Knowledge of Manufacturing to develop and innovate next-generation analytical tools for the characterization and development of cell therapy products. Familiar with data analytics software such as Flowjo, JMP, Minitab, and/or GraphPad Prism.
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Principal Scientist, Analytical Development LOCATION:
Cambridge, MA SALARY RANGE:
$163,000 to $180,000. The midpoint of the range is $170,000. The ideal candidate would be hired at or around the midpoint. ABOUT THE POSITION Aurion Biotech is seeking a highly motivated Principal Scientist, Analytical Development in Cambridge, MA. This position will serve as an integral part of a multidisciplinary team to develop, qualify, and transfer in-process control, characterization, and release assays to support early and late-stage clinical manufacturing and testing of cell therapy products. The individual in this role will work collaboratively with the Research, Process Development, Manufacturing, Regulatory, and other groups to ensure assays meet the timeline of characterization and release of cell therapy products. This position will play a critical role in troubleshooting and problem-solving in the analytical development section. KEY RESPONSIBILITIES Responsible for the development, optimization, qualification, and transfer of GMP-compliant analytical methods and materials that meet US FDA and/or EU regulatory requirements for clinical stage, cell therapy products. Develop analytical assays enabling small molecule testing and characterization, including HPLC/UPLC-based analytical capabilities supporting late-stage therapeutics development. Develop reference material and assay controls for late-stage cell therapy development, including assay control cell lines, Master Cell Bank (MCB) and working cell bank (WCB), author cell process reports and method SOPs and other assay control related technical documents. Serve as subject matter expert and collaborate cross-functionally with other functions including Cell Production, Process Development, Manufacturing, Regulatory, and Quality. Author method qualification SOP, method qualification report and test method SOP and other technical documents to support regulatory submissions and other groups. Track progress toward project milestones and ensure that deliverables are met. Experience with Quality Control and regulatory requirements for late-stage method development and documentation are strongly preferred. 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. 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:
Everyone is a shareholder at Aurion Biotech. We offer competitive equity grants, salaries, and bonuses. 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. QUALIFICATIONS & 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. A PhD and 8+ years’ experience in a relevant discipline (immunology, biochemistry, cell biology, biotechnology, or related field) within biotechnology or academia, and specifically in gene and cell therapy. Experience with biological therapeutic products is critical; experience specifically with cell therapy technologies is highly preferred. Demonstrated track record with analytical development supporting early and late-stage development of cell therapies. Deep technical understanding of analytical method development for key assays (Flow Cytometry, automated cell counting, dPCR, qPCR, ELISA, HPLC/UPLC/MSMS, cell-based potency) and associated requirements (validation, stability programs, comparability assessments, etc.) across development is required. REQUIRED SKILLS, KNOWLEDGE, AND ABILITIES The ability to work in a dynamic, fast-paced, matrix environment, manage priorities and maintain timelines for multiple projects. Demonstrated ability to technically troubleshoot and resolve assay challenges to successfully produce cell therapy products at a high-performance rate. Demonstrated ability to develop, qualify/validate, and transfer biologics analytics into manufacturing processes and product testing that meet customer needs is required. The ability to work both independently and in a matrix team environment is essential. Must have strong interpersonal and communication skills, be a team player, and be willing to work in an environment where individual initiative, accountability to the team, and professional maturity are required. Knowledge of Manufacturing to develop and innovate next-generation analytical tools for the characterization and development of cell therapy products. Familiar with data analytics software such as Flowjo, JMP, Minitab, and/or GraphPad Prism.
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