Aurion Biotech
Senior Director, Process Development
Aurion Biotech, Oklahoma City, Oklahoma, United States,
DescriptionTITLE:
Senior Director, Process DevelopmentABOUT THE POSITIONAurion Biotech is seeking a Senior Director, Process Development in Cambridge, MA. The Process Development Senior Director will work closely with non-clinical, clinical, analytical development, manufacturing, regulatory and quality teams. The successful candidate will provide technical and strategic leadership for development activities related to cell production processes, drug product formulation, aseptic filling process, cryopreservation, storage, stability assessment and technology transfer to manufacturing functions. This is an outstanding opportunity for a talented and self-motivated scientist to contribute to bringing cutting-edge cellular therapies to patients while gaining valuable career experience.KEY RESPONSIBILITIESDesign and execute detailed experiments to understand Drug Substance and Drug Product processes and to define robust, integrated process control strategies.Lead tech transfer activities to external manufacturing sitesPerform gap analysis and risk assessments to identify problems and deficiencies, as well as provide recommendations for studies and solutions to manufacturing process and alignment with regulatory and commercial manufacturing requirementsDevelop and implement Process Performance Qualification (PPQ) strategy and post-approval process improvements with effective balance among quality, financial, and inventory risksBuild processes and strong relationships with external manufacturing organizationsSupport regulatory strategy and activities, including authoring and review of CMC documentation for regulatory filingsSupport the development of standard operating procedures, FMEA, batch records, and analytical sampling plansABOUT AURION BIOTECHWith 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.The company is backed by leading investors, including Deerfield, Flying L Partners, Visionary Ventures, KKR’s Falcon Vision Fund, and Petrichor.LIFE AT AURION BIOTECHWe 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.RequirementsQUALIFICATIONS AND EDUCATIONA pertinent PhD in life sciences or engineering, with 10+ years relevant industry experience.Experience in cell therapy is strongly preferred.Ability and track record of successfully supporting biologics programs through late-stage clinical development is required, experience leading process development for cell therapy programs transitioning to late-stage clinical development is preferred.Technology transfer and extensive biologics technical experience is required, experience of technology transfer related to cell therapy programs is preferred.Experience with process characterization and scale-up is required, experience of process characterization and scale-up related to cell therapy programs is preferred.Prior experience in successfully collaborating with manufacturing and quality functions is required.Demonstrated experience leading a diverse technical organization, as well as interfacing with external manufacturing providers, partners, and or academic collaborations.Outstanding communication, analytical and organizational skills.Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between diverse stakeholders.
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Senior Director, Process DevelopmentABOUT THE POSITIONAurion Biotech is seeking a Senior Director, Process Development in Cambridge, MA. The Process Development Senior Director will work closely with non-clinical, clinical, analytical development, manufacturing, regulatory and quality teams. The successful candidate will provide technical and strategic leadership for development activities related to cell production processes, drug product formulation, aseptic filling process, cryopreservation, storage, stability assessment and technology transfer to manufacturing functions. This is an outstanding opportunity for a talented and self-motivated scientist to contribute to bringing cutting-edge cellular therapies to patients while gaining valuable career experience.KEY RESPONSIBILITIESDesign and execute detailed experiments to understand Drug Substance and Drug Product processes and to define robust, integrated process control strategies.Lead tech transfer activities to external manufacturing sitesPerform gap analysis and risk assessments to identify problems and deficiencies, as well as provide recommendations for studies and solutions to manufacturing process and alignment with regulatory and commercial manufacturing requirementsDevelop and implement Process Performance Qualification (PPQ) strategy and post-approval process improvements with effective balance among quality, financial, and inventory risksBuild processes and strong relationships with external manufacturing organizationsSupport regulatory strategy and activities, including authoring and review of CMC documentation for regulatory filingsSupport the development of standard operating procedures, FMEA, batch records, and analytical sampling plansABOUT AURION BIOTECHWith 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.The company is backed by leading investors, including Deerfield, Flying L Partners, Visionary Ventures, KKR’s Falcon Vision Fund, and Petrichor.LIFE AT AURION BIOTECHWe 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.RequirementsQUALIFICATIONS AND EDUCATIONA pertinent PhD in life sciences or engineering, with 10+ years relevant industry experience.Experience in cell therapy is strongly preferred.Ability and track record of successfully supporting biologics programs through late-stage clinical development is required, experience leading process development for cell therapy programs transitioning to late-stage clinical development is preferred.Technology transfer and extensive biologics technical experience is required, experience of technology transfer related to cell therapy programs is preferred.Experience with process characterization and scale-up is required, experience of process characterization and scale-up related to cell therapy programs is preferred.Prior experience in successfully collaborating with manufacturing and quality functions is required.Demonstrated experience leading a diverse technical organization, as well as interfacing with external manufacturing providers, partners, and or academic collaborations.Outstanding communication, analytical and organizational skills.Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between diverse stakeholders.
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